TREMFYA 200 mg CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Tremfya 200 mg concentrate for solution for infusion

guselkumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What is Tremfya and what is it 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 in higher amounts in people with ulcerative colitis or Crohn's disease.

Ulcerative Colitis

Tremfya is used to treat adults with moderate to severe ulcerative colitis, an inflammatory disease of the intestine. 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 for ulcerative colitis may help you by reducing the signs and symptoms of the disease, including bloody stools, the need to go to the toilet urgently, and the number of times you go, abdominal pain, and inflammation of the intestinal lining. These effects may improve your ability to carry out 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 intestine. 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 for Crohn's disease may help you by reducing the signs and symptoms of the disease, such as diarrhea, abdominal pain, and inflammation of the intestinal lining. These effects may improve your ability to carry out normal daily activities and reduce fatigue.

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, talk to your doctor before using Tremfya.
• If you have an active infection, including active tuberculosis.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Tremfya:

• if you are being treated for an infection;
• if you have a persistent or recurring infection;
• if you have tuberculosis or have been in close contact with someone with tuberculosis;
• if you think you have an infection or symptoms of an infection (see below “Monitoring for infections and allergic reactions”);
• if you have recently been vaccinated or are about to be vaccinated. You should not receive certain types of vaccines (live vaccines) while using Tremfya.

If you are not sure if any of the above conditions apply to you, talk to your doctor, pharmacist, or nurse before using Tremfya.

Following the advice of your doctor, before receiving Tremfya and when you are going to use it, you may need to have blood tests to check if you have elevated levels of liver enzymes. Increases in liver enzymes may be more frequent in patients who receive Tremfya every 4 weeks than in those who receive Tremfya every 8 weeks (see “How to use Tremfya” in section 3).

Monitoring for infections and allergic reactions

Tremfya has the potential to cause serious side effects, including allergic reactions and infections. You should monitor for signs of these disorders while receiving Tremfya.

Signs or symptoms of infection may include fever or flu-like symptoms; muscle pain; cough; difficulty breathing; burning when urinating or urinating more frequently than usual; blood in the sputum; weight loss; diarrhea or stomach pain; hot, red, or painful skin, or sores on the body.

Severe allergic reactions have occurred with Tremfya. Symptoms may include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, dizziness or fainting, or hives (see “Serious side effects” in section 4).

Stop using Tremfya and talk to your doctor or seek medical help immediatelyif you notice any sign that may indicate a serious allergic reaction or infection.

Children and adolescents

Tremfya is not recommended for use in children and adolescents under 18 years of age because there are no studies 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 have recently been vaccinated or need to be vaccinated. You should not receive certain types of vaccines (live vaccines) while using Tremfya.

Pregnancy and breastfeeding

• Tremfya should not be used during pregnancy as the effects of this medicine in pregnant women are not known. If you are a woman of childbearing age, you are advised to avoid becoming pregnant and to use an adequate method of contraception during treatment with Tremfya and for at least 12 weeks after the last dose of Tremfya. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether you can breastfeed or use Tremfya.

Driving and using machines

Tremfya is unlikely to affect your ability to drive or use machines.

Tremfya contains polysorbate 80

This medicine contains 10 mg of polysorbate 80 in each vial, equivalent to 0.5 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Tremfya contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

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

3. How to use Tremfya

Tremfya is intended for use under the guidance and supervision of a doctor with experience in the diagnosis and treatment of ulcerative colitis.

How much Tremfya to use and for how long

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

Ulcerative Colitis

Starting treatment:

• The first dose of Tremfya is 200 mg and will be given to you by your doctor or nurse through an intravenous infusion (drip into a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and a third dose 4 weeks after that.

Maintenance treatment:

You will be given a maintenance dose of Tremfya through a subcutaneous injection (under the skin) of 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

• You will be given a dose of 100 mg 8 weeks after the third starting dose, and then every 8 weeks.
• You will be given a dose of 200 mg 4 weeks after the third starting dose, and then every 4 weeks.

Crohn's Disease:

Starting treatment:

Treatment may be started through intravenous infusion or subcutaneous administration:

• Intravenous infusion: the first dose of Tremfya is 200 mg and will be given to you by your doctor or nurse through an intravenous infusion (drip into a vein in your arm). After the first dose, you will receive a second dose 4 weeks later and a third dose 4 weeks after that.
• Subcutaneous administration: the first dose of Tremfya is 400 mg and will be given to you under the skin (subcutaneous injection) in different parts of the body. After the first dose, you will receive a second dose 4 weeks later and a third dose 4 weeks after that.

Maintenance treatment:

You will be given a maintenance dose of Tremfya through a subcutaneous injection (under the skin) of 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

• You will be given a dose of 100 mg 8 weeks after the third starting dose, and then every 8 weeks.
• You will be given a dose of 200 mg 4 weeks after the third starting dose, and then every 4 weeks.

If you use more Tremfya than you should

If you have received more Tremfya than you should or the dose has been given before the scheduled time, tell your doctor.

If you forget to use Tremfya

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

If you stop using Tremfya

Do not stop using Tremfya without talking to your doctor first. If you stop treatment, your symptoms may return.

If you have any other questions about using this medicine, ask your doctor, pharmacist, or nurse.

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 serious side effects:

Severe 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 lumps
• dizziness, low blood pressure (hypotension), or fainting

Other side effects

The following side effects are all mild to moderate. If any of these side effects gets serious, talk to 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)
• diarrhea
• increased liver enzymes in the blood
• skin rash

Uncommon(may affect up to 1 in 100 people)

• decrease in the number of a type of white blood cell called neutrophils
• herpes simplex infections
• fungal skin infections, e.g., between the toes (e.g., athlete's foot)
• stomach upset (gastroenteritis)
• hives
• redness, irritation, or pain at the injection site

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.

5. Storing Tremfya

Tremfya 200 mg concentrate for solution for infusion is administered in a hospital or clinic, and patients should not store or handle it.

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 label and carton after “EXP”. The expiry date is the last day of the month stated.

Store the vial in the outer carton to protect it from light.

Store in a refrigerator (2°C and 8°C). Do not freeze.

Do not shake.

Do not use this medicine if you notice it is cloudy or has changed color, or contains large particles.

This medicine is for single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Tremfya composition

• The active substance is guselkumab. Each vial contains 200 mg of guselkumab in 20 ml of solution.
• The other components are disodium edetate dihydrate (E385), histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80 (E433), sucrose, and water for injectable preparations.

Appearance and container contents of the product

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

Each container contains 1 vial.

Marketing authorization holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333CB Leiden

Netherlands

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Tremfya 200 mg concentrated solution for infusion

guselkumab

This information is intended for healthcare professionals only.

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Tremfya 200 mg/20 ml (10 mg/ml) vial for intravenous infusion

Tremfya solution for infusion should be diluted, prepared, and infused by a healthcare professional using aseptic technique. Tremfya does not contain preservatives. Each vial is for single use only.

Inspect Tremfya visually for particles and discoloration before administration. Tremfya is a clear, colorless to light yellow solution that may contain small translucent particles. Do not use if the liquid contains large particles, is discolored, or is turbid.

Dilution and administration instructions

Add Tremfya to a 250 ml intravenous infusion bag of sodium chloride 0.9% injectable as follows:

1. Withdraw and then discard 20 ml of sodium chloride 0.9% injectable from the 250 ml infusion bag, which is equal to the volume of Tremfya to be added.
2. Withdraw 20 ml of Tremfya from the vial and add it to the 250 ml intravenous infusion bag of sodium chloride 0.9% injectable to obtain a final concentration of 0.8 mg/ml. Gently mix the diluted solution. Discard the vial with the remaining solution.
3. Inspect the diluted solution visually for particles and discoloration before infusion. Infuse the diluted solution over at least one hour.
4. Use only an infusion set with an in-line filter, sterile, non-pyrogenic, and low protein-binding (pore size 0.2 microns).
5. Do not infuse Tremfya concomitantly via the same intravenous line with other medicinal products.
6. Dispose of unused medicinal product and all materials that have come into contact with it in accordance with local regulations.