Tremfya 200 mg concentrate for solution for infusion

• 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 moderate to severe ulcerative colitis in adults, 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 10 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.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

However, before Tremfya is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.

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:

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.

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 vial contains 200 mg of guselkumab in 20 mL solution.
• The other ingredients are EDTA disodium dihydrate, histidine, histidine monohydrochloride monohydrate, methionine, polysorbate 80 (E433), sucrose and water for injections.

Tremfya is a clear, colourless to light yellow solution for infusion.

Each pack contains 1 vial.