adalimumab: package leaflet

Humira contains the active substance adalimumab.

Humira is intended for the treatment of the inflammatory diseases described below:
- Polyarticular juvenile idiopathic arthritis
- Enthesitis-related arthritis
- Paediatric plaque psoriasis
- Paediatric Crohn’s disease
- Paediatric uveitis

The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis.

Your doctor will decide if Humira should be used with methotrexate or alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her enthesitis-related arthritis.

Paediatric plaque psoriasis

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.

Humira is used to treat severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.

Paediatric Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Humira is used to treat moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

Paediatric uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation.

Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

Do not use Humira:

• If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

- If your child has active tuberculosis or other severe infections (see “Warnings and precautions”).
It is important that you tell your doctor if your child has symptoms of infections, for example, fever, wounds, feeling tired, dental problems.

• If your child has moderate or severe heart failure. It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Humira.

Allergic reactions

• If your child gets allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

Infections

• If your child has an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor.

• Your child might get infections more easily while he/she is receiving Humira treatment. This risk may increase if your child has problems with his/her lungs. These infections may be serious and include:
• tuberculosis
• infections caused by viruses, fungi, parasites or bacteria
• severe infection in the blood (sepsis)

In rare cases, these infections can be life-threatening. It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time.

• Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

• Tell your doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.

• Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira. It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your child’s medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your child’s Patient Reminder Card.

• It is very important that you tell your doctor if your child has ever had tuberculosis, or if your child has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Humira.
• Tuberculosis can develop during therapy even if your child has received treatment for the prevention of tuberculosis.
• If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Hepatitis B

• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV or if you think he/she might be at risk of getting HBV.
• Your doctor should test your child for HBV. In people who carry HBV, Humira can cause the virus to become active again.
• In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedure

• If your child is about to have surgery or dental procedures please inform your doctor that your child is taking Humira. Your doctor may recommend temporary discontinuation of Humira.

Demyelinating disease

• If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Humira. Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.

Vaccinations

• Certain vaccines may cause infections and should not be given while receiving Humira.

• Check with your doctor before your child receives any vaccines.
• It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
• If your child received Humira while she was pregnant, her baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child’s Humira use during her pregnancy so they can decide when her baby should receive any vaccine.

Heart failure

- If your child has mild heart failure and is being treated with Humira, his/her heart failure status must be closely monitored by your doctor. It is important to tell your doctor if your child has had or has a serious heart condition. If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Your doctor will decide if your child should receive Humira.

Fever, bruising, bleeding or looking pale

• In some patients the body may fail to produce enough of the blood cells that fight off infections or help your child to stop bleeding. Your doctor may decide to stop treatment. If your child develops a fever that does not go away, develops light bruises or bleeds very easily or looks very pale, call your doctor right away.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.

• People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
• If your child takes Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma, has been seen in patients taking Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine.
• Tell your doctor if your child is taking azathioprine or 6-mercaptopurine with Humira.
• Cases of non-melanoma skin cancer have been observed in patients taking Humira.
• If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

- There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.

Autoimmune disease

• On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and Humira

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Your child should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
• anakinra
• abatacept.

Humira can be taken together with:
• methotrexate
• certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations) • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

• Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
• Humira should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
• Humira can be used during breast-feeding.
• If your child received Humira during her pregnancy, her baby may have a higher risk for getting an infection.
• It is important that you tell her baby’s doctor and other health care professionals about her Humira use during her pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Humira may have a small effect on your child’s ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains polysorbate

This medicine contains 0.2 mg of polysorbate 80 in each 20 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if your child has any known allergies.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if your child needs a different dose.

Polyarticular juvenile idiopathic arthritis
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 2 years of age weighing 30 kg or more
40 mg every other week
Not applicable

Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
20 mg every other week
Not applicable

Enthesitis-related arthritis
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 years of age weighing 30 kg or more
40 mg every other week
Not applicable
Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
20 mg every other week
Not applicable

Paediatric plaque psoriasis
Age or body weight
How much and how often to take?
Notes
Children and adolescents from 4 to 17 years of age weighing 30 kg or more
First dose of 40 mg, followed by
40 mg one week later.

Thereafter, the usual dose is 40 mg every other week.
Not applicable
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg First dose of 20 mg, followed by 20 mg one week later.

Thereafter, the usual dose is 20 mg every other week.
Not applicable

Paediatric Crohn’s disease
Age or body weight
How much and how often to take?
Notes
Children and adolescents from 6 to 17 years of age weighing 40 kg or more

First dose of 80 mg, followed by
40 mg two weeks later.

If a faster response is required, your child’s doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later.

Thereafter, the usual dose is 40 mg every other week.
Your child’s doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents from 6 to 17 years of age weighing less than 40 kg
First dose of 40 mg, followed by
20 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week.
Your child’s doctor may increase the dose frequency to
20 mg every week.

Paediatric uveitis
Age or body weight
How much and how often to take?
Notes
Children and adolescents from
2 years of age weighing less than 30 kg

20 mg every other week
Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week.
Humira is recommended for use in combination with methotrexate.
Children and adolescents from
2 years of age weighing 30 kg or more

40 mg every other week
Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week.
Humira is recommended for use in combination with methotrexate.

Method and route of administration

Humira is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.

If you use more Humira than you should

If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that your child has taken more. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Humira

If you forget to give your child an injection, you should inject the next dose of Humira as soon as you remember. Then give your child’s next dose as you would have on the originally scheduled day, had you not forgotten a dose.

If you stop using Humira

The decision to stop using Humira should be discussed with your doctor. Your child’s symptoms may return if you stop using Humira.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection.

Tell your doctor immediately if you notice any of the following

• severe rash, hives or other signs of allergic reaction
• swollen face, hands, feet
• trouble breathing, swallowing
• shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible if you notice any of the following

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• arm or leg weakness a bump or open sore that doesn't heal
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness or itching)
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• rash
• musculoskeletal pain

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and influenza)
• intestinal infections (including gastroenteritis)
• skin infections (including cellulitis and shingles)
• ear infections
• oral infections (including tooth infections and cold sores)
• reproductive tract infections
• urinary tract infection
• fungal infections
• joint infections
• benign tumours
• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood swings (including depression)
• anxiety
• difficulty sleeping

• sensation disorders such as tingling, prickling or numbness
• migraine
• nerve root compression (including low back pain and leg pain)
• vision disturbances
• eye inflammation
• inflammation of the eye lid and eye swelling
• vertigo (feeling of dizziness or spinning)
• sensation of heart beating rapidly
• high blood pressure
• flushing
• haematoma (collection of blood outside of blood vessels)
• cough
• asthma
• shortness of breath
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, heart burn)
• acid reflux disease
• sicca syndrome (including dry eyes and dry mouth)
• itching
• itchy rash
• bruising
• inflammation of the skin (such as eczema)
• breaking of finger nails and toe nails
• increased sweating
• hair loss
• new onset or worsening of psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• oedema (swelling)
• fever
• reduction in blood platelets which increases risk of bleeding or bruising
• impaired healing

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer
• cancer that affects the lymph system
• melanoma
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (shaking)

• neuropathy (disorder of the nerves)
• stroke
• hearing loss, buzzing
• sensation of heart beating irregularly such as skipped beats
• heart problems that can cause shortness of breath or ankle swelling
• heart attack
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
• lung diseases causing shortness of breath (including inflammation)
• pulmonary embolism (blockage in an artery of the lung)
• pleural effusion (abnormal collection of fluid in the pleural space)
• inflammation of the pancreas which causes severe pain in the abdomen and back
• difficulty in swallowing
• facial oedema (swelling of the face)
• gallbladder inflammation, gallbladder stones
• fatty liver
• night sweats
• scar
• abnormal muscle breakdown
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
• sleep interruptions
• impotence
• inflammations

Rare (may affect up to 1 in 1,000 people)

• leukaemia (cancer affecting the blood and bone marrow)
• severe allergic reaction with shock
• multiple sclerosis
• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
• heart stops pumping
• pulmonary fibrosis (scarring of the lung)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
• facial oedema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory skin rash)
• lupus-like syndrome
• angioedema (localized swelling of the skin)
• lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
• Merkel cell carcinoma (a type of skin cancer)

• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
• liver failure
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• weight gain (for most patients, the weight gain was small)

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low blood measurements for white blood cells
• low blood measurements for red blood cells
• increased lipids in the blood
• elevated liver enzymes

Common (may affect up to 1 in 10 people)

• high blood measurements for white blood cells
• low blood measurements for platelets
• increased uric acid in the blood
• abnormal blood measurements for sodium
• low blood measurements for calcium
• low blood measurements for phosphate
• high blood sugar
• high blood measurements for lactate dehydrogenase
• autoantibodies present in the blood
• low blood potassium

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

• low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

Store in a refrigerator (2C – 8C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Humira contains

The active substance is adalimumab.
The other ingredients are mannitol, polysorbate 80 and water for injections.

What the Humira pre-filled syringe looks like and contents of the pack

Humira 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.2 ml solution.

The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.

The Humira pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol pads.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111
Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf.: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0
Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011
Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555
Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10
Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501
România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900
Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000
Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Suomi/Finland

Italia
AbbVie S.r.l.
Tel: +39 06 928921
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40
Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Injecting Humira

• The following instructions explain how to give your child a subcutaneous injection of Humira using the pre-filled syringe. First read all the instructions carefully and then follow them step by step.

• You will be instructed by your doctor, nurse or pharmacist on the technique of injection.

• Do not attempt to inject your child until you are sure that you understand how to prepare and give the injection.

• After proper training, the injection can be given by your child or given by another person, for example, a family member or friend.

• Only use each pre-filled syringe for one injection.

Humira Pre-filled Syringe

Plunger

Finger Grip
Needle Cover

Do not use the pre-filled syringe and call your doctor or pharmacist if the

• liquid is cloudy, discoloured, or has flakes or particles in it
• expiry (EXP) date has passed
• liquid has been frozen or left in direct sunlight
• pre-filled syringe has been dropped or crushed

Do not remove the needle cover until just before injection. Keep Humira out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the needle cover while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water STEP 2 Syringe

Pad
Check the expiry (EXP) date. Do not use the pre-filled syringe if expiry (EXP) date has passed.

Place the following on a clean, flat surface

• 1 single-use pre-filled syringe and
• 1 alcohol pad

Wash and dry your hands.
STEP 3
Choose an injection site:

• On the front of your child’s thighs or
• Your child’s belly (abdomen) at least 5 cm from his/her belly button (navel)
• At least 3 cm from your child’s last injection site

Wipe the injection site in a circular motion with the alcohol pad.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

Injectable Areas
Injectable Areas
STEP 4

Hold the pre-filled syringe in one hand.

Check the liquid in the pre-filled syringe.

• Make sure the liquid is clear and colourless
• Do not use the pre-filled syringe if the liquid is cloudy or has particles
• Do not use the pre-filled syringe if it has been dropped or crushed

Gently pull the needle cover straight off with the other hand.
Throw the needle cover away. Do not recap.

• Do not touch the needle with your fingers or let the needle touch anything

STEP 5
Hold the pre-filled syringe with the needle facing up.

• Hold the pre-filled syringe at eye level with one hand so you can see the air in the pre-filled syringe

Slowly push the plunger in to push the air out through the needle.

• It is normal to see a drop of liquid at the end of the needle

STEP 6
Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil.

Squeeze the skin at your child’s injection site with your other hand to make a raised area and hold it firmly.

45N a

STEP 7
Insert the needle all the way into the skin at about a
45-degree angle with one quick, short motion.

• After the needle is in, let go of the skin you are holding

Slowly push the plunger all the way in until all of the liquid is injected and the pre-filled syringe is empty.

STEP 8

Cotton Ball
When the injection is completed, slowly pull the needle out of the skin while keeping the pre-filled syringe at the same angle.

After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.

• Do not rub
• Slight bleeding at the injection site is normal

STEP 9

Throw away the used pre-filled syringe in a special disposal container as instructed by your doctor, nurse or pharmacist. Never recap a needle.

• Do not recycle or throw the pre-filled syringe in the household waste
• Always keep the pre-filled syringe and the special disposal container out of the sight and reach of children

The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.

Humira contains the active substance adalimumab.

Humira is used to treat
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Enthesitis-related arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
- Non-infectious uveitis

The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Humira should be used with methotrexate or alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.

Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Your doctor will decide if Humira should be used with methotrexate or alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.

Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.

Humira is used to treat psoriatic arthritis in adults. Humira can slow down the damage to the joints caused by the disease and can help them move more freely. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Plaque psoriasis

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.

Humira is used to treat
- moderate to severe chronic plaque psoriasis in adults and
- severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.

Hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Humira is used to treat
• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Humira is used to treat
- moderate to severe Crohn’s disease in adults and
- moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Humira is used to treat
• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat
- adults with non-infectious uveitis with inflammation affecting the back of the eye
- children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Do not use Humira:

• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

• If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.

• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Humira.

Allergic reactions

• If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

Infections

• If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor.

• You might get infections more easily while you are receiving Humira treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:
• tuberculosis
• infections caused by viruses, fungi, parasites or bacteria
• severe infection in the blood (sepsis)

In rare cases, these infections can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time.

• Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

• Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.

• If you are over 65 years you may be more likely to get infections while taking Humira. You and your doctor should pay special attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

• It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Humira.

• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.
• Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
• If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Hepatitis B

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.
• Your doctor should test you for HBV. In people who carry HBV, Humira can cause the virus to become active again.
• In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedure

• If you are about to have surgery or dental procedures, please inform your doctor that you are taking Humira. Your doctor may recommend temporary discontinuation of Humira.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Humira. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

• Certain vaccines may cause infections and should not be given while receiving Humira.

• Check with your doctor before you receive any vaccines.
• It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
• If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

• If you have mild heart failure and are being treated with Humira, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Humira.

Fever, bruising, bleeding or looking pale

• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.

• People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
• If you take Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma, has been seen in patients taking Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine.
• Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
• Cases of non-melanoma skin cancer have been observed in patients taking Humira.
• If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

- There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

• On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

• Vaccinations: if possible, children should be up to date with all vaccinations before using Humira.

Other medicines and Humira

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
- anakinra
- abatacept.

Humira can be taken together with:
• methotrexate
• certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations) • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
• Humira should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
• Humira can be used during breast-feeding.
• If you receive Humira during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby’s doctors and other health care professionals about your Humira use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Humira may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains polysorbate

This medicine contains 0.4 mg of polysorbate 80 in each 40 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if you need a different dose.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight How much and how often to take?
Notes
Adults
40 mg every other week
In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor decides that methotrexate is inappropriate, Humira can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give Humira 40 mg every week or 80 mg every other week.

Polyarticular juvenile idiopathic arthritis
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 2 years of age weighing 30 kg or more
40 mg every other week
Not applicable
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
20 mg every other week
Not applicable

Enthesitis-related arthritis
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 years of age weighing 30 kg or more
40 mg every other week
Not applicable
Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
20 mg every other week
Not applicable

Plaque psoriasis
Age or body weight
How much and how often to take?
Notes
Adults

First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week If you have an inadequate response, your doctor may increase the dosage to 40 mg

starting one week after the first dose.
every week or 80 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kg or more
First dose of 40 mg, followed by
40 mg one week later.

Thereafter, the usual dose is 40 mg every other week.
Not applicable
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg First dose of 20 mg, followed by 20 mg one week later.

Thereafter, the usual dose is 20 mg every other week.
Not applicable

Hidradenitis suppurativa
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (four 40 mg injections in one day or two
40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
It is recommended that you use an antiseptic wash daily on the affected areas.

Adolescents from 12 to 17 years of age weighing 30 kg or more
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 years of age weighing 40 kg or more
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by Your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg
First dose of 40 mg, followed by
20 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week.
Your doctor may increase the dose frequency to 20 mg every week.

Ulcerative colitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (four 40 mg injections in one day or two
40 mg injections per day for two consecutive days), followed by
80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
Your doctor may increase the dosage to 40 mg every week or
80 mg every other week.
Children and adolescents from 6 years of age weighing less than
40 kg
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.
Children and adolescents from 6 years of age weighing 40 kg or more
First dose of 160 mg (four 40 mg injections in one day or two
40 mg injections per day for two consecutive days), followed by
80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 80 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.
Corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Humira can also be given alone.
Children and adolescents from
2 years of age weighing less than 30 kg

20 mg every other week
Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week.
Humira is recommended for use in combination with methotrexate.
Children and adolescents from
2 years of age weighing at least
30 kg

40 mg every other week
Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week.
Humira is recommended for use in combination with methotrexate.

Method and route of administration

Humira is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.

If you use more Humira than you should

If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Humira

If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Humira

The decision to stop using Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection.

Tell your doctor immediately if you notice any of the following

• severe rash, hives or other signs of allergic reaction
• swollen face, hands, feet
• trouble breathing, swallowing
• shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible if you notice any of the following

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• arm or leg weakness
• a bump or open sore that doesn't heal
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness or itching)
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• rash
• musculoskeletal pain

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and influenza)
• intestinal infections (including gastroenteritis)
• skin infections (including cellulitis and shingles)
• ear infections
• oral infections (including tooth infections and cold sores)
• reproductive tract infections
• urinary tract infection
• fungal infections
• joint infections
• benign tumours

• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood swings (including depression)
• anxiety
• difficulty sleeping
• sensation disorders such as tingling, prickling or numbness
• migraine
• nerve root compression (including low back pain and leg pain)
• vision disturbances
• eye inflammation
• inflammation of the eye lid and eye swelling
• vertigo (feeling of dizziness or spinning)
• sensation of heart beating rapidly
• high blood pressure
• flushing
• haematoma (collection of blood outside of blood vessels)
• cough
• asthma
• shortness of breath
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, heart burn)
• acid reflux disease
• sicca syndrome (including dry eyes and dry mouth)
• itching
• itchy rash
• bruising
• inflammation of the skin (such as eczema)
• breaking of finger nails and toe nails
• increased sweating
• hair loss
• new onset or worsening of psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• oedema (swelling)
• fever
• reduction in blood platelets which increases risk of bleeding or bruising
• impaired healing

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer

• cancer that affects the lymph system
• melanoma
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (shaking)
• neuropathy (disorder of the nerves)
• stroke
• hearing loss, buzzing
• sensation of heart beating irregularly such as skipped beats
• heart problems that can cause shortness of breath or ankle swelling
• heart attack
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
• lung diseases causing shortness of breath (including inflammation)
• pulmonary embolism (blockage in an artery of the lung)
• pleural effusion (abnormal collection of fluid in the pleural space)
• inflammation of the pancreas which causes severe pain in the abdomen and back
• difficulty in swallowing
• facial oedema (swelling of the face)
• gallbladder inflammation, gallbladder stones
• fatty liver
• night sweats
• scar
• abnormal muscle breakdown
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
• sleep interruptions
• impotence
• inflammations

Rare (may affect up to 1 in 1,000 people)

• leukaemia (cancer affecting the blood and bone marrow)
• severe allergic reaction with shock
• multiple sclerosis
• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
• heart stops pumping
• pulmonary fibrosis (scarring of the lung)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
• facial oedema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory skin rash)
• lupus-like syndrome
• angioedema (localized swelling of the skin)
• lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
• liver failure
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• weight gain (for most patients, the weight gain was small)

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low blood measurements for white blood cells
• low blood measurements for red blood cells
• increased lipids in the blood
• elevated liver enzymes

Common (may affect up to 1 in 10 people)

• high blood measurements for white blood cells
• low blood measurements for platelets
• increased uric acid in the blood
• abnormal blood measurements for sodium
• low blood measurements for calcium
• low blood measurements for phosphate
• high blood sugar
• high blood measurements for lactate dehydrogenase
• autoantibodies present in the blood
• low blood potassium

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

• low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

Store in a refrigerator (2C – 8C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Humira contains

The active substance is adalimumab.
The other ingredients are mannitol, polysorbate 80 and water for injections.

What the Humira pre-filled syringe looks like and contents of the pack

Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution.

The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab. Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.

Not all pack sizes may be marketed.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023
България
АбВи ЕООД
Тел.:+359 2 90 30 430
Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600
Danmark
AbbVie A/S
Tlf.: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174
Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843
Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00
Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0
España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400
Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900
Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777
Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200
Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600
Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Injecting Humira

• The following instructions explain how to give yourself a subcutaneous injection of Humira using the pre-filled syringe. First read all the instructions carefully and then follow them step by step.

• You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.

• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

• After proper training, the injection can be given by yourself or given by another person, for example, a family member or friend.

• Only use each pre-filled syringe for one injection.

\
//
Humira Pre-filled Syringe

Plunger

Finger Grip
Needle Cover

Do not use the pre-filled syringe and call your doctor or pharmacist if the
- liquid is cloudy, discoloured, or has flakes or particles in it
- expiry (EXP) date has passed
- liquid has been frozen or left in direct sunlight
- pre-filled syringe has been dropped or crushed

Do not remove the needle cover until just before injection. Keep Humira out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the needle cover while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water STEP 2 Syringe

Pad
Check the expiry (EXP) date. Do not use the pre-filled syringe if expiry (EXP) date has passed.

Place the following on a clean, flat surface

• 1 single-use pre-filled syringe and
• 1 alcohol pad

Wash and dry your hands.

STEP 3

Injectable Areas

Injectable Areas
Choose an injection site:

• On the front of your thighs or
• Your belly (abdomen) at least 5 cm from your belly button (navel)
• At least 3 cm from your last injection site

Wipe the injection site in a circular motion with the alcohol pad.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

STEP 4

Hold the pre-filled syringe in one hand.

Check the liquid in the pre-filled syringe.

• Make sure the liquid is clear and colourless
• Do not use the pre-filled syringe if the liquid is cloudy or has particles
• Do not use the pre-filled syringe if it has been dropped or crushed

Gently pull the needle cover straight off with the other hand.
Throw the needle cover away. Do not recap.

• Do not touch the needle with your fingers or let the needle touch anything

STEP 5
Hold the pre-filled syringe with the needle facing up.

• Hold the pre-filled syringe at eye level with one hand so you can see the air in the pre-filled syringe

Slowly push the plunger in to push the air out through the needle.

• It is normal to see a drop of liquid at the end of the needle

45°
45°
STEP 6
Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil.

Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly.

STEP 7
Insert the needle all the way into the skin at about a 45- degree angle with one quick, short motion.

• After the needle is in, let go of the skin you are holding

Slowly push the plunger all the way in until all of the liquid is injected and the pre-filled syringe is empty.

STEP 8

Cotton Ball
When the injection is completed, slowly pull the needle out of the skin while keeping the pre-filled syringe at the same angle.

After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.

• Do not rub
• Slight bleeding at the injection site is normal

STEP 9

Throw away the used pre-filled syringe in a special disposal container as instructed by your doctor, nurse or pharmacist. Never recap a needle.

• Do not recycle or throw the pre-filled syringe in the household waste
• Always keep the pre-filled syringe and the special disposal container out of the sight and reach of children

The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.

Humira contains the active substance adalimumab.

Humira is used to treat
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Enthesitis-related arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
- Non-infectious uveitis

The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Humira should be used with methotrexate or alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.

Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Your doctor will decide if Humira should be used with methotrexate or alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.

Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.

Humira is used to treat psoriatic arthritis in adults. Humira can slow down the damage to the joints caused by the disease and can help them move more freely. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Plaque psoriasis

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.

Humira is used to treat
- moderate to severe chronic plaque psoriasis in adults and
- severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.

Hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Humira is used to treat
• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Humira is used to treat
- moderate to severe Crohn’s disease in adults and
- moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Humira is used to treat
• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat

• adults with non-infectious uveitis with inflammation affecting the back of the eye
• children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Do not use Humira:

• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

• If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.

• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Humira.

Allergic reactions

• If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

Infections

• If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor.

• You might get infections more easily while you are receiving Humira treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:
• tuberculosis
• infections caused by viruses, fungi, parasites or bacteria
• severe infection in the blood (sepsis)

In rare cases, these infections can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time.

• Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

• Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.

• If you are over 65 years you may be more likely to get infections while taking Humira. You and your doctor should pay special attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

• It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Humira.

• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.
• Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
• If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Hepatitis B

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.
• Your doctor should test you for HBV. In people who carry HBV, Humira can cause the virus to become active again.
• In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedure

• If you are about to have surgery or dental procedures, please inform your doctor that you are taking Humira. Your doctor may recommend temporary discontinuation of Humira.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Humira. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

• Certain vaccines may cause infections and should not be given while receiving Humira.

• Check with your doctor before you receive any vaccines.
• It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
• If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

• If you have mild heart failure and are being treated with Humira, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Humira.

Fever, bruising, bleeding or looking pale

• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.

• People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
• If you take Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma, has been seen in patients taking Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine.
• Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
• Cases of non-melanoma skin cancer have been observed in patients taking Humira.
• If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

- There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

• On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

• Vaccinations: if possible, children should be up to date with all vaccinations before using Humira.

Other medicines and Humira

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
- anakinra
- abatacept.

Humira can be taken together with:
• methotrexate
• certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations) • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
• Humira should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
• Humira can be used during breast-feeding.
• If you receive Humira during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby’s doctors and other health care professionals about your Humira use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Humira may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains polysorbate

This medicine contains 0.4 mg of polysorbate 80 in each 40 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Humira in each of the approved uses are shown in the following table.
Your doctor may prescribe another strength of Humira if you need a different dose.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight How much and how often to take?
Notes
Adults
40 mg every other week
In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor decides that methotrexate is inappropriate, Humira can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give Humira 40 mg every week or 80 mg every other week.

Polyarticular juvenile idiopathic arthritis
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 2 years of age weighing 30 kg or more
40 mg every other week
Not applicable
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
20 mg every other week
Not applicable

Enthesitis-related arthritis
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 years of age weighing 30 kg or more
40 mg every other week
Not applicable
Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
20 mg every other week
Not applicable

Plaque psoriasis
Age or body weight
How much and how often to take?
Notes
Adults

First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week If you have an inadequate response, your doctor may increase the dosage to 40 mg

starting one week after the first dose.
every week or 80 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kg or more
First dose of 40 mg, followed by
40 mg one week later.

Thereafter, the usual dose is 40 mg every other week.
Not applicable
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg First dose of 20 mg, followed by 20 mg one week later.

Thereafter, the usual dose is 20 mg every other week.
Not applicable

Hidradenitis suppurativa
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (four 40 mg injections in one day or two
40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
It is recommended that you use an antiseptic wash daily on the affected areas.

Adolescents from 12 to 17 years of age weighing 30 kg or more
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 years of age weighing 40 kg or more
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by Your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg
First dose of 40 mg, followed by
20 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week.
Your doctor may increase the dose frequency to 20 mg every week.

Ulcerative colitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (four 40 mg injections in one day or two
40 mg injections per day for two consecutive days), followed by
80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is
40 mg every other week.
Your doctor may increase the dosage to 40 mg every week or
80 mg every other week.
Children and adolescents from 6 years of age weighing less than
40 kg
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.
Children and adolescents from 6 years of age weighing 40 kg or more
First dose of 160 mg (four 40 mg injections in one day or two
40 mg injections per day for two consecutive days), followed by
80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 80 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.
Corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Humira can also be given alone.
Children and adolescents from
2 years of age weighing less than 30 kg

20 mg every other week
Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week.
Humira is recommended for use in combination with methotrexate.
Children and adolescents from
2 years of age weighing at least
30 kg

40 mg every other week
Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week.
Humira is recommended for use in combination with methotrexate.

Method and route of administration

Humira is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.

If you use more Humira than you should

If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Humira

If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Humira

The decision to stop using Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection.

Tell your doctor immediately if you notice any of the following

• severe rash, hives or other signs of allergic reaction
• swollen face, hands, feet
• trouble breathing, swallowing
• shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible if you notice any of the following

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• arm or leg weakness
• a bump or open sore that doesn't heal
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness or itching)
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• rash
• musculoskeletal pain

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and influenza)
• intestinal infections (including gastroenteritis)
• skin infections (including cellulitis and shingles)
• ear infections
• oral infections (including tooth infections and cold sores)
• reproductive tract infections
• urinary tract infection
• fungal infections
• joint infections
• benign tumours

• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood swings (including depression)
• anxiety
• difficulty sleeping
• sensation disorders such as tingling, prickling or numbness
• migraine
• nerve root compression (including low back pain and leg pain)
• vision disturbances
• eye inflammation
• inflammation of the eye lid and eye swelling
• vertigo (feeling of dizziness or spinning)
• sensation of heart beating rapidly
• high blood pressure
• flushing
• haematoma (collection of blood outside of blood vessels)
• cough
• asthma
• shortness of breath
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, heart burn)
• acid reflux disease
• sicca syndrome (including dry eyes and dry mouth)
• itching
• itchy rash
• bruising
• inflammation of the skin (such as eczema)
• breaking of finger nails and toe nails
• increased sweating
• hair loss
• new onset or worsening of psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• oedema (swelling)
• fever
• reduction in blood platelets which increases risk of bleeding or bruising
• impaired healing

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer

• cancer that affects the lymph system
• melanoma
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (shaking)
• neuropathy (disorder of the nerves)
• stroke
• hearing loss, buzzing
• sensation of heart beating irregularly such as skipped beats
• heart problems that can cause shortness of breath or ankle swelling
• heart attack
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
• lung diseases causing shortness of breath (including inflammation)
• pulmonary embolism (blockage in an artery of the lung)
• pleural effusion (abnormal collection of fluid in the pleural space)
• inflammation of the pancreas which causes severe pain in the abdomen and back
• difficulty in swallowing
• facial oedema (swelling of the face)
• gallbladder inflammation, gallbladder stones
• fatty liver
• night sweats
• scar
• abnormal muscle breakdown
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
• sleep interruptions
• impotence
• inflammations

Rare (may affect up to 1 in 1,000 people)

• leukaemia (cancer affecting the blood and bone marrow)
• severe allergic reaction with shock
• multiple sclerosis
• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
• heart stops pumping
• pulmonary fibrosis (scarring of the lung)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
• facial oedema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory skin rash)
• lupus-like syndrome
• angioedema (localized swelling of the skin)
• lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
• liver failure
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• weight gain (for most patients, the weight gain was small)

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low blood measurements for white blood cells
• low blood measurements for red blood cells
• increased lipids in the blood
• elevated liver enzymes

Common (may affect up to 1 in 10 people)

• high blood measurements for white blood cells
• low blood measurements for platelets
• increased uric acid in the blood
• abnormal blood measurements for sodium
• low blood measurements for calcium
• low blood measurements for phosphate
• high blood sugar
• high blood measurements for lactate dehydrogenase
• autoantibodies present in the blood
• low blood potassium

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

• low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

Store in a refrigerator (2C – 8C). Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when you are travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator.

You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Humira contains

The active substance is adalimumab.
The other ingredients are mannitol, polysorbate 80 and water for injections.

What the Humira pre-filled pen looks like and contents of the pack

Humira 40 mg solution for injection in pre-filled pen is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution.

The Humira pre-filled pen is a single-use grey and plum-coloured pen which contains a glass syringe with Humira. There are two caps – one is grey and labelled ‘1’ and the other is plum and labelled ‘2’. There is a window on each side of the pen through which you can see the Humira solution inside the syringe.

The Humira pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens. The 1 pre-filled pen pack comes with 2 alcohol pads (1 spare). For the 2, 4 and 6 pre-filled pen packs, each pre-filled pen comes with 1 alcohol pad.

Not all pack sizes may be marketed.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023
България
АбВи ЕООД
Тел.:+359 2 90 30 430
Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600
Danmark
AbbVie A/S
Tlf.: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174
Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843
Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00
Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555
Österreich
AbbVie GmbH
Tel: +43 1 20589-0
España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400
Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060
Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777
Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200
Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600
Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Injecting Humira

• The following instructions explain how to give yourself a subcutaneous injection of Humira using the pre-filled pen. First read all the instructions carefully and then follow them step by step.

• You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.

• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

• After proper training, the injection can be given by yourself or given by another person, for example, a family member or friend.

• Only use each pre-filled pen for one injection.

SE
Humira Pre-filled Pen

Grey Cap 1 White Needle Sleeve White Arrow Plum-coloured Cap 2

Needle Inspection Window Plum Activator Button

Do not use the pre-filled pen and call your doctor or pharmacist if the

• liquid is cloudy, discoloured, or has flakes or particles in it
• expiry (EXP) date has passed
• liquid has been frozen or left in direct sunlight
• pre-filled pen has been dropped or crushed

Do not remove the caps until just before injection. Keep Humira out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the Grey or Plum-coloured Caps while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water

'a
STEP 2

Pen

Pad

Check expiry (EXP) date. Do not use the pre-filled pen if expiry (EXP) date has passed.

Place the following on a clean, flat surface

• 1 single-use pre-filled pen and
• 1 alcohol pad

Wash and dry your hands.
STEP 3

Injectable Areas

Injectable Areas

Choose an injection site:

• On the front of your thighs or
• Your belly (abdomen) at least 5 cm from your belly button (navel)
• At least 3 cm from your last injection site

Wipe the injection site in a circular motion with the alcohol pad.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

STEP 4

Hold the pre-filled pen with the Grey Cap 1 pointing up.

Check the inspection window.

- It is normal to see 1 or more bubbles in the window
- Make sure the liquid is clear and colourless
- Do not use the pre-filled pen if the liquid is cloudy or has particles
- Do not use the pre-filled pen if it has been dropped or crushed
STEP 5

Cap 1

Cap 2

Pull the Grey Cap 1 straight off. Throw the cap away. Do not recap.

• Check that the small black needle cover of the syringe has been removed with the cap
• It is normal to see a few drops of liquid come out of the needle

Pull the Plum-coloured Cap 2 straight off. Throw the cap away. Do not recap.

The pre-filled pen is now ready to use.

Turn the pre-filled pen so that the white arrow points toward the injection site.
STEP 6

Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly until the injection is complete.

Point the white arrow toward the injection site (thigh or abdomen).

Place the white needle sleeve straight (90˚ angle) against the injection site.

Hold the pre-filled pen so that you can see the inspection window.

Do not press the plum activator button until you are ready to inject.

S
STEP 7

10 Seconds

Firmly push the pre-filled pen down against the injection site before starting the injection.
Keep pushing down to prevent the pre-filled pen from moving away from the skin during the injection.

Press the plum activator button and count slowly for 10 seconds.

• A loud “click” will signal the start of the injection
• Keep pushing the pre-filled pen down firmly against the injection site until the injection is complete.

The injection is complete when the yellow indicator has stopped moving.
STEP 8

When the injection is completed, slowly pull the pre-filled pen from the skin. The white needle sleeve will cover the needle tip.
- A small amount of liquid on the injection site is normal

If there are more than a few drops of liquid on the injection site, contact your doctor, nurse or pharmacist.

After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.

- Do not rub
- Slight bleeding at the injection site is normal
STEP 9

Throw away the used pre-filled pen in a special disposal container as instructed by your doctor, nurse or pharmacist.

• Do not recycle or throw the pre-filled pen in the household waste
• Always keep the pre-filled pen and the special disposal container out of the sight and reach of children

The caps, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.

Humira contains the active substance adalimumab.

Humira is used to treat
- Rheumatoid arthritis
- Plaque psoriasis
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
- Non-infectious uveitis

The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Humira should be used with methotrexate or alone.

Plaque psoriasis

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.

Humira is used to treat moderate to severe chronic plaque psoriasis in adults.

Hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Humira is used to treat
- moderate to severe hidradenitis suppurativa in adults and
- moderate to severe hidradenitis suppurativa in adolescents aged 12to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Humira is used to treat
- moderate to severe Crohn’s disease in adults and
- moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Humira is used to treat
• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat
- adults with non-infectious uveitis with inflammation affecting the back of the eye
- children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Do not use Humira:

• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

• If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.

• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Humira.

Allergic reactions

• If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

Infections

• If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor.

• You might get infections more easily while you are receiving Humira treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:
• tuberculosis

• infections caused by viruses, fungi, parasites or bacteria
• severe infection in the blood (sepsis)

In rare cases, these infections can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time.

• Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

• Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.

• If you are over 65 years you may be more likely to get infections while taking Humira. You and your doctor should pay special attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

• It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Humira.

• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.
• Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
• If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Hepatitis B

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.

• Your doctor should test you for HBV. In people who carry HBV, Humira can cause the virus to become active again.
• In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedure

• If you are about to have surgery or dental procedures, please inform your doctor that you are taking Humira. Your doctor may recommend temporary discontinuation of Humira.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Humira. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

• Certain vaccines may cause infections and should not be given while receiving Humira.

• Check with your doctor before you receive any vaccines.
• It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
• If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

• If you have mild heart failure and are being treated with Humira, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Humira.

Fever, bruising, bleeding or looking pale

• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.

• People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
• If you take Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine.
• Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
• Cases of non-melanoma skin cancer have been observed in patients taking Humira.
• If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

- There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

• On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

• Vaccinations: if possible, children should be up to date with all vaccinations before using Humira.

Other medicines and Humira

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
- anakinra
- abatacept.

Humira can be taken together with:
• methotrexate
• certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations) • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
• Humira should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
• Humira can be used during breast-feeding.
• If you receive Humira during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby’s doctors and other health care professionals about your Humira use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Humira may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains polysorbate

This medicine contains 0.8 mg of polysorbate 80 in each 80 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if you need a different dose.

Rheumatoid arthritis
Age or body weight
How much and how often to take?
Notes
Adults
40 mg every other week
In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor decides that methotrexate is inappropriate, Humira can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give Humira 40 mg every week or 80 mg every other week.

Plaque psoriasis
Age or body weight
How much and how often to take?
Notes
Adults

First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
If you have an inadequate response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Hidradenitis suppurativa
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (two
80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
It is recommended that you use an antiseptic wash daily on the affected areas.

Adolescents from 12 to 17 years of age weighing 30 kg or more
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week later.
If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 years of age weighing 40 kg or more
First dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later.

Thereafter, the usual dose is
40 mg every other week.
Your doctor may increase the dosage to 40 mg every week or
80 mg every other week.

Children and adolescents from 6 to 17 years of age weighing less than 40 kg
First dose of 40 mg, followed by
20 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.

Thereafter, the usual dose is
20 mg every other week.
Your doctor may increase the dose frequency to 20 mg every week.

Ulcerative colitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (two
80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later.

Thereafter, the usual dose is
40 mg every other week.
Your doctor may increase the dosage to 40 mg every week or
80 mg every other week.
Children and adolescents from 6 years of age weighing less than
40 kg
First dose of 80 mg (one 80 mg injection), followed by 40 mg
(one 40 mg injection) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.
Children and adolescents from 6 years of age weighing 40 kg or more
First dose of 160 mg (two 80 mg injections in one day or one
80 mg injection per day for two consecutive days), followed by
80 mg (one 80 mg injection) two weeks later.

Thereafter, the usual dose is 80 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
Corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Humira can also be given alone.
Children and adolescents from
2 years of age weighing less than 30 kg

20 mg every other week
Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of

20 mg every other week.
Humira is recommended for use in combination with methotrexate.
Children and adolescents from
2 years of age weighing 30 kg or more

40 mg every other week
Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week.
Humira is recommended for use in combination with methotrexate.

Method and route of administration

Humira is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.

If you use more Humira than you should

If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Humira

If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Humira

The decision to stop using Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection.

Tell your doctor immediately if you notice any of the following

• severe rash, hives or other signs of allergic reaction
• swollen face, hands, feet
• trouble breathing, swallowing
• shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible if you notice any of the following

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• arm or leg weakness
• a bump or open sore that doesn't heal
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness or itching)
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• rash
• musculoskeletal pain

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and influenza)
• intestinal infections (including gastroenteritis)
• skin infections (including cellulitis and shingles)
• ear infections
• oral infections (including tooth infections and cold sores)
• reproductive tract infections
• urinary tract infection
• fungal infections
• joint infections
• benign tumours
• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood swings (including depression)
• anxiety
• difficulty sleeping
• sensation disorders such as tingling, prickling or numbness
• migraine
• nerve root compression (including low back pain and leg pain)
• vision disturbances
• eye inflammation
• inflammation of the eye lid and eye swelling
• vertigo (feeling of dizziness or spinning)

• sensation of heart beating rapidly
• high blood pressure
• flushing
• haematoma (collection of blood outside of blood vessels)
• cough
• asthma
• shortness of breath
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, heart burn)
• acid reflux disease
• sicca syndrome (including dry eyes and dry mouth)
• itching
• itchy rash
• bruising
• inflammation of the skin (such as eczema)
• breaking of finger nails and toe nails
• increased sweating
• hair loss
• new onset or worsening of psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• oedema (swelling)
• fever
• reduction in blood platelets which increases risk of bleeding or bruising
• impaired healing

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer
• cancer that affects the lymph system
• melanoma
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (shaking)
• neuropathy (disorder of the nerves)
• stroke
• hearing loss, buzzing
• sensation of heart beating irregularly such as skipped beats
• heart problems that can cause shortness of breath or ankle swelling
• heart attack
• a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel

• lung diseases causing shortness of breath (including inflammation)
• pulmonary embolism (blockage in an artery of the lung)
• pleural effusion (abnormal collection of fluid in the pleural space)
• inflammation of the pancreas which causes severe pain in the abdomen and back
• difficulty in swallowing
• facial oedema (swelling of the face)
• gallbladder inflammation, gallbladder stones
• fatty liver
• night sweats
• scar
• abnormal muscle breakdown
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
• sleep interruptions
• impotence
• inflammations

Rare (may affect up to 1 in 1,000 people)

• leukaemia (cancer affecting the blood and bone marrow)
• severe allergic reaction with shock
• multiple sclerosis
• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
• heart stops pumping
• pulmonary fibrosis (scarring of the lung)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
• facial oedema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory skin rash)
• lupus-like syndrome
• angioedema (localized swelling of the skin)
• lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
• liver failure
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• weight gain (for most patients, the weight gain was small)

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low blood measurements for white blood cells
• low blood measurements for red blood cells
• increased lipids in the blood
• elevated liver enzymes

Common (may affect up to 1 in 10 people)

• high blood measurements for white blood cells
• low blood measurements for platelets
• increased uric acid in the blood
• abnormal blood measurements for sodium
• low blood measurements for calcium
• low blood measurements for phosphate
• high blood sugar
• high blood measurements for lactate dehydrogenase
• autoantibodies present in the blood
• low blood potassium

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

• low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

Store in a refrigerator (2C – 8C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Humira contains

The active substance is adalimumab.
The other ingredients are mannitol, polysorbate 80 and water for injections.

What the Humira pre-filled syringe looks like and contents of the pack

Humira 80 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml solution.

The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.

The Humira pre-filled syringe is available in a pack containing 1 pre-filled syringe for patient use with 1 alcohol pad.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430
Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600
Danmark
AbbVie A/S
Tlf.: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174
Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843
Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00
Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0
España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400
Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35
Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060
Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777
Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200
Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40
Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Injecting Humira

• The following instructions explain how to give yourself a subcutaneous injection of Humira using the pre-filled syringe. First read all the instructions carefully and then follow them step by step.

• You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.

• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

• After proper training, the injection can be given by yourself or given by another person, for example, a family member or friend.

• Only use each pre-filled syringe for one injection.

Humira Pre-filled Syringe

Plunger

Finger Grip
Needle Cover

Do not use the pre-filled syringe and call your doctor or pharmacist if the
- liquid is cloudy, discoloured, or has flakes or particles in it
- expiry (EXP) date has passed
- liquid has been frozen or left in direct sunlight
- pre-filled syringe has been dropped or crushed

~
~
✓;
Do not remove the needle cover until just before injection. Keep Humira out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the needle cover while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water STEP 2 Syringe

Pad
Check the expiry (EXP) date. Do not use the pre-filled syringe if expiry (EXP) date has passed.

Place the following on a clean, flat surface

• 1 single-use pre-filled syringe and
• 1 alcohol pad

Wash and dry your hands.
STEP 3

Injectable Areas

Injectable Areas
Choose an injection site:

• On the front of your thighs or
• Your belly (abdomen) at least 5 cm from your belly button (navel)
• At least 3 cm from your last injection site

Wipe the injection site in a circular motion with the alcohol pad.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

STEP 4

Hold the pre-filled syringe in one hand.

Check the liquid in the pre-filled syringe.

• Make sure the liquid is clear and colourless
• Do not use the pre-filled syringe if the liquid is cloudy or has particles
• Do not use the pre-filled syringe if it has been dropped or crushed

Gently pull the needle cover straight off with the other hand.
Throw the needle cover away. Do not recap.

• Do not touch the needle with your fingers or let the needle touch anything

STEP 5
Hold the pre-filled syringe with the needle facing up.

• Hold the pre-filled syringe at eye level with one hand so you can see the air in the pre-filled syringe

Slowly push the plunger in to push the air out through the needle.

• It is normal to see a drop of liquid at the end of the needle

STEP 6
Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil.

Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly.

45°
STEP 7
Insert the needle all the way into the skin at about a 45- degree angle with one quick, short motion.

• After the needle is in, let go of the skin you are holding

Slowly push the plunger all the way in until all of the liquid is injected and the pre-filled syringe is empty.

STEP 8

Cotton Ball
When the injection is completed, slowly pull the needle out of the skin while keeping the pre-filled syringe at the same angle.

After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.

• Do not rub
• Slight bleeding at the injection site is normal

STEP 9

Throw away the used pre-filled syringe in a special disposal container as instructed by your doctor, nurse or pharmacist. Never recap a needle.

• Do not recycle or throw the pre-filled syringe in the household waste
• Always keep the pre-filled syringe and the special disposal container out of the sight and reach of children

The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.

Humira contains the active substance adalimumab.

Humira is used to treat
- Rheumatoid arthritis
- Plaque psoriasis
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
- Non-infectious uveitis

The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Humira should be used with methotrexate or alone.

Plaque psoriasis

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.

Humira is used to treat moderate to severe chronic plaque psoriasis in adults.

Hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Humira is used to treat
• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Humira is used to treat
- moderate to severe Crohn’s disease in adults and
- moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Humira is used to treat
• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat
- adults with non-infectious uveitis with inflammation affecting the back of the eye
- children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.

Do not use Humira:

• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

• If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.

• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Humira.

Allergic reactions

• If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

Infections

• If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor.

• You might get infections more easily while you are receiving Humira treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:
• tuberculosis

• infections caused by viruses, fungi, parasites or bacteria
• severe infection in the blood (sepsis)

In rare cases, these infections can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time.

• Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.

• Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.

• If you are over 65 years you may be more likely to get infections while taking Humira. You and your doctor should pay special attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

• It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Humira.

• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.
• Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
• If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Hepatitis B

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.
• Your doctor should test you for HBV. In people who carry HBV, Humira can cause the virus to become active again.
• In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedure

• If you are about to have surgery or dental procedures please inform your doctor that you are taking Humira. Your doctor may recommend temporary discontinuation of Humira.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Humira. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

• Certain vaccines may cause infections and should not be given while receiving Humira.

• Check with your doctor before you receive any vaccines.
• It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
• If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

• If you have mild heart failure and are being treated with Humira, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Humira.

Fever, bruising, bleeding or looking pale

• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.

• People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
• If you take Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma, has been seen in patients taking Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine.
• Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
• Cases of non-melanoma skin cancer have been observed in patients taking Humira.
• If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

- There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

• On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

• Vaccinations: if possible, children should be up to date with all vaccinations before using Humira.

Other medicines and Humira

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
- anakinra
- abatacept.

Humira can be taken together with:
- methotrexate
- certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
- steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
• Humira should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
• Humira can be used during breast-feeding.
• If you receive Humira during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby’s doctors and other health care professionals about your Humira use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Humira may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains polysorbate

This medicine contains 0.8 mg of polysorbate 80 in each 80 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if you need a different dose.

Rheumatoid arthritis
Age or body weight
How much and how often to take?
Notes
Adults
40 mg every other week
In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor decides that methotrexate is inappropriate, Humira can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give Humira 40 mg every week or 80 mg every other week.

Plaque psoriasis
Age or body weight
How much and how often to take?
Notes
Adults

First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
If you have an inadequate response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Hidradenitis suppurativa
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (two 80 mg injections in one day or one
80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later. After two further weeks, continue with a dose of 40 mg every It is recommended that you use an antiseptic wash daily on the affected areas.

week or 80 mg every other week, as prescribed by your doctor.
Adolescents from 12 to 17 years of age weighing 30 kg or more
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week later.
If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 to 17 years of age weighing 40 kg or more First dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.

If a faster response is required, the doctor may prescribe a first dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
Your doctor may increase the dosage to 40 mg every week or
80 mg every other week.

Children and adolescents from 6 to 17 years of age weighing less than 40 kg
First dose of 40 mg, followed by
20 mg two weeks later.
If a faster response is required, the doctor may prescribe a first dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week.
Your doctor may increase the dose frequency to 20 mg every week.

Ulcerative colitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (two 80 mg injections in one day or one
80 mg injection per day for two consecutive days), followed by
80 mg (one 80 mg injection) two weeks later.

Your doctor may increase the dosage to 40 mg every week or
80 mg every other week.

Thereafter, the usual dose is 40 mg every other week.

Children and adolescents from 6 years of age weighing less than
40 kg
First dose of 80 mg (one 80 mg injection), followed by 40 mg
(one 40 mg injection) two weeks later.

Thereafter, the usual dose is 40 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.
Children and adolescents from 6 years of age weighing 40 kg or more
First dose of 160 mg (two 80 mg injections in one day or one
80 mg injection per day for two consecutive days), followed by
80 mg (one 80 mg injection) two weeks later.

Thereafter, the usual dose is 80 mg every other week.
You should continue taking
Humira at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
Corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Humira can also be given alone.
Children and adolescents from
2 years of age weighing less than 30 kg

20 mg every other week
Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week.
Humira is recommended for use in combination with methotrexate.
Children and adolescents from
2 years of age weighing 30 kg or more

40 mg every other week
Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week.
Humira is recommended for use in combination with methotrexate.

Method and route of administration

Humira is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.

If you use more Humira than you should

If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Humira

If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Humira

The decision to stop using Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection.

Tell your doctor immediately if you notice any of the following

• severe rash, hives or other signs of allergic reaction
• swollen face, hands, feet
• trouble breathing, swallowing
• shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible if you notice any of the following

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• arm or leg weakness
• a bump or open sore that doesn't heal
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.

Very common (may affect more than 1 in 10 people)

• injection site reactions (including pain, swelling, redness or itching)

• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• rash
• musculoskeletal pain

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and influenza)
• intestinal infections (including gastroenteritis)
• skin infections (including cellulitis and shingles)
• ear infections
• oral infections (including tooth infections and cold sores)
• reproductive tract infections
• urinary tract infection
• fungal infections
• joint infections
• benign tumours
• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood swings (including depression)
• anxiety
• difficulty sleeping
• sensation disorders such as tingling, prickling or numbness
• migraine
• nerve root compression (including low back pain and leg pain)
• vision disturbances
• eye inflammation
• inflammation of the eye lid and eye swelling
• vertigo (feeling of dizziness or spinning)
• sensation of heart beating rapidly
• high blood pressure
• flushing
• haematoma (collection of blood outside of blood vessels)
• cough
• asthma
• shortness of breath
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, heart burn)
• acid reflux disease
• sicca syndrome (including dry eyes and dry mouth)
• itching
• itchy rash
• bruising
• inflammation of the skin (such as eczema)
• breaking of finger nails and toe nails
• increased sweating
• hair loss

• new onset or worsening of psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• oedema (swelling)
• fever
• reduction in blood platelets which increases risk of bleeding or bruising
• impaired healing

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer
• cancer that affects the lymph system
• melanoma
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (shaking)
• neuropathy (disorder of the nerves)
• stroke
• hearing loss, buzzing
• sensation of heart beating irregularly such as skipped beats
• heart problems that can cause shortness of breath or ankle swelling
• heart attack
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
• lung diseases causing shortness of breath (including inflammation)
• pulmonary embolism (blockage in an artery of the lung)
• pleural effusion (abnormal collection of fluid in the pleural space)
• inflammation of the pancreas which causes severe pain in the abdomen and back
• difficulty in swallowing
• facial oedema (swelling of the face)
• gallbladder inflammation, gallbladder stones
• fatty liver
• night sweats
• scar
• abnormal muscle breakdown
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
• sleep interruptions
• impotence
• inflammations

Rare (may affect up to 1 in 1,000 people)

• leukaemia (cancer affecting the blood and bone marrow)
• severe allergic reaction with shock
• multiple sclerosis
• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
• heart stops pumping
• pulmonary fibrosis (scarring of the lung)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
• facial oedema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory skin rash)
• lupus-like syndrome
• angioedema (localized swelling of the skin)
• lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
• liver failure
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• weight gain (for most patients, the weight gain was small)

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

• low blood measurements for white blood cells
• low blood measurements for red blood cells
• increased lipids in the blood
• elevated liver enzymes

Common (may affect up to 1 in 10 people)

• high blood measurements for white blood cells
• low blood measurements for platelets
• increased uric acid in the blood
• abnormal blood measurements for sodium
• low blood measurements for calcium
• low blood measurements for phosphate
• high blood sugar
• high blood measurements for lactate dehydrogenase

• autoantibodies present in the blood
• low blood potassium

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

• low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

Store in a refrigerator (2C – 8C). Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when you are travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator.

You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Humira contains

The active substance is adalimumab.
The other ingredients are mannitol, polysorbate 80 and water for injections.

What the Humira pre-filled pen looks like and contents of the pack

Humira 80 mg solution for injection in pre-filled pen is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml solution.

The Humira pre-filled pen is a single-use grey and plum-coloured pen which contains a glass syringe with Humira. There are two caps – one is grey and labelled ‘1’ and the other is plum and labelled ‘2’. There is a window on each side of the pen through which you can see the Humira solution inside the syringe.

The Humira pre-filled pen is available in packs containing:
• 1 pre-filled pen for patient use with 2 alcohol pads (1 spare)
• 3 pre-filled pens for patient use with 4 alcohol pads (1 spare)

Not all pack sizes may be marketed.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023
България
АбВи ЕООД
Тел.:+359 2 90 30 430
Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600
Danmark
AbbVie A/S
Tlf.: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843
Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00
Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555
Österreich
AbbVie GmbH
Tel: +43 1 20589-0
España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400
Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35
Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060
Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777
Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200
Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600
Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

Ea

7.
Injecting Humira

• The following instructions explain how to give yourself a subcutaneous injection of Humira using the pre-filled pen. First read all the instructions carefully and then follow them step by step.

• You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.

• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

• After proper training, the injection can be given by yourself or given by another person, for example, a family member or friend.

• Only use each pre-filled pen for one injection.

Humira Pre-filled Pen

Grey Cap 1 White Needle Sleeve White Arrow Plum-coloured Cap 2

Needle Inspection Window Plum Activator Button

Do not use the pre-filled pen and call your doctor or pharmacist if the

• liquid is cloudy, discoloured, or has flakes or particles in it
• expiry (EXP) date has passed
• liquid has been frozen or left in direct sunlight
• pre-filled pen has been dropped or crushed

Do not remove the caps until just before injection. Keep Humira out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the Grey or Plum-coloured Caps while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water

'a
STEP 2

Pen

Pad

Check expiry (EXP) date. Do not use the pre-filled pen if expiry (EXP) date has passed.

Place the following on a clean, flat surface

• 1 single-use pre-filled pen and
• 1 alcohol pad

Wash and dry your hands.
STEP 3

Injectable Areas

Injectable Areas

Choose an injection site:

• On the front of your thighs or
• Your belly (abdomen) at least 5 cm from your belly button (navel)
• At least 3 cm from your last injection site

Wipe the injection site in a circular motion with the alcohol pad.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

STEP 4

Hold the pre-filled pen with the Grey Cap 1 pointing up.

Check the inspection window.

- It is normal to see 1 or more bubbles in the window
- Make sure the liquid is clear and colourless
- Do not use the pre-filled pen if the liquid is cloudy or has particles
- Do not use the pre-filled pen if it has been dropped or crushed
STEP 5

Cap 1

Cap 2

Pull the Grey Cap 1 straight off. Throw the cap away. Do not recap.

• Check that the small black needle cover of the syringe has been removed with the cap
• It is normal to see a few drops of liquid come out of the needle

Pull the Plum-coloured Cap 2 straight off. Throw the cap away. Do not recap.

The pre-filled pen is now ready to use.

Turn the pre-filled pen so that the white arrow points toward the injection site.
STEP 6

Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly until the injection is complete.

Point the white arrow toward the injection site (thigh or abdomen).

Place the white needle sleeve straight (90˚ angle) against the injection site.

Hold the pre-filled pen so that you can see the inspection window.

Do not press the plum activator button until you are ready to inject.

STEP 7

15 Seconds

Firmly push the pre-filled pen down against the injection site before starting the injection.
Keep pushing down to prevent the pre-filled pen from moving away from the skin during the injection.

Press the plum activator button and count slowly for 15 seconds.

• A loud “click” will signal the start of the injection
• Keep pushing the pre-filled pen down firmly against the injection site until the injection is complete.

The injection is complete when the yellow indicator has stopped moving.
STEP 8

When the injection is completed, slowly pull the pre-filled pen from the skin. The white needle sleeve will cover the needle tip.
- A small amount of liquid on the injection site is normal

If there are more than a few drops of liquid on the injection site, contact your doctor, nurse or pharmacist.

After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.

- Do not rub
- Slight bleeding at the injection site is normal
STEP 9

Throw away the used pre-filled pen in a special disposal container as instructed by your doctor, nurse or pharmacist.

• Do not recycle or throw the pre-filled pen in the household waste
• Always keep the pre-filled pen and the special disposal container out of the sight and reach of children

The caps, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.