secukinumab: package leaflet

persons sensitive to this substance.

it may not be safe for you to use.

needle cap.

7.
Be careful not to touch the syringe guard wings before use. By touching them, the syringe guard may be activated too early.
8.
Do not remove the needle cap until just before you give the injection.
9.
The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps container.

Needle cap
Viewing window
Label & expiry date
Syringe Guard
Syringe guard wings
Finger grips
Plunger
Plunger head

Storage of the Cosentyx 75 mg pre-filled syringe
1.
Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator between 2°C and 8°C. DO NOT FREEZE.
2.
Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
3.
Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”. If it has expired, return the entire pack to the pharmacy.

The injection site

The injection site is the place on the body where you are going to use the syringe.
- The recommended site is the front of your thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
- Choose a different site each time you give yourself an injection.
- Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

If a caregiver is giving you the injection, the outer upper arms may also be used.

Preparing the Cosentyx 75 mg pre-filled syringe ready for use
1.
Take the box containing the syringe out of the refrigerator and leave it unopened for about 15-30 minutes so that it reaches room temperature.
2.
When you are ready to use the syringe, wash your hands thoroughly with soap and water.
3.
Clean the injection site with an alcohol swab.
4.
Remove the syringe from the outer box and take it out of the blister by holding the syringe guard body.
5.
Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken.
In all these cases, return the entire product pack to the pharmacy.

How to use the Cosentyx 75 mg pre-filled syringe

Carefully remove the needle cap from the syringe by holding the syringe guard body.
Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.

Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in at an angle of approximately 45 degrees to ensure that the medicine can be fully administered.
Hold the syringe as shown. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.

Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Disposal instructions

Dispose of the used syringe in a sharps container
(closable, puncture resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.

persons sensitive to this substance.

it may not be safe for you to use.

needle cap.

7.
Be careful not to touch the syringe guard wings before use. By touching them, the syringe guard may be activated too early.
8.
Do not remove the needle cap until just before you give the injection.
9.
The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps container.

Needle cap
Syringe guard
Viewing window, label & expiry date
Finger grips
Syringe guard wings
Plunger
Plunger head

Storage of the Cosentyx 150 mg pre-filled syringe
1.
Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator between 2°C and 8°C. DO NOT FREEZE.
2.
Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
3.
Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”. If it has expired, return the entire pack to the pharmacy.

The injection site

The injection site is the place on the body where you are going to use the syringe.
- The recommended site is the front of your thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
- Choose a different site each time you give yourself an injection.
- Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

If a caregiver is giving you the injection, the outer upper arms may also be used.

Preparing the Cosentyx 150 mg pre-filled syringe ready for use
Note: For a 150 mg dose, prepare 1 pre-filled syringe and inject the content. For a 300 mg dose, prepare 2 pre-filled syringes and inject the contents of both.
1.
Take the box containing the syringe out of the refrigerator and leave it unopened for about 15-30 minutes so that it reaches room temperature.
2.
When you are ready to use the syringe, wash your hands thoroughly with soap and water.
3.
Clean the injection site with an alcohol swab.
4.
Remove the syringe from the outer box and take it out of the blister by holding the syringe guard body.
5.
Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken.
In all these cases, return the entire product pack to the pharmacy.

How to use the Cosentyx 150 mg pre-filled syringe

Carefully remove the needle cap from the syringe by holding the syringe guard body.
Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.

Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in to ensure that the medicine can be fully administered.

Hold the syringe as shown. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.

Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Disposal instructions

Dispose of the used syringe in a sharps container
(closable, puncture resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis.

Cosentyx is used for the treatment of the following inflammatory diseases:
- Plaque psoriasis
- Hidradenitis suppurativa
- Psoriatic arthritis
- Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis
- Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Plaque psoriasis
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque psoriasis.

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.

Hidradenitis suppurativa
Cosentyx is used to treat a condition called hidradenitis suppurativa, also sometimes called acne inversa or Verneuil’s disease. This condition is a chronic and painful inflammatory skin disease.
Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It 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.

Cosentyx can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. If you have hidradenitis suppurativa you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx.

Cosentyx is used in adults with hidradenitis suppurativa and can be used alone or with antibiotics.

Psoriatic arthritis
Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and slow down the damage to the cartilage and bone of the joints involved in the disease.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate.

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to do normal daily activities.

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation and improve your physical function.

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial spondyloarthritis.

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit you by reducing the signs and symptoms of your disease and improving your physical function.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis Cosentyx is used in patients (6 years of age and older) to treat conditions of the juvenile idiopathic arthritis categories called “enthesitis-related arthritis” and “juvenile psoriatic arthritis”. These conditions are inflammatory diseases affecting the joints and the places where tendons join the bone.

Using Cosentyx in enthesitis-related arthritis and juvenile psoriatic arthritis will benefit you (or your child) by reducing the symptoms and improving your (or your child’s) physical function.

Do not use Cosentyx:
- if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, ask your doctor for advice before using Cosentyx.
- if you have an active infection which your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Cosentyx:
- if you currently have an infection.
- if you have long-term or repeated infections.
- if you have ever had an allergic reaction to latex.
- if you have an inflammatory disease affecting your gut called Crohn’s disease.
- if you have an inflammation of your large intestine called ulcerative colitis.
- if you have recently had a vaccination or if you are due to have a vaccination during treatment with Cosentyx.
- if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.

Tuberculosis
Talk to your doctor if you have or previously had tuberculosis. Also tell your doctor if you have recently been in close contact with someone who has tuberculosis. Your doctor will evaluate you and may do a test for tuberculosis before you use Cosentyx. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness or mild fever) appear during treatment with Cosentyx, tell your doctor immediately.

Hepatitis B
Talk to your doctor if you have or previously had a hepatitis B infection. This medicine may cause a reactivation of the infection. Before and during secukinumab treatment, your doctor may check you for signs of infection. Tell your doctor if you notice any of the following symptoms: worsening tiredness, yellowing of the skin or white part of the eyes, dark urine, loss of appetite, nausea and/or pain in the upper right side of the stomach area.

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems.

Look out for infections and allergic reactions
Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are taking Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and adolescents
Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because it has not been studied in this age group.

Cosentyx is not recommended for children younger than 6 years of age with juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis).

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications because it has not been studied in this age group.

Other medicines and Cosentyx
Tell your doctor or pharmacist:
- if you are taking, have recently taken or might take any other medicines.
- if you have recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breast-feeding and fertility
- It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose.
Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
- Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you will breast-feed or use Cosentyx. You should not do both. After using Cosentyx you should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines
Cosentyx is unlikely to influence your ability to drive and use machines.

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

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your doctor should decide if you should inject Cosentyx yourself.

It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. A caregiver may also give you your Cosentyx injection after proper training.

For detailed instructions on how to inject Cosentyx, see “Instructions for use of the Cosentyx 150 mg SensoReady pen” at the end of this leaflet.

Instructions for use can also be found via the following QR code and web site:
‘QR code to be included’ www.cosentyx.eu

How much Cosentyx is given and for how long
Your doctor will decide how much Cosentyx you need and for how long.

Plaque psoriasis
Adult
- The recommended dose is 300 mg by subcutaneous injection.
- Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Based on your response, further adjustments to your dose may be recommended by your doctor. At each timepoint you will receive a 300 mg dose given as two injections of 150 mg.

Children aged 6 years and older
- The recommended dose is based on body weight as follows:
o
Weight below 25 kg: 75 mg by subcutaneous injection.
o
Weight 25 kg or above and below 50 kg: 75 mg by subcutaneous injection.
o
Weight 50 kg or above: 150 mg by subcutaneous injection.
Your doctor may increase the dose to 300 mg.
- Each 150 mg dose is given as one injection of 150 mg. Other dosage forms/strengths may be available for administration of the 75 mg and 300 mg doses.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Hidradenitis suppurativa
- The recommended dose is 300 mg by subcutaneous injection.
- Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Based on your response, further adjustments to your dose may be recommended by your doctor.

Psoriatic arthritis
If you have both psoriatic arthritis and also moderate to severe plaque psoriasis, your doctor may adjust the dose recommendation as needed.

For patients who did not respond well to medicines called tumour necrosis factor (TNF) blockers:
- The recommended dose is 300 mg by subcutaneous injection.
- Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of 150 mg.

For other psoriatic arthritis patients:
- The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Based on your response, your doctor may increase your dose to 300 mg.

Ankylosing spondylitis (Radiographic axial spondyloarthritis)
- The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as two injections of 150 mg.

Non-radiographic axial spondyloarthritis
- The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis)
- The recommended dose is based on body weight as follows:
o
Weight below 50 kg: 75 mg by subcutaneous injection.
o
Weight 50 kg or above: 150 mg by subcutaneous injection.
- Each 150 mg dose is given as one injection of 150 mg. Other dosage forms/strengths may be available for administration of the 75 mg dose.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you use more Cosentyx than you should
If you have received more Cosentyx than you should or the dose has been administered sooner than according to your doctor’s prescription, inform your doctor.

If you forget to use Cosentyx
If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then talk to your doctor to discuss when you should inject the next dose.

If you stop using Cosentyx
It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or axial spondyloarthritis symptoms may come back.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the following side effects:

Possible serious infection - the signs may include:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters
- burning sensation when passing urine.

Serious allergic reaction - the signs may include:
- difficulty breathing or swallowing
- low blood pressure, which can cause dizziness or light-headedness
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps.
Your doctor will decide if and when you may restart the treatment.

Other side effects
Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people):
- upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis, rhinitis)

Common (may affect up to 1 in 10 people):
- cold sores (oral herpes)
- diarrhoea
- runny nose (rhinorrhoea)
- headache
- nausea
- fatigue
- itchy, red and dry skin (eczema)

Uncommon (may affect up to 1 in 100 people):
- oral thrush (oral candidiasis)
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
- infection of the external ear (otitis externa)
- discharge from the eye with itching, redness and swelling (conjunctivitis)
- itchy rash (urticaria)
- lower respiratory tract infections
- abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
- small, itchy blisters on the palms of hands, soles of feet and edges of the fingers and toes (dyshidrotic eczema)
- athlete’s foot (tinea pedis)

Rare (may affect up to 1 in 1 000 people):
- severe allergic reaction with shock (anaphylactic reaction)
- redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
- inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps (vasculitis)
- swelling of the neck, face, mouth or throat which may lead to difficulty swallowing or breathing (angioedema)

Not known (frequency cannot be estimated from the available data):
- fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
- painful swelling and skin ulceration (pyoderma gangrenosum)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 which is stated on the outer box or the label on the pen after “EXP”.
- if the liquid contains easily visible particles, is cloudy or is distinctly brown.

Store the pen sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. Do not freeze. Do not shake.
If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room temperature, not above 30°C.

This medicine is for single use only.

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

What Cosentyx contains
- The active substance is secukinumab. Each pre-filled pen contains 150 mg secukinumab.
- The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80 and water for injections.

What Cosentyx looks like and contents of the pack
Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow.
Cosentyx 150 mg solution for injection in pre-filled pen is available in unit packs containing 1 or 2 pre-filled pen(s) and in multipacks containing 6 (3 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1
Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

This leaflet was last revised in

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

Instructions for use of the Cosentyx 150 mg SensoReady pen

Cosentyx 150 mg SensoReady pen

Solution for injection in a pre-filled pen

Secukinumab

Patient Instructions for Use

Read ALL the way through these instructions before injecting.

These instructions are to help you to inject correctly using the Cosentyx
SensoReady pen.

It is important not to try to inject yourself or the person in your care until you have been trained by your doctor, nurse or pharmacist.

Your Cosentyx 150 mg SensoReady pen:

Cosentyx 150 mg SensoReady pen shown with the cap removed. Do not remove the cap until you are ready to inject.

Store your boxed pen in a refrigerator between 2°C and 8°C and out of the reach of children.

• Do not freeze the pen.
• Do not shake the pen.
• Do not use the pen if it has been dropped with the cap removed.

For a more comfortable injection, take the pen out of the refrigerator 15-30 minutes before injecting to allow it to reach room temperature.

What you need for your injection:

Included in the carton:

A new and unused Cosentyx
150 mg SensoReady pen (1 pen is needed for a 150 mg dose and
2 pens are needed for a 300 mg dose).
Not included in the carton:

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container.

Needle
Needle guard
Cap
Inspection window
Internal needle cover

Before your injection:

1. Important safety checks before you inject:
The liquid should be clear. Its colour may vary from colourless to slightly yellow.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. You may see a small air bubble, which is normal.
Do not use the pen if the expiry date has passed.
Do not use if the safety seal has been broken.

Contact your pharmacist if the pen fails any of these checks.

2a. Choose your injection site:
- The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
- Choose a different site each time you give yourself an injection.
- Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

2b. Caregivers and healthcare professionals only:
- If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.
3. Cleaning your injection site:
- Wash your hands with soap and hot water.
- Using a circular motion, clean the injection site with the alcohol swab. Leave it to dry before injecting.
- Do not touch the cleaned area again before injecting.

Your injection:

4. Removing the cap:
- Only remove the cap when you are ready to use the pen.
- Twist off the cap in the direction of the arrows.
- Once removed, throw away the cap. Do not try to re-attach the cap.
- Use the pen within 5 minutes of removing the cap.
5. Holding your pen:
- Hold the pen at 90 degrees to the cleaned injection site.

Correct
Incorrect

YOU MUST READ THIS BEFORE INJECTING.

During the injection you will hear 2 loud clicks.

The 1st click indicates that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.

You must keep holding the pen firmly against your skin until you see a green indicator fill the window and stop moving.

6. Starting your injection:
- Press the pen firmly against the skin to start the injection.
- The 1st click indicates the injection has started.
- Keep holding the pen firmly against your skin.
- The green indicator shows the progress of the injection.

7. Completing your injection:
- Listen for the 2nd click. This indicates the injection is almost complete.
- Check the green indicator fills the window and has stopped moving.
- The pen can now be removed.

After your injection:

8. Check the green indicator fills the window:
- This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.
- There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
9. Disposing of your Cosentyx SensoReady pen:
- Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
- Never try to reuse your pen.

it may not be safe for you to use.

needle cap.

may be activated too early.
7.
Do not remove the needle cap until just before you give the injection.
8.
The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps container.

Needle cap
Syringe guard
Viewing window label
& expiry date
Finger grips
Syringe guard wings
Plunger
Plunger head

Storage of the Cosentyx 300 mg pre-filled syringe
1.
Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator between 2°C and 8°C. DO NOT FREEZE.
2.
Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (30-45 minutes).
3.
Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”. If it has expired, return the entire pack to the pharmacy.

The injection site

The injection site is the place on the body where you are going to use the syringe.
- The recommended site is the front of your thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
- Choose a different site each time you give yourself an injection.
- Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

If a caregiver is giving you the injection, the outer upper arms may also be used.

Preparing the Cosentyx 300 mg pre-filled syringe ready for use
1.
Take the box containing the syringe out of the refrigerator and leave it unopened for about 30-45 minutes so that it reaches room temperature.
2.
When you are ready to use the syringe, wash your hands thoroughly with soap and water.
3.
Clean the injection site with an alcohol swab.
4.
Remove the syringe from the outer box and take it out of the blister by holding the syringe guard body.
5.
Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken.
In all these cases, return the entire product pack to the pharmacy.

How to use the Cosentyx 300 mg pre-filled syringe

Carefully remove the needle cap from the syringe by holding the syringe guard body.
Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.

Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in to ensure that the medicine can be fully administered.
Hold the syringe as shown. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.
Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Disposal instructions

Dispose of the used syringe in a sharps container
(closable, puncture resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis.

Cosentyx is used for the treatment of the following inflammatory diseases:
- Plaque psoriasis
- Hidradenitis suppurativa
- Psoriatic arthritis
- Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis

Plaque psoriasis
Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is used in adults, adolescents and children (6 years of age and older) with moderate to severe plaque psoriasis.

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.

Hidradenitis suppurativa
Cosentyx is used to treat a condition called hidradenitis suppurativa, also sometimes called acne inversa or Verneuil’s disease. This condition is a chronic and painful inflammatory skin disease.
Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It 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.

Cosentyx can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. If you have hidradenitis suppurativa you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx.

Cosentyx is used in adults with hidradenitis suppurativa and can be used alone or with antibiotics.

Psoriatic arthritis
Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and slow down the damage to the cartilage and bone of the joints involved in the disease.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate.

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to do normal daily activities.

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which cause inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation and improve your physical function.

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial spondyloarthritis.

Using Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit you by reducing the signs and symptoms of your disease and improving your physical function.

Do not use Cosentyx:
- if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, ask your doctor for advice before using Cosentyx.
- if you have an active infection which your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Cosentyx:
- if you currently have an infection.
- if you have long-term or repeated infections.
- if you have an inflammatory disease affecting your gut called Crohn’s disease.
- if you have an inflammation of your large intestine called ulcerative colitis.
- if you have recently had a vaccination or if you are due to have a vaccination during treatment with Cosentyx.
- if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.

Tuberculosis
Talk to your doctor if you have or previously had tuberculosis. Also tell your doctor if you have recently been in close contact with someone who has tuberculosis. Your doctor will evaluate you and may do a test for tuberculosis before you use Cosentyx. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness or mild fever) appear during treatment with Cosentyx, tell your doctor immediately.

Hepatitis B
Talk to your doctor if you have or previously had a hepatitis B infection. This medicine may cause a reactivation of the infection. Before and during secukinumab treatment, your doctor may check you for signs of infection. Tell your doctor if you notice any of the following symptoms: worsening tiredness, yellowing of the skin or white part of the eyes, dark urine, loss of appetite, nausea, and/or pain in the upper right side of the stomach area.

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems.

Look out for infections and allergic reactions
Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are taking Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and adolescents
Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because it has not been studied in this age group.

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications because it has not been studied in this age group.

Other medicines and Cosentyx
Tell your doctor or pharmacist:
- if you are taking, have recently taken or might take any other medicines.
- if you have recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breast-feeding and fertility
- It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose.
Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
- Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you will breast-feed or use Cosentyx. You should not do both. After using Cosentyx you should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines
Cosentyx is unlikely to influence your ability to drive and use machines.

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

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your doctor should decide if you should inject Cosentyx yourself.

It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. A caregiver may also give you your Cosentyx injection after proper training.

For detailed instructions on how to inject Cosentyx, see “Instructions for use of the Cosentyx 300 mg UnoReady pen” at the end of this leaflet.

Instructions for use can also be found via the following QR code and web site:
‘QR code to be included’ www.cosentyx.eu

How much Cosentyx is given and for how long
Your doctor will decide how much Cosentyx you need and for how long.

Plaque psoriasis
Adult
- The recommended dose is 300 mg by subcutaneous injection.
- Each 300 mg dose is given as one injection of 300 mg.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Based on your response, further adjustments to your dose may be recommended by your doctor. At each timepoint you will receive a 300 mg dose given as one injection of 300 mg.

Children aged 6 years and older
- The recommended dose is based on body weight as follows:
o
Weight below 25 kg: 75 mg by subcutaneous injection.
o
Weight 25 kg or above and below 50 kg: 75 mg by subcutaneous injection.
o
Weight 50 kg or above: 150 mg by subcutaneous injection.
Your doctor may increase the dose to 300 mg.
- Each 300 mg dose is given as one injection of 300 mg or as two injections of 150 mg. Other dosage forms/strengths may be available for administration of the 75 mg and 150 mg doses.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Hidradenitis suppurativa
- The recommended dose is 300 mg by subcutaneous injection.
- Each 300 mg dose is given as one injection of 300 mg.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Based on your response, further adjustments to your dose may be recommended by your doctor.

Psoriatic arthritis
If you have both psoriatic arthritis and also moderate to severe plaque psoriasis, your doctor may adjust the dose recommendation as needed.

For patients who did not respond well to medicines called tumour necrosis factor (TNF) blockers:
- The recommended dose is 300 mg by subcutaneous injection.
- Each 300 mg dose is given as one injection of 300 mg.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. At each timepoint you will receive a 300 mg dose given as one injection of 300 mg.

For other psoriatic arthritis patients:
- The recommended dose is 150 mg by subcutaneous injection. Other dosage forms/strengths are available for the 150 mg dose.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Based on your response, your doctor may increase your dose to 300 mg.

Ankylosing spondylitis (Radiographic axial spondyloarthritis)
- The recommended dose is 150 mg by subcutaneous injection. Other dosage forms/strengths are available for the 150 mg dose.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as one injection of 300 mg.

Non-radiographic axial spondyloarthritis
- The recommended dose is 150 mg by subcutaneous injection. Other dosage forms/strengths are available for the 150 mg dose.

After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you use more Cosentyx than you should
If you have received more Cosentyx than you should or the dose has been administered sooner than according to your doctor’s prescription, inform your doctor.

If you forget to use Cosentyx
If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then talk to your doctor to discuss when you should inject the next dose.

If you stop using Cosentyx
It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or axial spondyloarthritis symptoms may come back.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the following side effects:

Possible serious infection - the signs may include:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters
- burning sensation when passing urine.

Serious allergic reaction - the signs may include:
- difficulty breathing or swallowing
- low blood pressure, which can cause dizziness or light-headedness
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps.
Your doctor will decide if and when you may restart the treatment.

Other side effects
Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people):
- upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis, rhinitis)

Common (may affect up to 1 in 10 people):
- cold sores (oral herpes)
- diarrhoea
- runny nose (rhinorrhoea)
- headache
- nausea
- fatigue
- itchy, red and dry skin (eczema)

Uncommon (may affect up to 1 in 100 people):
- oral thrush (oral candidiasis)
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
- infection of the external ear (otitis externa)
- discharge from the eye with itching, redness and swelling (conjunctivitis)
- itchy rash (urticaria)
- lower respiratory tract infections
- abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
- small, itchy blisters on the palms of hands, soles of feet and edges of the fingers and toes (dyshidrotic eczema)
- athlete’s foot (tinea pedis)

Rare (may affect up to 1 in 1 000 people):
- severe allergic reaction with shock (anaphylactic reaction)
- redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
- inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps (vasculitis)
- swelling of the neck, face, mouth or throat which may lead to difficulty swallowing or breathing (angioedema)

Not known (frequency cannot be estimated from the available data):
- fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
- painful swelling and skin ulceration (pyoderma gangrenosum)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 which is stated on the outer box or the label on the pen after “EXP”.
- if the liquid contains easily visible particles, is cloudy or is distinctly brown.

Store the pen sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. Do not freeze. Do not shake.
If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room temperature, not above 30°C.

This medicine is for single use only.

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

What Cosentyx contains
- The active substance is secukinumab. Each pre-filled pen contains 300 mg secukinumab.
- The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80 and water for injections.

What Cosentyx looks like and contents of the pack
Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow.
Cosentyx 300 mg solution for injection in pre-filled pen is available in a pack containing 1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1
Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

This leaflet was last revised in

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

Instructions for use of Cosentyx 300 mg UnoReady pen

secukinumab

Read ALL the way through these instructions before injecting.

These instructions are to help you to inject correctly using the Cosentyx
UnoReady pen.

It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.

Your Cosentyx 300 mg UnoReady pen:

Cosentyx 300 mg UnoReady pen is shown above with the cap removed. Do not remove the cap until you are ready to inject.
Do not use the Cosentyx UnoReady pen if the seal on the outer carton is broken.

Keep the Cosentyx UnoReady pen in the sealed outer carton until you are ready to use it to protect it from light.

Store your Cosentyx UnoReady pen in a refrigerator between 2°C and 8°C and out of the reach of children.

• Do not freeze the pen.
• Do not shake the pen.
• Do not use the pen if it has been dropped with the cap removed.

The needle is covered by the needle guard and the needle will not be seen. Do not touch or push the needle guard because you could get a needle stick injury.

What you need for your injection:

Included in the carton:

A new and unused Cosentyx
300 mg UnoReady pen.

Not included in the carton:

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container.

Cap
Needle guard
Internal needle cover
Viewing window

Before your injection:

Take the Cosentyx 300 mg UnoReady pen out of the refrigerator 30 to 45 minutes before injecting to allow it to reach room temperature.

1. Important safety checks before you inject:

For the “Viewing window”:
The liquid should be clear. Its colour may vary from colourless to slightly yellow.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. You may see a small air bubble, which is normal.

For the “Expiry date”:
Look at the expiry date (EXP) on your Cosentyx UnoReady pen. Do not use the pen if the expiry date has passed.

Check that your pen contains the correct medicine and dose.

Contact your pharmacist if the pen fails any of these checks.

2a. Choose your injection site:
- The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
- Choose a different site each time you give yourself an injection.
- Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

2b. Caregivers and healthcare professionals only:
- If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.
3. Cleaning your injection site:
- Wash your hands with soap and hot water.
- Using a circular motion, clean the injection site with the alcohol swab. Leave it to dry before injecting.
- Do not touch the cleaned area again before injecting.

Viewing window
Expiry date (EXP)

Your injection:

4. Removing the cap:
- Only remove the cap when you are ready to use the pen.
- Pull the cap straight off in the direction of the arrow that is shown in the figure on the left.
- Once removed, throw away the cap. Do not try to re-attach the cap.
- Use the pen within 5 minutes of removing the cap.
5. Holding your pen:
- Hold the pen at 90 degrees to the cleaned injection site.

Correct
Incorrect

YOU MUST READ THIS BEFORE INJECTING.

During the injection you will hear 2 clicks.

The 1st click indicates that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.

You must keep holding the pen firmly against your skin until you see a green indicator with a grey tip fill the window and stop moving.

6. Starting your injection:
- Press the pen firmly against the skin to start the injection.
- The 1st click indicates the injection has started.
- Keep holding the pen firmly against your skin.
The green indicator with the grey tip shows the progress of the injection.
1st CLICK

7. Completing your injection:
- Listen for the 2nd click. This indicates the injection is almost complete.
- Check the green indicator with the grey tip fills the window and has stopped moving.
- The pen can now be removed.

After your injection:

8. Check the green indicator fills the window:
- This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.
- There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
9. Disposing of your Cosentyx 300 mg UnoReady pen:
- Dispose of the used pen in a sharps disposal container
(i.e. a puncture-resistant closable container, or similar).
- Never try to reuse your pen.

2nd CLICK

the solution in the vial when drawing the solution into the syringe. DO NOT invert the vial.

for subcutaneous injection from the vial into a 1 ml graduated disposable syringe using a suitable needle (e.g. 21G x 2″). This needle will only be used for withdrawing Cosentyx into the disposable syringe. Prepare the required number of syringes (2 syringes for the 300 mg dose).
For a child receiving the 75 mg dose, carefully withdraw slightly more than 0.5 ml of the solution for subcutaneous injection and discard the rest immediately.

Expel the air bubbles and advance the plunger to the 0.5 ml mark for the 75 mg dose.

7.
Inject the Cosentyx solution subcutaneously into the front of thighs, lower abdomen (but not the area 5 centimetres around the navel) or outer upper arms. Choose a different site each time an injection is administered. Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

8.
Any remaining solution in the vial must not be used and should be discarded in accordance with local requirements. Vials are for single use only. Dispose of the used syringe in a sharps container (closable, puncture-resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.