Tremfya 100 mg solution for injection in pre-filled syringe: detailed information

Brand name Tremfya 100 mg solution for injection in pre-filled syringe

Form solution for injection in a pre-filled syringe

Active substance / Dosage

GUSELKUMAB · 105 mg

Prescription type Hospital Diagnosis

ATC code

L04A L04AC L04AC16

Registration number 1171234001

Manufacturer Janssen-Cilag International N.V

Tremfya 100 mg solution for injection in pre-filled syringe solution for injection in a pre-filled syringe

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 100 mg solution for injection in pre-filled syringe

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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, talk to your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.

Plaque psoriasis

Adults

Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory disorder affecting the skin and nails.

Tremfya can improve skin conditions and the appearance of nails, and reduces symptoms such as scaling, flaking, peeling, itching, pain, and burning.

Children

Tremfya is used to treat children from 6 years of age with moderate to severe “plaque psoriasis”, an inflammatory disorder affecting the skin.

Tremfya can improve skin conditions and reduce signs and symptoms such as scaling and redness.

Psoriatic arthritis

Tremfya is used to treat a disease called “psoriatic arthritis”, an inflammatory joint disease, often accompanied by plaque psoriasis. If you have psoriatic arthritis, you will first be given other medicines. If you do not respond adequately to these medicines or if you are intolerant to them, Tremfya will be given to reduce the signs and symptoms of your disease. Tremfya can be used alone or in combination with another medicine called methotrexate.

The use of Tremfya in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down cartilage and bone damage in the joints, and improving your ability to perform normal daily activities.

Ulcerative colitis

Tremfya is used to treat adults with moderate to severe 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 to go to the bathroom, increased frequency of bowel movements, abdominal pain, and inflammation of the intestinal lining. These effects may improve your ability to perform normal daily activities and reduce fatigue.

Crohn’s disease

Tremfya is used to treat adults with moderate to severe 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 perform 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 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 infection or one that has recurred;
if you have tuberculosis or have had 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. Children should be up to date with age-appropriate vaccinations before
starting 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 occur more frequently 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 that are different from psoriasis lesions.

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 lightheadedness, 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 severe allergic reaction or infection.

Children and adolescents

Do not administer this medicine to children under 6 years of age with plaque psoriasis or to children under 18 years of age with psoriatic arthritis, ulcerative colitis, or Crohn’s disease, as it has not been studied in these age groups.

Other medicines and Tremfya

Inform your doctor or pharmacist:

if you are taking, have recently taken, or might need to take 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.

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 operate machinery.

Tremfya contains polysorbate 80

This medicine contains 0.5 mg of polysorbate 80 in each pre-filled syringe, 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 administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

How much Tremfya to administer and for how long

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

Plaque psoriasis

Adults:

The dose is 100 mg (the contents of 1 pre-filled syringe) administered as an injection under the skin (subcutaneous injection). Your doctor or nurse will likely administer this injection.
After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks.

Children:

For children weighing 40 kg or more, the dose is 100 mg (the contents of 1 pre-filled syringe) administered as an injection under the skin (subcutaneous injection). Your doctor or nurse will likely administer this injection.
For children weighing less than 40 kg, a 45 mg/0.45 mL pre-filled pen is available.
After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks.

Psoriatic arthritis

The dose is 100 mg (the contents of 1 pre-filled syringe) administered as an injection under the skin (subcutaneous injection). Your doctor or nurse will likely administer this injection.
After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks. In some patients, after the first dose, Tremfya may be administered every 4 weeks. Your doctor will decide how frequently you can receive Tremfya.

Ulcerative colitis

Induction of treatment:

Treatment initiation can be performed either by intravenous infusion or subcutaneous administration:

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

You will receive a dose of 100 mg 8 weeks after the third induction dose, and then every 8 weeks.
You will receive a dose of 200 mg 4 weeks after the third induction dose, and then every 4 weeks.

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 self-administer the injection. It is important that you do not attempt to self-inject until your doctor or nurse has trained you.

Children under 18 years of age must not self-inject Tremfya. Your doctor may decide that your caregiver can administer Tremfya after receiving appropriate training on how to inject Tremfya.

For instructions on how to use Tremfya, carefully read the “Instructions for use” leaflet included in the package before using the medicine.

If you use more Tremfya than you should

If you have received more Tremfya than prescribed or 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 using 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
severe itching of the skin, with red rash or lumps
dizziness, low blood pressure (hypotension), or feeling faint

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 levels in blood of liver enzymes
skin rash
redness, irritation, or pain at the injection site

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 infection, for example between the toes (e.g., athlete’s foot)
stomach upset (gastroenteritis)
hives

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

allergic reaction

Reporting of side effects

If you experience any kind 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 syringe and on the outer packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store the pre-filled syringe 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 administering the medicine, remove the container from the refrigerator and allow the pre-filled syringe to reach room temperature while remaining in its packaging for approximately 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 containers 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 syringe contains 100 mg of guselkumab in 1 ml of solution.
The other components are histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, and water for injections (see section 2 “Tremfya contains polysorbate 80”).

Appearance of Tremfya and contents of the pack

Tremfya is a transparent, colourless to pale yellow injectable solution. It is available in packs containing one pre-filled syringe and in multiple packs containing 2 packs, each pack containing one pre-filled syringe. 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 more information about this medicine, you can contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium

Janssen‑Cilag NV

Tel/Tel: +32 14 64 94 11