guselkumab: package leaflet

Allow Tremfya to come to room temperature and inspect carton
Remove the carton from the refrigerator and let the carton sit on a flat surface at room temperature for approximately 30 minutes before use.
Do not warm the pre-filled pen any other way.
Check the expiry date (‘EXP’) on the carton.
Do not use the pre-filled pen if the expiry date has passed or if the seal on the carton is broken. Call your doctor or pharmacist for a new pre-filled pen.
WAIT
MINUTES

Choose injection site
Select a site from the following areas for the injection:

Front of thighs

Lower stomach area (lower abdomen), avoiding the 5-centimetre area around the navel (belly-button)  Back of upper arms Do not inject into skin that is tender, bruised, red, scaly, hard, thick, has scars, or is affected by psoriasis.
Wash hands and
Clean injection site
Wash your hands well with soap and warm water.
Wipe the chosen injection site with an alcohol swab and allow it to dry by air.
Do not touch, fan, or blow on the injection site after you have cleaned it.

Inspect liquid in viewing window
Take the pre-filled pen out of the carton.
Check the liquid in the viewing window. It should be clear and colourless to slightly yellow and may contain tiny white or clear particles.
.
You may also see air bubbles.
This is normal.
Do not inject if the liquid is:
 cloudy or
 discoloured or
 has large particles
Call your doctor or pharmacist for a new pre-filled pen.

Keep the pre-filled pen pointing up during this step
Tap pre-filled pen to move air bubbles to the top even if you do not see any air bubbles Hold the pre-filled pen with the teal-coloured cap pointing up.
Tap gently near the viewing window. This will cause any air bubbles to rise to the top.
Do not set the pre-filled pen down until air bubbles are removed.
Remove cap
Keep holding the pre-filled pen with the teal cap pointing up, then pull the cap to remove.
Keep hands away from the orange needle guard after the cap is removed.
Pushing the needle guard too soon may lock the pre-filled pen and you will not be able to give the dose.
Do not put the cap back on as this may damage the needle.
Do not use the pre-filled pen if it is dropped after removing the cap. Call your doctor or pharmacist for a new pre-filled pen.

Press the plunger until it stops to push out air bubbles
Keep holding the pre-filled pen with the orange needle guard pointing up.
Confirm air bubbles are removed by checking that the orange priming band is no longer visible in the dose selection notch.
Liquid may squirt out. This is normal.
AFTER
BEFORE
Dose selection notch
Orange priming band
Plunger

Turn the plunger to set the dose
Turn the plunger until the dose line and dose number that corresponds to the prescribed dose (see table below) is in the dose selection notch as shown in the image above.
Prescribed dose
Turn plunger to:
20 mg =
20 mg
25 mg =
30 mg =
35 mg =
40 mg =
45 mg =
Dose selection notch
Dose line
Dose number
Plunger

Read all sub-steps from A to D before injecting
Position pre-filled pen straight onto the injection site
Position the pre-filled pen straight onto the injection site with the orange needle guard against the skin and the viewing window facing you.
Continue to hold the pre-filled pen against the skin.
Push pre-filled pen down to insert the needle into the skin and hold in place
Do not press the plunger yet.
Do not lift the pre-filled pen from the skin.
Push the pre-filled pen into the skin until the orange needle guard stops to insert the needle into the skin. Some orange will still be showing.
90°
B
A

Slowly press the plunger all the way down until it stops to inject Tremfya
Do not lift the pre-filled pen from the skin during the injection.
Otherwise, the orange needle guard will lock, and you will not be able to give the full dose.
You will feel some resistance as you press the plunger. This is normal.
If a small dose is set, the plunger will only move a short distance.
Hold and confirm injection is complete
Hold the pre-filled pen in place and keep pushing against the skin for 5 seconds.
Confirm injection is complete by checking that:
 you cannot press the plunger down any more
 the selected blue dose line is no longer visible
 only the selected dose number is visible in the dose selection notch
After confirming, lift the pre-filled pen from the skin.
The orange needle guard will extend and lock.
It is normal to see some liquid left in the viewing window.
D
HOLD
SECONDS
Dose number
Dose selection notch
BEFORE
AFTER
C

Check injection site
There may be a small amount of blood or liquid at the injection site. Gently hold pressure over the injection site with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site.
If needed, cover injection site with a bandage.
Dispose of the pre-filled pen
Put the used pre-filled pen in a sharps disposal container right away after use.
Do not throw away (dispose of) the pre-filled pen in your household waste.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Do not recycle the used sharps disposal container.

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
Plaque psoriasis
Adults
Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.
Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Children
Tremfya is used to treat children 6 years of age and older with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin.
Tremfya can improve the condition of the skin and reduce signs and symptoms, such as scaling and redness.
Psoriatic arthritis
Tremfya is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by plaque psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Tremfya to reduce the signs and symptoms of the disease. Tremfya can be used alone or with another medicine named methotrexate.

Using Tremfya 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.
Ulcerative colitis
Tremfya is used to treat adults with moderate to severe ulcerative colitis, an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in ulcerative colitis can benefit you by reducing the signs and symptoms of the disease including bloody stools, the need to rush to and the number of times you go to the toilet, abdominal pain and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.
Crohn’s disease
Tremfya is used to treat adults with moderate to severe Crohn’s disease, an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in Crohn’s disease can benefit you by reducing the signs and symptoms of the disease such as diarrhoea, abdominal pain, and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.

Do not use Tremfya
 if you are allergic to guselkumab 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 Tremfya.
 if you have an active infection, including active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection;
 if you have an infection that does not go away or that keeps coming back;
 if you have tuberculosis or have been in close contact with someone with tuberculosis;
 if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions’);
 if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya. Children need to be brought up to date with age-appropriate vaccines prior to beginning Tremfya.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya.
As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Tremfya and when using it. Increases in liver enzymes may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see “How to use Tremfya” in section 3).
Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Tremfya.
Signs or symptoms of infections may include fever or flu like symptoms; muscle aches; cough;
shortness of breath; burning when you urinate or urinating more often than usual; blood in your

phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis.
Serious allergic reactions have occurred with Tremfya. Symptoms may include, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, lightheadedness or dizziness, or hives (see “Serious side effects” in section 4).
Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Children and adolescents
Do not give this medicine to children under 6 years of age with plaque psoriasis or in children under 18 years of age with psoriatic arthritis, ulcerative colitis, and Crohn’s disease because it has not been studied in these age groups.
Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Pregnancy and breast-feeding

Tremfya should not be used in pregnancy as 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 Tremfya and for at least 12 weeks after the last Tremfya 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 Tremfya.
Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.
Tremfya contains polysorbate 80
This medicine contains 0.5 mg of polysorbate 80 in each pre-filled syringe which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Tremfya is given and for how long
Your doctor will decide for how long you need to use Tremfya.
Plaque psoriasis
Adults:

The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.
Children:

For children weighing 40 kg or more, the dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.


For children weighing less than 40 kg a 45 mg/0.45 mL pre-filled pen is available.

After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.
Psoriatic arthritis

The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks. For some patients, after the first dose, Tremfya may be given every 4 weeks. Your doctor will decide how often you may receive Tremfya.
Ulcerative colitis
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
Crohn’s disease
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
You may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
Children below the age of 18 years should not self-inject Tremfya. Your doctor may decide that your caregiver may be able to give Tremfya after receiving appropriate training on how to inject Tremfya.
For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before use, which is included in the carton.

If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.
If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.
If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your 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 Tremfya and tell your doctor or seek medical help immediately if you get any of the following side effects:
Possible serious allergic reaction (may affect up to 1 in1 000 people) - the signs or symptoms may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
- lightheadedness, low blood pressure, or dizziness
Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Very common (may affect more than 1 in 10 people)
- respiratory tract infections
Common (may affect up to 1 in 10 people)
- headache
- joint pain (arthralgia)
- diarrhoea
- increased level of liver enzymes in the blood
- skin rash
- redness, irritation or pain at the injection site
Uncommon (may affect up to 1 in 100 people)
- decreased number of a type of white blood cell called neutrophils
- herpes simplex infections
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- stomach flu (gastroenteritis)
- hives
Rare (may affect up to 1 in 1 000 people)
- allergic reaction
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 syringe label and on the outer carton after “EXP”. The expiry date refers to the last day of that month.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not shake.
Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles. Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes.
This medicine is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tremfya contains
- The active substance is guselkumab. Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections (see section 2 “Tremfya contains polysorbate 80”).
What Tremfya looks like and contents of the pack
Tremfya is a clear, colourless to light yellow solution for injection (injection). It is available in packs containing one pre-filled syringe and in multipacks comprising 2 cartons, each containing 1 pre-filled syringe. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333CB Leiden
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11 janssen@jacbe.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0 800 086 9247 / +49 2137 955 6955 jancil@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com

Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
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
Tremfya
100 mg pre-filled syringe
Important
If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled syringe before attempting to inject. Do not try to inject yourself until you have been shown the right way to give the injections by your doctor.
For paediatric patients, Tremfya should be administered by a doctor or nurse or a caregiver who has been shown the right way to give the injections by your doctor.
Please read these Instructions for use before using the Tremfya pre-filled syringe and each time you get a refill. There may be new information. This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment. Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
The Tremfya pre-filled syringe is intended for injection under the skin, not into the muscle or vein.
After injection, the needle will retract into the body of the device and lock into place.
Storage information
Store in refrigerator at 2° to 8°C. Do not freeze.
Keep your pre-filled syringe in the original carton to protect from light and physical damage.
Keep Tremfya and all medicines out of reach of children.
Do not shake the pre-filled syringe at any time.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.
SINGLE-USE DEVICE

Pre-filled syringe at-a-glance
Before injection
Plunger
Do not hold or pull plunger at any time.
Safety guard
Finger flange
Body
Hold syringe body below finger flange.
Viewing window
Needle cover
Do not remove until you are ready to inject
Tremfya (See step 2).

After injection
You will need these supplies:

1 Alcohol swab

1 Cotton ball or gauze pad

1 Adhesive bandage

1 Sharps container (See step 3)
Plunger stops
Safety guard activates
Needle retracts into the body

1. Prepare for your injection
Inspect carton
Remove carton with the pre-filled syringe from the refrigerator.
Keep the pre-filled syringe in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
Do not warm any other way.
Check the expiry date (‘EXP’) on the back panel of the carton.
Do not use if the expiry date has passed.
Do not inject if the perforations on the carton are broken.
Call your doctor or pharmacist for a refill.
Choose injection site
Select from the following areas for your injection:

Front of thighs (recommended)

Lower abdomen
Do not use the 5-centimetre area around your belly-button.

Back of upper arms (if a caregiver is giving you the injection)
Do not inject into skin that is tender, bruised, red, scaly or hard.
Do not inject into areas with scars or stretch marks.
MIN

Clean injection site
Wash your hands well with soap and warm water.
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan or blow on the injection site after you have cleaned it.
Inspect liquid
Take the pre-filled syringe out of the carton.
Check the liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles.
This is normal.
Do not inject if the liquid is cloudy or discoloured, or has large particles. If you are uncertain, call your doctor or pharmacist for a refill.

2. Inject Tremfya using the pre-filled syringe
Remove needle cover
Hold syringe by the body and pull needle cover straight off.
It is normal to see a drop of liquid.
Inject within 5 minutes of removing the needle cover.
Do not put needle cover back on, as this may damage the needle.
Do not touch needle or let it touch any surface.
Do not use the Tremfya pre-filled syringe if it is dropped. Call your doctor or pharmacist for a refill.
Position fingers and insert needle
Place your thumb, index and middle fingers directly under the finger flange, as shown.
Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
Use your other hand to pinch skin at the injection site. Position syringe at about a 45 degree angle to the skin.
It is important to pinch enough skin to inject under the skin and not into the muscle.
Insert needle with a quick, dart-like motion.

Release pinch and reposition hand
Use your free hand to grasp the body of the syringe.
Press plunger
Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops.
Release pressure from plunger
The safety guard will cover the needle and lock into place, removing the needle from your skin.

3. After your injection
Throw the used pre-filled syringe away
Put your used syringe in a sharps disposal container right away after use.
Do not throw away (dispose of) your pre-filled syringe in your household waste.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Check injection site
There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site.
If needed, cover injection site with a bandage.
Your injection is now complete!

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
Plaque psoriasis
Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.
Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Psoriatic arthritis
Tremfya is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by plaque psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Tremfya to reduce the signs and symptoms of the disease. Tremfya can be used alone or with another medicine named methotrexate.
Using Tremfya 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.
Ulcerative colitis
Tremfya is used to treat adults with moderate to severe ulcerative colitis, an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.

Using Tremfya in ulcerative colitis can benefit you by reducing the signs and symptoms of the disease including bloody stools, the need to rush to and the number of times you go to the toilet, abdominal pain and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.
Crohn’s disease
Tremfya is used to treat adults with moderate to severe Crohn’s disease, an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in Crohn’s disease can benefit you by reducing the signs and symptoms of the disease such as diarrhoea, abdominal pain, and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.

Do not use Tremfya
 if you are allergic to guselkumab 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 Tremfya.
 if you have an active infection, including active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection;
 if you have an infection that does not go away or that keeps coming back;
 if you have tuberculosis or have been in close contact with someone with tuberculosis;
 if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions’);
 if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya.
As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Tremfya and when using it. Increases in liver enzymes may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see “How to use Tremfya” in section 3).
Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Tremfya.
Signs or symptoms of infections may include fever or flu like symptoms; muscle aches; cough;
shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis.
Serious allergic reactions have occurred with Tremfya. Symptoms may include, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, lightheadedness or dizziness, or hives (see “Serious side effects” in section 4).
Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.

Children and adolescents
Do not give this medicine to children and adolescents less than 18 years of age because it has not been studied in this age group..
Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Pregnancy and breast-feeding

Tremfya should not be used in pregnancy as 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 Tremfya and for at least 12 weeks after the last Tremfya 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 Tremfya.
Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.
Tremfya contains polysorbate 80
This medicine contains 0.5 mg of polysorbate 80 in each pre-filled pen which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Tremfya is given and for how long
Your doctor will decide for how long you need to use Tremfya.
Plaque psoriasis

The dose is 100 mg (the content of 1 pre-filled pen) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.
Psoriatic arthritis

The dose is 100 mg (the content of 1 pre-filled pen) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks. For some patients, after the first dose, Tremfya may be given every 4 weeks. Your doctor will decide how often you may receive Tremfya.
Ulcerative colitis
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.


Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
Crohn’s disease
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
You may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before use, which is included in the carton.
If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.
If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.
If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your 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 Tremfya and tell your doctor or seek medical help immediately if you get any of the following side effects:
Possible serious allergic reaction (may affect up to 1 in 1 000 people) - the signs or symptoms may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
- lightheadedness, low blood pressure, or dizziness
Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Very common (may affect more than 1 in 10 people)
- respiratory tract infections
Common (may affect up to 1 in 10 people)
- headache
- joint pain (arthralgia)
- diarrhoea
- increased level of liver enzymes in the blood
- skin rash
- redness, irritation or pain at the injection site
Uncommon (may affect up to 1 in 100 people)
- decreased number of a type of white blood cell called neutrophils
- herpes simplex infections
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- stomach flu (gastroenteritis)
- hives
Rare (may affect up to 1 in 1 000 people)
- allergic reaction
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 pre-filled pen label and on the outer carton after “EXP”. The expiry date refers to the last day of that month.
Keep the pre-filled pen in the outer carton in order to protect from light.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not shake.

Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles. Before use, remove the carton from the refrigerator and keep the pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes.
This medicine is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tremfya contains
- The active substance is guselkumab. Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections (see section 2 “Tremfya contains polysorbate 80”).
What Tremfya looks like and contents of the pack
Tremfya is a clear, colourless to light yellow solution for injection (injection). It is available in packs containing one pre-filled pen and in multipacks comprising 2 cartons, each containing 1 pre-filled pen.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333CB Leiden
The Netherlands
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11 janssen@jacbe.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0 800 086 9247 / +49 2137 955 6955 jancil@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
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.

Instructions for use
Tremfya
100 mg OnePress pre-filled pen
Important
If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled pen.
Please read these Instructions for use before using the Tremfya pre-filled pen and each time you get a new pre-filled pen. There may be new information. This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
During injection, push handle all the way down until green body is not visible to inject the full dose.
DO NOT LIFT THE PRE-FILLED PEN during injection. If you do, the pre-filled pen will lock and you will not get the full dose.
Storage information
Store in refrigerator at 2° to 8°C.
Do not freeze.
Do not shake your pre-filled pen at any time.
Keep your pre-filled pen in the original carton to protect from light and physical damage.
Keep Tremfya and all medicines out of reach of children.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.
SINGLE-USE DEVICE

Pre-filled pen at-a-glance
Before use
After use
You will need these supplies:
• 1 Alcohol swab
• 1 Cotton ball or gauze pad
• 1 Adhesive bandage
• 1 Sharps container (See step 3)
Handle
Green Body
Window
Needle Guard
Bottom Cap
Remove cap when ready to inject
(see Step 2).
Handle is pressed all the way down.
The green body is not visible.
After lifting, the needle guard locks and the yellow band is visible.
Do not lift during the injection.

1. Prepare for your injection
Inspect carton and allow Tremfya to come to room temperature
Remove carton with the pre-filled pen from the refrigerator.
Keep pre-filled pen in the carton and let it sit on a flat surface at room temperature for approximately 30 minutes before use.
Do not warm any other way.
Check the expiry date (‘EXP’) on the carton.
Do not use if the expiry date has passed.
Do not inject if the seal on the carton is broken.
Call your doctor or pharmacist for a new pre-filled pen.
WAIT
MIN
EXP

Choose injection site
Select from the following areas for your injection:

Front of thighs (recommended)

Lower abdomen
Do not use the 5-centimetre area around your belly-button.

Back of upper arms (if a caregiver is giving you the injection)
Do not inject into skin that is tender, bruised, red, scaly, hard or has scars or stretch marks.
Wash hands
Wash your hands well with soap and warm water.
Clean injection site
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan or blow on the injection site after you have cleaned it.

Inspect liquid in window
Take the pre-filled pen out of the carton.
Check the liquid in the window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles.
This is normal.
Do not inject if the liquid is:
 cloudy, or
 discoloured, or
 has large particles.
If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.

2. Inject Tremfya using the pre-filled pen
Pull off bottom cap when you are ready to inject
Keep hands away from the needle guard after the cap is removed. It is normal to see a few drops of liquid.
Inject within 5 minutes of removing the cap.
Do not put the cap back on. This could damage the needle.
Do not use the pre-filled pen if it is dropped after removing the cap.
Call your doctor or pharmacist for a new pre-filled pen.
Place straight on skin
Push handle all the way down until green body is not visible
DO NOT LIFT THE PRE-FILLED PEN DURING THE INJECTION!
If you do, the needle guard will lock, showing a yellow band, and you will not get the full dose.

You may hear a click when the injection begins. Keep pushing.
If you feel resistance, keep pushing. This is normal.
The medication injects as you push. Do this at a speed that is comfortable for you.
Confirm injection is complete
Injection is complete when:

The green body is no longer visible

You cannot press the handle down anymore

You may hear a click
Lift straight up
The yellow band indicates that the needle guard is locked.
click

3. After your injection
Throw the used pre-filled pen away
Put your used pre-filled pen in a sharps disposal container right away after use.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Do not throw away (dispose of) your pre-filled pen in your household waste.
Do not recycle your used sharps disposal container.
Check injection site
There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site.
If needed, cover injection site with a bandage.
Your injection is now complete!

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
Plaque psoriasis
Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.
Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Psoriatic arthritis
Tremfya is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by plaque psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Tremfya to reduce the signs and symptoms of the disease. Tremfya can be used alone or with another medicine named methotrexate.
Using Tremfya 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.
Ulcerative colitis
Tremfya is used to treat adults with moderate to severe ulcerative colitis, an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.

Using Tremfya in ulcerative colitis can benefit you by reducing the signs and symptoms of the disease including bloody stools, the need to rush to and the number of times you go to the toilet, abdominal pain and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.
Crohn’s disease
Tremfya is used to treat adults with moderate to severe Crohn’s disease, an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in Crohn’s disease can benefit you by reducing the signs and symptoms of the disease such as diarrhoea, abdominal pain, and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.

Do not use Tremfya
 if you are allergic to guselkumab 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 Tremfya.
 if you have an active infection, including active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection;
 if you have an infection that does not go away or that keeps coming back;
 if you have tuberculosis or have been in close contact with someone with tuberculosis;
 if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions’);
 if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya.
As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Tremfya and when using it. Increases in liver enzymes may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see “How to use Tremfya” in section 3).
Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Tremfya.
Signs or symptoms of infections may include fever or flu like symptoms; muscle aches; cough;
shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis.
Serious allergic reactions have occurred with Tremfya. Symptoms may include, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, lightheadedness or dizziness, or hives (see “Serious side effects” in section 4).
Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.

Children and adolescents
Do not give this medicine to children and adolescents less than 18 years of age because it has not been studied in this age group..
Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Pregnancy and breast-feeding

Tremfya should not be used in pregnancy as 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 Tremfya and for at least 12 weeks after the last Tremfya 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 Tremfya.
Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.
Tremfya contains polysorbate 80
This medicine contains 0.5 mg of polysorbate 80 in each pre-filled pen which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Tremfya is given and for how long
Your doctor will decide for how long you need to use Tremfya.
Plaque psoriasis

The dose is 100 mg (the content of 1 pre-filled pen) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.
Psoriatic arthritis

The dose is 100 mg (the content of 1 pre-filled pen) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks. For some patients, after the first dose, Tremfya may be given every 4 weeks. Your doctor will decide how often you may receive Tremfya.
Ulcerative colitis
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.


Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
Crohn’s disease
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
You may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before use, which is included in the carton.
If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.
If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.
If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your 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 Tremfya and tell your doctor or seek medical help immediately if you get any of the following side effects:
Possible serious allergic reaction (may affect up to 1 in 1 000 people) - the signs or symptoms may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
- lightheadedness, low blood pressure, or dizziness
Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Very common (may affect more than 1 in 10 people)
- respiratory tract infections
Common (may affect up to 1 in 10 people)
- headache
- joint pain (arthralgia)
- diarrhoea
- increased level of liver enzymes in the blood
- skin rash
- redness, irritation or pain at the injection site
Uncommon (may affect up to 1 in 100 people)
- decreased number of a type of white blood cell called neutrophils
- herpes simplex infections
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- stomach flu (gastroenteritis)
- hives
Rare (may affect up to 1 in 1 000 people)
- allergic reaction
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 pre-filled pen label and on the outer carton after “EXP”. The expiry date refers to the last day of that month.
Keep the pre-filled pen in the outer carton in order to protect from light.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not shake.

Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles. Before use, remove the carton from the refrigerator and keep the pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes.
This medicine is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tremfya contains
- The active substance is guselkumab. Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections (see section 2 “Tremfya contains polysorbate 80”).
What Tremfya looks like and contents of the pack
Tremfya is a clear, colourless to light yellow solution for injection (injection). It is available in packs containing one pre-filled pen and in multipacks comprising 2 cartons, each containing 1 pre-filled pen.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333CB Leiden
The Netherlands
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11 janssen@jacbe.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0 800 086 9247 / +49 2137 955 6955 jancil@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
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.

Instructions for use
Tremfya
100 mg PushPen pre-filled pen
SINGLE-USE DEVICE

Important
Tremfya comes in a single-use pre-filled pen containing one 100 mg dose.
If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled pen.
Please read these Instructions for Use before using the Tremfya pre-filled pen and each time you get a new pre-filled pen. There may be new information. This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment. Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Each Tremfya pre-filled pen can only be used one time. Throw the used pre-filled pen away (see Step 4) after one dose, even if there is still medicine left in it. Do not reuse your pre-filled pen.
Storage information
Store in refrigerator at 2° to 8°C.
Do not freeze.
Do not shake your pre-filled pen.
Keep your pre-filled pen in the original carton to protect from light and physical damage.
Keep Tremfya and all medicines out of reach of children.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.

Pre-filled pen at-a-glance
You will need:
- 1 pre-filled pen
Not provided in the carton:
- Alcohol swabs
- Cotton balls or gauze pads
- Adhesive bandages
- Sharps container (See Step 4)
Before use
Yellow plunger rod fills the viewing window
After use
Viewing
Window
Green Needle
Guard
Thin Hidden
Needle
Cap
Do not remove until you are ready to inject
(See Step 3)

1. Get ready
Allow Tremfya to come to room temperature
Remove the carton from the refrigerator and let the carton sit on a flat surface at room temperature for approximately 30 minutes before use.
Do not warm the pre-filled pen any other way.
Check the expiry (‘EXP’) date on the carton.
Do not use the pre-filled pen if the expiry date has passed or if the seal on the carton is broken.
Call your doctor or pharmacist for a new pre-filled pen.
2. Prepare for your injection
Inspect liquid in window to see that it is clear to slightly yellow
Take the pre-filled pen out of the carton.
Check the liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see air bubbles.
This is normal.
Do not inject if the liquid is:
 cloudy or
 discoloured or
 has large particles
If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
WAIT
MIN

Choose injection site
Select from the following areas for your injection:

Front of thighs

Lower stomach area (lower abdomen)
Do not use the 5-centimetre area around your belly-button.

Back of upper arms (if a caregiver is giving you the injection)
Do not inject into skin that is tender, bruised, red, scaly, thick or hard. Avoid areas with scars or stretch marks.
Wash hands and clean injection site
Wash your hands well with soap and warm water.
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after you have cleaned it.

3. Inject Tremfya using the pre-filled pen
Remove cap when you are ready to inject
Do Not Touch Green Needle Guard!
This may start the injection and you will not receive the dose.
Pull the cap straight off. It is normal to see a few drops of liquid.
Inject Tremfya within 5 minutes of removing cap.
Do not put the cap back on as this may damage the needle.
Do not use the pre-filled pen if it is dropped after removing the cap.
Call your doctor or pharmacist for a new pre-filled pen.
Position pre-filled pen straight onto the injection site then push and hold pre-filled pen Do Not Lift The Pre-Filled Pen During Injection!
If you do, the green needle guard will lock and the full dose will not be delivered.
Position the pre-filled pen straight onto the injection site with the green needle guard against the skin and the viewing window facing you.
Press down on the pre-filled pen and keep holding it down against the skin.
1st
CLICK!

You will hear the first click.
Keep holding the pre-filled pen firmly against the skin for about 10 seconds to hear a second click You are almost done.
Keep holding firmly against the skin and confirm the injection is complete
The injection is complete when the yellow plunger rod stops moving and fills the viewing window.
SEC
2nd
CLICK!

Lift straight up
4. After your injection
Check injection site
There may be a small amount of blood or liquid at the injection site. Gently hold pressure over the injection site with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a bandage.
Your injection is now complete!
Throw away the used pre-filled pen and cap
Put your used pre-filled pen and cap in a sharps disposal container right away after use.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Do not throw away (dispose of) your pre-filled pen in your household waste.
Do not recycle your used sharps disposal container.

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with ulcerative colitis and Crohn’s disease.
Ulcerative colitis
Tremfya is used to treat adults with moderate to severe ulcerative colitis, an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in ulcerative colitis can benefit you by reducing the signs and symptoms of the disease including bloody stools, the need to rush to and the number of times you go to the toilet, abdominal pain and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.
Crohn’s disease
Tremfya is used to treat adults with moderate to severe Crohn’s disease, an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in Crohn’s disease can benefit you by reducing the signs and symptoms of the disease such as diarrhoea, abdominal pain, and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.

Do not use Tremfya
 if you are allergic to guselkumab 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 Tremfya.
 if you have an active infection, including active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection;
 if you have an infection that does not go away or that keeps coming back;
 if you have tuberculosis or have been in close contact with someone with tuberculosis;
 if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions’);
 if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya.
As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Tremfya and when using it. Increases in liver enzymes may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see “How to use Tremfya” in section 3).
Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Tremfya.
Signs or symptoms of infections may include fever or flu like symptoms; muscle aches; cough;
shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body.
Serious allergic reactions have occurred with Tremfya. Symptoms may include, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, lightheadedness or dizziness, or hives (see “Serious side effects” in section 4).
Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Children and adolescents
Do not give this medicine to children and adolescents less than 18 years of age because it has not been studied in this age group.
Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Pregnancy and breast-feeding

Tremfya should not be used in pregnancy as 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 Tremfya and for at least 12 weeks

after the last Tremfya 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 Tremfya.
Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.
Tremfya contains polysorbate 80
This medicine contains 1 mg of polysorbate 80 in each pre-filled syringe which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Tremfya is given and for how long
Your doctor will decide for how long you need to use Tremfya.
Ulcerative colitis
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
Crohn’s disease
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.

You may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before use, which is included in the carton.
If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.
If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.
If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your 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 Tremfya and tell your doctor or seek medical help immediately if you get any of the following side effects:
Possible serious allergic reaction (may affect up to 1 in 1 000 people) - the signs or symptoms may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
- lightheadedness, low blood pressure, or dizziness
Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Very common (may affect more than 1 in 10 people)
- respiratory tract infections
Common (may affect up to 1 in 10 people)
- headache
- joint pain (arthralgia)
- diarrhoea
- increased level of liver enzymes in the blood
- skin rash
- redness, irritation or pain at the injection site
Uncommon (may affect up to 1 in 100 people)
- decreased number of a type of white blood cell called neutrophils
- herpes simplex infections
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- stomach flu (gastroenteritis)

- hives
Rare (may affect up to 1 in 1 000 people)
- allergic reaction
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 syringe label and on the outer carton after “EXP”. The expiry date refers to the last day of that month.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not shake.
Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles. Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes.
This medicine is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tremfya contains
- The active substance is guselkumab. Each pre-filled syringe contains 200 mg of guselkumab in 2 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections (see section 2 “Tremfya contains polysorbate 80”).
What Tremfya looks like and contents of the pack
Tremfya is a clear, colourless to light yellow solution for injection (injection). It is available in packs containing one pre-filled syringe and in multipacks comprising 2 cartons, each containing 1 pre-filled syringe. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333CB Leiden

The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11 janssen@jacbe.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0 800 086 9247 / +49 2137 955 6955 jancil@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
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.

Instructions for use
Tremfya
200 mg pre-filled syringe
SINGLE-USE DEVICE

Important
Tremfya comes in a single-use pre-filled syringe containing one 200 mg dose.
Your doctor will tell you if you will need to use 1 or 2 pre-filled syringes.
If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled syringe.
Please read these Instructions for Use before using the Tremfya pre-filled syringe and each time you get a refill. There may be new information. This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment. Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Each Tremfya pre-filled syringe can only be used one time. Throw the used pre-filled syringe away (see Step 4) after one dose, even if there is still medicine left in it. Do not reuse your Tremfya pre- filled syringe.
The Tremfya pre-filled syringe is intended for injection under the skin, not into the muscle or vein.
After injection, the needle will retract into the device and lock into place.
Storage information
Store in refrigerator at 2° to 8°C.
Do not freeze.
Do not shake your pre-filled syringe.
Keep your pre-filled syringe in the original carton to protect from light and physical damage.
Keep Tremfya and all medicines out of reach of children.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.

Pre-filled syringe at-a-glance
You will need:
- 1 or 2 pre-filled syringes based on the dose prescribed by your doctor
Not provided in the carton:
- Alcohol swabs
- Cotton balls or gauze pads
- Adhesive bandages
- Sharps container (See Step 4)
Before use
After use
Needle
Needle cover
Do not remove until you are ready to inject
(See Step 3)
Safety guard
Finger flange
Viewing window
Body
Plunger
Do not hold or pull plunger at any time.
Plunger stops
Safety guard activates
Needle retracts into the body

1. Get ready
Check your dose to see if you will need to use 1 or 2 pre-filled syringes and inspect carton(s) Remove the carton(s) with the pre-filled syringe from the refrigerator.
Check the expiry (‘EXP’) date.
Do not use the pre-filled syringe if the expiry date has passed or if the seal on the carton is broken.
Call your doctor or pharmacist for a new pre-filled syringe.
Allow Tremfya to come to room temperature
Let the carton(s) sit on a flat surface at room temperature for approximately 30 minutes before use.
Do not warm the pre-filled syringe(s) any other way.
200 mg
1 pre-filled syringe
400 mg
2 pre-filled syringes
WAIT
MIN

2. Prepare for your injection
Inspect liquid to see that it is clear to slightly yellow
Take the pre-filled syringe out of the carton.
Check the liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see air bubbles. This is normal.
Do not inject if the liquid is:
 cloudy or
 discoloured or
 has large particles
Do not use the pre-filled syringe if it is dropped.
If you are uncertain, call your doctor or pharmacist for a new pre-filled syringe.
Choose injection site
Select a site from the following areas for your injection:

Front of thighs

Lower stomach area (lower abdomen)
Do not use the 5-centimetre area around your belly-button

Back of upper arms (if a caregiver is giving you the injection)
If you need to give 2 injections to complete your dose, choose different areas or leave at least 5- centimetres between injection sites.
Do not inject into skin that is tender, bruised, red, scaly, thick or hard. Avoid areas with scars or stretch marks.

Wash hands and clean injection site
Wash your hands well with soap and warm water.
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after you have cleaned it.

3. Inject Tremfya using the pre-filled syringe
Remove needle cover when you are ready to inject
Hold the pre-filled syringe by the body and pull needle cover straight off.
It is normal to see a few drops of liquid.
Inject Tremfya within 5 minutes of removing the needle cover.
Do not put needle cover back on, as this may damage the needle or cause a needle stick injury.
Do not touch needle or let it touch any surface.
Do not use the pre-filled syringe if it is dropped. Call your doctor or pharmacist for a new pre-filled syringe.
Do not hold or pull the plunger at any time.
Pinch injection site and insert needle at about a 45-degree angle
It is important to pinch enough skin to inject under the skin and not into muscle.
Insert needle with a quick dart-like motion.

Slowly press plunger all the way down until it stops to inject all of the liquid You will feel some resistance as you press the plunger, this is normal.
Release pressure from plunger to remove the needle from the skin
The needle will retract into the device and lock into place.
If your prescribed dose requires two injections, repeat Steps 2 to 4 with the second pre-filled syringe.
SLOWLY

4. After your injection
Check injection site
There may be a small amount of blood or liquid at the injection site. Gently hold pressure over the injection site with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a bandage.
Your injection is now complete!
Throw away the used pre-filled syringe
Put the used pre-filled syringe in a sharps disposal container right away after use.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Do not throw away (dispose of) your pre-filled syringe in your household waste.
Do not recycle your used sharps disposal container.

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with ulcerative colitis and Crohn’s disease.
Ulcerative colitis
Tremfya is used to treat adults with moderate to severe ulcerative colitis, an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in ulcerative colitis can benefit you by reducing the signs and symptoms of the disease including bloody stools, the need to rush to and the number of times you go to the toilet, abdominal pain and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.
Crohn’s disease
Tremfya is used to treat adults with moderate to severe Crohn’s disease, an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Tremfya.
Using Tremfya in Crohn’s disease can benefit you by reducing the signs and symptoms of the disease such as diarrhoea, abdominal pain, and the inflammation of your intestinal lining. These effects can improve your ability to do normal daily activities and reduce fatigue.

Do not use Tremfya
 if you are allergic to guselkumab 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 Tremfya.
 if you have an active infection, including active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tremfya:
 if you are being treated for an infection;
 if you have an infection that does not go away or that keeps coming back;
 if you have tuberculosis or have been in close contact with someone with tuberculosis;
 if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions’);
 if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya.
As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Tremfya and when using it. Increases in liver enzymes may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see “How to use Tremfya” in section 3).
Look out for infections and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Tremfya.
Signs or symptoms of infections may include fever or flu like symptoms; muscle aches; cough;
shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body.
Serious allergic reactions have occurred with Tremfya. Symptoms may include, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, lightheadedness or dizziness, or hives (see “Serious side effects” in section 4).
Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Children and adolescents
Do not give this medicine to children and adolescents less than 18 years of age because it has not been studied in this age group.
Other medicines and Tremfya
Tell your doctor or pharmacist:
 if you are using, have recently used or might use any other medicines.
 if you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Pregnancy and breast-feeding

Tremfya should not be used in pregnancy as 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 Tremfya and for at least 12 weeks

after the last Tremfya 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 Tremfya.
Driving and using machines
Tremfya is unlikely to influence your ability to drive and use machines.
Tremfya contains polysorbate 80
This medicine contains 1 mg of polysorbate 80 in each pre-filled pen which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Tremfya is given and for how long
Your doctor will decide for how long you need to use Tremfya.
Ulcerative colitis
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.
Crohn’s disease
Treatment start:
Treatment start can be given either by intravenous infusion or by subcutaneous administration:

Intravenous infusion: The first dose of Tremfya is 200 mg and will be given by your doctor or nurse by intravenous infusion (drip in a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.

Subcutaneous administration: The first dose of Tremfya is 400 mg and will be given under the skin (subcutaneous injection) at different locations of the body. After the first dose, you will receive a second dose 4 weeks later and then a third dose after an additional 4 weeks.
Maintenance therapy:
A maintenance dose of Tremfya will be given by injection under the skin (subcutaneous injection) either with 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

A dose of 100 mg will be given 8 weeks after the third treatment start dose, and then every 8 weeks.

A dose of 200 mg will be given 4 weeks after the third treatment start dose and then every 4 weeks.

You may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use’ leaflet before use, which is included in the carton.
If you use more Tremfya than you should
If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.
If you forget to use Tremfya
If you have forgotten to inject a dose of Tremfya, inform your doctor.
If you stop using Tremfya
You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your 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 Tremfya and tell your doctor or seek medical help immediately if you get any of the following side effects:
Possible serious allergic reaction (may affect up to 1 in 1 000 people) - the signs or symptoms may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
- lightheadedness, low blood pressure, or dizziness
Other side effects
The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Very common (may affect more than 1 in 10 people)
- respiratory tract infections
Common (may affect up to 1 in 10 people)
- headache
- joint pain (arthralgia)
- diarrhoea
- increased level of liver enzymes in the blood
- skin rash
- redness, irritation or pain at the injection site
Uncommon (may affect up to 1 in 100 people)
- decreased number of a type of white blood cell called neutrophils
- herpes simplex infections
- fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
- stomach flu (gastroenteritis)

- hives
Rare (may affect up to 1 in 1 000 people)
- allergic reaction
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 pre-filled pen label and on the outer carton after “EXP”. The expiry date refers to the last day of that month.
Keep the pre-filled pen in the outer carton in order to protect from light.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not shake.
Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles. Before use, remove the carton from the refrigerator and keep the pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes.
This medicine is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tremfya contains
- The active substance is guselkumab. Each pre-filled pen contains 200 mg of guselkumab in 2 mL solution.
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections (see section 2 “Tremfya contains polysorbate 80”).
What Tremfya looks like and contents of the pack
Tremfya is a clear, colourless to light yellow solution for injection (injection). It is available in packs containing one pre-filled pen and in multipacks comprising 2 cartons, each containing 1 pre-filled pen.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333CB Leiden

The Netherlands
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11 janssen@jacbe.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0 800 086 9247 / +49 2137 955 6955 jancil@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
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.

Instructions for use
Tremfya
200 mg pre-filled pen
SINGLE-USE DEVICE

Important
Tremfya comes in a single-use pre-filled pen containing one 200 mg dose.
Your doctor will tell you if you will need to use 1 or 2 pre-filled pens.
If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled pen.
Please read these Instructions for Use before using the Tremfya pre-filled pen and each time you get a new pre-filled pen. There may be new information. This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment. Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Each Tremfya pre-filled pen can only be used one time. Throw the used pre-filled pen away (see Step 4) after one dose, even if there is still medicine left in it. Do not reuse your pre-filled pen.
Storage information
Store in refrigerator at 2° to 8°C.
Do not freeze.
Do not shake your pre-filled pen.
Keep your pre-filled pen in the original carton to protect from light and physical damage.
Keep Tremfya and all medicines out of reach of children.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.

Pre-filled pen at-a-glance
You will need:
- 1 or 2 pre-filled pens based on the dose prescribed by your doctor
Not provided in the carton:
- Alcohol swabs
- Cotton balls or gauze pads
- Adhesive bandages
- Sharps container (See Step 4)
Before use
Plunger rod fills the viewing window
After use
Viewing
Window
Yellow Needle
Guard
Thin Hidden
Needle
Cap
Do not remove until you are ready to inject
(See Step 3)

1. Get ready
Check your prescribed dose to see if you will need to use 1 or 2 pre-filled pens and inspect carton(s) Remove the carton(s) with the pre-filled pen from the refrigerator.
Check the expiry (‘EXP’) date on the carton.
Do not use the pre-filled pen if the expiry date has passed or if the seal on the carton is broken.
Call your doctor or pharmacist for a new pre-filled pen.
Allow Tremfya to come to room temperature
Let the carton(s) sit on a flat surface at room temperature for approximately 30 minutes before use.
Do not warm the pre-filled pen(s) any other way.
400 mg
2 pre-filled pens
200 mg
1 pre-filled pen
WAIT
MIN

2. Prepare for your injection
Inspect liquid in window to see that it is clear to slightly yellow
Take the pre-filled pen out of the carton.
Check the liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see air bubbles.
This is normal.
Do not inject if the liquid is:
 cloudy or
 discoloured or
 has large particles
If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
Choose injection site
Select from the following areas for your injection:

Front of thighs

Lower stomach area (lower abdomen)
Do not use the 5-centimetre area around your belly-button.

Back of upper arms (if a caregiver is giving you the injection)
If you need to give 2 injections to complete your dose, choose different areas or leave at least 5- centimetres between injection sites.
Do not inject into skin that is tender, bruised, red, scaly, thick or hard. Avoid areas with scars or stretch marks.

Wash hands and clean injection site
Wash your hands well with soap and warm water.
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after you have cleaned it.

3. Inject Tremfya using the pre-filled pen
Remove cap when you are ready to inject
Do Not Touch Yellow Needle Guard!
This may start the injection and you will not receive the dose.
Pull the cap straight off. It is normal to see a few drops of liquid.
Inject Tremfya within 5 minutes of removing cap.
Do not put the cap back on as this may damage the needle.
Do not use the pre-filled pen if it is dropped after removing the cap.
Call your doctor or pharmacist for a new pre-filled pen.
Position pre-filled pen straight onto the injection site then push and hold pre-filled pen Do Not Lift The Pre-Filled Pen During Injection!
If you do, the yellow needle guard will lock and the full dose will not be delivered.
Position the pre-filled pen straight onto the injection site with the yellow needle guard against the skin and the viewing window facing you.
Press down on the pre-filled pen and keep holding it down against the skin.
1st
CLICK!

You will hear the first click.
Keep holding the pre-filled pen firmly against the skin for about 10 seconds to hear a second click You are almost done.
Keep holding firmly against the skin and confirm the injection is complete
The injection is complete when the plunger rod stops moving and fills the viewing window.
SEC
2nd
CLICK!

Lift straight up
If your prescribed dose requires two injections, repeat Steps 2 to 4 with the second pre-filled pen.

4. After your injection
Check injection site
There may be a small amount of blood or liquid at the injection site. Gently hold pressure over the injection site with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a bandage.
Your injection is now complete!
Throw away the used pre-filled pen and cap
Put your used pre-filled pen and cap in a sharps disposal container right away after use.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Do not throw away (dispose of) your pre-filled pen in your household waste.
Do not recycle your used sharps disposal container.

infusion bag which is equal to the volume of Tremfya to be added.

0.9% Sodium Chloride Injection for a final concentration of 0.8 mg/mL. Gently mix the diluted solution. Discard the vial with any remaining solution.

Infuse the diluted solution over a period of at least one hour.

size 0.2 micrometre).

products.