Tremfya 200 mg PushPen solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tremfya is and what it is used for
2. What you need to know before you use Tremfya
3. How to use Tremfya
4. Possible side effects
5. How to store Tremfya
6. Contents of the pack and other information

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.

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.

• 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.

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).

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.

Tremfya is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.

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.

• 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.

Tremfya is unlikely to influence your ability to drive and use machines.

This medicine contains 1 mg of polysorbate 80 in each dosage unit which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Your doctor will decide for how long you need to use Tremfya.

Crohn’s disease

Treatment start can be given either by intravenous infusion or administered subcutaneously:

• 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.

Ulcerative Colitis

Treatment start:

• 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.

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 have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.

If you have forgotten to inject a dose of Tremfya, inform your doctor.

You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your symptoms may come back.

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 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

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

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
• redness, irritation or pain at the injection site

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

• allergic reaction

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 Yellow Card Scheme at: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

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.

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.

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.

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.

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)

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.

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
• discolored 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.

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.

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.

Lift straight up

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

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.