Tremfya - patient leaflet, side effects, dosage

1. What Tremfya is and what it is used for

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 and psoriatic arthritis.

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 psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, 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.

2. What you need to know before you use Tremfya

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. 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.

Signs 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, which can include the following symptoms, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing and hives, have occurred with Tremfya (see “Serious side effects” in section 4).

Children and adolescents

Tremfya is not recommended for children and adolescents under 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.

3. How to use Tremfya

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse 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 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.

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.

At the start, your doctor or nurse will inject Tremfya. However, 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.

4. Possible side effects

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

Serious side effects

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 100 people) – the signs 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

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.

Some side effects are very common (may affect more than 1 in 10 people): – respiratory tract infections

Some side effects are common (may affect up to 1 in 10 people):

• – headache

• – joint pain (arthralgia)

• – diarrhoea

• – redness, irritation or pain at the injection site

• – increased level of liver enzymes in the blood

Some side effects are uncommon (may affect up to 1 in 100 people):

• – allergic reaction

• – skin rash

• – 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

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.

5. How to store Tremfya

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 it 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.

6. Contents of the pack and other information

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,

sucrose and water for injections.

What Tremfya looks like and contents of the pack

Solution for injection (injection). Tremfya is a clear, colourless to light yellow solution. It is supplied as a carton pack containing one single-dose glass syringe and as a multipack containing 2 (2 packs of 1) single-dose pre-filled syringes. 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

Authorisation Holder:

Belgie/Belgiqu­e/Belgien

Janssen-Cilag NV

Tel/Tél: +32 14 64 94 11

Efcnrapua

..^■/KOHCbH & ^>KOHCbH Ebnrapua” EOOfl

Ten.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o.

Tel.: +420 227 012 227

Danmark

Janssen-Cilag A/S Tlf: +45 45 94 8282

Deutschland

Janssen-Cilag GmbH Tel: +49 2137 955 955

Eesti UAB „JOHNSON & JOHNSON“ Eesti filiaal Tel: +372 617 7410	Norge Janssen-Cilag AS Tlf: +47 24 12 65 00
EXÀàôa Janssen-Cilag OappaKsuTiK^ A.E.B.E. Tql: +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	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	Portugal Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700	România Johnson & Johnson România SRL Tel: +40 21 207 1800
Ireland Janssen Sciences Ireland UC Tel: +353 1 800 709 122	Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
Ísland Janssen-Cilag AB c/o Vistor hf. Sími: +354 535 7000	Slovenská republika Johnson & Johnson, s.r.o. Tel: +421 232 408 400
Italia Janssen-Cilag SpA Tel: 800.688.777/+39 02 2510 1	Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 300
Kùnpoç Bapváßaç XaTZnnavaY^ç Ató TnX: +357 22 207 700	Sverige Janssen-Cilag AB Tel: +46 8 626 50 00
Latvija UAB „JOHNSON & JOHNSON“ filiale Latvijä Tel: +371 678 93561	United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 444

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

Instructions for use

Tremfya

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.

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.

Store in refrigerator at 2° to 8°C. Do not freeze.

Keep Tremfya and all medicines out of reach of children.

Do not shake the pre-filled syringe at any time.

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).

Plunger locks

Safety guard activates

Needle retracts into the body

You will need these supplies:

• 1 Alcohol swab
• 1 Cotton ball or gauze pad
• 1 Adhesive bandage
• 1 Sharps container (See Step 3)

• 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 expiration date (‘EXP’) on the back panel of the carton.

Do not use if the expiration 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.

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