Tremfya 200 mg solution for injection in pre-filled pen: detailed information

Brand name Tremfya 200 mg solution for injection in pre-filled pen

Form solution for injection

Active substance / Dosage

GUSELKUMAB · 200 mg

Prescription type Hospital Diagnosis

ATC code

L04A L04AC L04AC16

Registration number 1171234008

Manufacturer Janssen-Cilag International N.V

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

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Tremfya is and what it is used for
2. What you need to know before using Tremfya
3. How to use Tremfya
4. Possible side effects
5. Storage of Tremfya
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

guselkumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

What Tremfya is and what it is used for
What you need to know before using Tremfya
How to use Tremfya
Possible side effects
How to store Tremfya
Contents of the pack and other information

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 in higher amounts in people with ulcerative colitis or Crohn's disease.

Ulcerative colitis

Tremfya is used to treat adults with moderately to severely active ulcerative colitis, an inflammatory bowel disease. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Tremfya may be given to you.

The use of Tremfya in ulcerative colitis may benefit you by reducing the signs and symptoms of the disease, including bloody stools, urgency and frequency of bowel movements, 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 moderately to severely active Crohn’s disease, an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Tremfya may be given to you.

The use of Tremfya in Crohn’s disease may benefit 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 using Tremfya

Do not use Tremfya

If you are allergic to guselkumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult 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 who has tuberculosis;
if you think you may have an infection or symptoms of an infection (see below “Monitoring for infections and allergic reactions”);
if you have recently been vaccinated or need to receive a vaccine during treatment with Tremfya.

If you are unsure whether any of the above conditions apply to you, speak with your doctor, pharmacist, or nurse before using Tremfya.

As directed by your doctor, before receiving Tremfya and while using it, you may need to have blood tests to check whether your liver enzymes are elevated. Increases in liver enzymes may be more common in patients receiving Tremfya every 4 weeks than in those receiving 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 adverse reactions, including allergic reactions and infections. You should monitor for signs of these conditions while receiving Tremfya.

Signs or symptoms of infection may include fever or flu-like symptoms; muscle aches; cough; difficulty breathing; burning sensation when urinating or urinating more frequently than usual; blood in phlegm (mucus); weight loss; diarrhea or stomach pain; skin that is warm, red, or painful, or sores on the body.

Serious allergic reactions have occurred with Tremfya. Symptoms may include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, feeling faint or dizzy, or hives (see “Serious adverse reactions” in section 4).

Stop using Tremfya and contact your doctor or seek medical help immediately if you notice any signs suggesting a possible serious allergic reaction or infection.

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age, as the medicine has not been studied in this age group.

Other medicines and Tremfya

Inform your doctor or pharmacist:

if you are using, have recently used, or might need to use any other medicines.
if you have recently been vaccinated or need to be vaccinated. You should not receive certain types of vaccines (live organism vaccines) while using Tremfya.

Pregnancy and breastfeeding

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

Driving and using machines

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

Tremfya contains polysorbate 80

This medicine contains 1 mg of polysorbate 80 in each pre-filled pen, equivalent to 0.5 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Tremfya

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

What dose of Tremfya to use and for how long

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

Ulcerative colitis

Initiation of treatment:

Treatment initiation can be done either via intravenous infusion or subcutaneous administration:

Intravenous infusion: the first dose of Tremfya is 200 mg, which will be administered by your doctor or nurse as an intravenous infusion (a 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, which will be administered under the skin (subcutaneous injection) at different sites on 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 by subcutaneous injection (injection under the skin) of either 100 mg or 200 mg. Your doctor will decide which maintenance dose you will receive:

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

You and your doctor may decide that you can self-inject Tremfya. In this case, you will receive appropriate training on how to inject Tremfya. Consult your doctor or nurse if you have any questions about how to give yourself an injection. It is important that you do not attempt to self-inject until you have been properly trained by your doctor or nurse.

For instructions on how to use Tremfya, carefully read the “Instructions for Use” leaflet provided inside the package.

If you use more Tremfya than you should

If you have received more Tremfya than you should, or if the dose was administered earlier than scheduled, 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

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

Stop using Tremfya and speak to your doctor or seek immediate medical help if you experience any of the following side effects:

Possible severe allergic reaction (may affect up to 1 in 1,000 people) – signs or symptoms may include:

difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
intense itching of the skin, with a red rash or raised bumps
dizziness, low blood pressure (hypotension), or lightheadedness

Other side effects

The following side effects are all mild to moderate. If any of these side effects become severe, consult 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 blood levels of liver enzymes
skin rash

Uncommon (may affect up to 1 in 100 people)

decrease in the number of a type of white blood cells called neutrophils
herpes simplex infections
fungal skin infections, for example 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 experience any type of side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tremfya

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the prefilled pen and on the outer packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store the prefilled pen in its outer packaging to protect it from light.

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

Do not shake.

Do not use this medicine if it appears cloudy or discoloured, or if it contains large particles. Before using the medicine, remove the pen from the refrigerator and allow it to reach room temperature while still in its packaging, waiting 30 minutes.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tremfya

The active substance is guselkumab. Each pre-filled pen contains 200 mg of guselkumab in 2 ml of solution.
The other components are histidine, histidine monochloride 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 transparent, injectable solution ranging from colourless to pale yellow. It is available in packs containing one pre-filled pen and in multipacks containing 2 packs, each with one pre-filled pen. Only certain 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium

Janssen-Cilag NV

Tel/Tel: +32 14 64 94 11