100 mg solution for injection in pre-filled pen guselkumab
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 that occurs at elevated levels in people with psoriasis and psoriatic arthritis.
Plaque psoriasis
Tremfya is used to treat adults with moderate to severe ‘plaque psoriasis, an inflammatory disease that affects the skin and nails.
Tremfya can improve the condition of the skin and the appearance of the nails and reduce symptoms such as scaling, skin irritation, flaking, itching, pain, and burning.
Psoriatic arthritis
Tremfya is used to treat a condition called psoriatic arthritis, an inflammatory disease of the joints that is often accompanied by plaque psoriasis. If you have psoriatic arthritis, you will first receive other medicines. If these medicines do not work well enough or in case of intolerance, you will be given Tremfya to reduce the signs and symptoms of the disease. Tremfya can be used alone or with another medicine called methotrexate.
Using Tremfya for psoriatic arthritis reduces the signs and symptoms of the disease, slows down the damage to the cartilage and bone in the joints, and improves your ability to carry out normal activities.
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). Consult a doctor before using Tremfya if you think you may be allergic.
- if you have an active infection, including active tuberculosis.
Warnings and precautions
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 is recurrent
- if you have tuberculosis or have been in close contact with someone who has tuberculosis
- if you think you have an infection or have symptoms of an infection (see below under “Be aware of the infection and allergic reactions”)
- if you have recently received a vaccination or if you have a planned vaccination during treatment with Tremfya.
Talk to your doctor, pharmacist, or nurse before using Tremfya if you are not sure if any of the above apply to you.
You may need blood tests to check if you have high levels of liver enzymes before you start Tremfya and while you are using it. Your doctor will decide on this. Elevated liver enzymes may occur more often in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see “How to use Tremfya” in section 3).
Be aware of the infection and allergic reactions
Tremfya can potentially cause serious side effects, including allergic reactions and infection. You need to be alert for signs of these conditions while taking Tremfya.
Signs of infection may include fever or flu-like symptoms; muscle pain; cough; shortness of breath; burning sensation when you urinate or that you urinate more often than usual; blood in expectoration (phlegm); weight loss; diarrhea or stomach pain; hot, red, or painful skin or sores on the body that are different from your psoriasis.
Serious allergic reactions, which may include symptoms such as swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing and hives, have occurred with Tremfya (see “Serious side effects” in section 4).
Stop using Tremfya and tell the doctor or seek medical attention immediately if you observe any signs of a possible serious allergic reaction or an infection.
Children and young people
Tremfya is not recommended for children and adolescents under 18 years of age as it has not been studied in this age group.
Other medicines and Tremfya
Tell your doctor or pharmacist:
- if you are using, have recently used, or may be using other medicines
- if you have recently received or are about to receive a vaccination. 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 on pregnant women are not known. If you are a woman of childbearing potential, it is recommended that you avoid becoming pregnant and you must use adequate contraception while using Tremfya and for at least 12 weeks after the last dose of Tremfya. 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 breastfeeding or plan to breastfeed. You and your doctor should decide whether you should breastfeed or use Tremfya.
Driving ability and use of machinery
Tremfya is unlikely to affect your ability to drive or use machines.
How to use Tremfya
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much Tremfya is given and for how long
Your doctor will decide how long you need to use Tremfya.
Plaque psoriasis
- Dose one is 100 mg (the content of 1 pre-filled injection pen ) and is given by injection under the skin ( subcutaneous injection ). It can be given by a doctor or nurse.
- You will receive the next dose 4 weeks after the first dose, and then every 8 weeks.
Psoriatic arthritis
- Dose one is 100 mg (the content of 1 pre-filled injection pen ) and is given by injection under the skin ( subcutaneous injection ). It can be given by a doctor or nurse.
- You will receive the next dose 4 weeks after the first dose, and then every 8 weeks. In some patients, Tremfya can be given every 4 weeks, after the first dose. Your doctor will decide how often you can receive Tremfya.
In the beginning, the doctor or nurse will inject Tremfya, but you can decide together with your doctor to give Tremfya yourself. If so, you will receive the necessary training on how to inject Tremfya. Talk to the doctor or nurse if you have any questions about giving yourself an injection. You mustn’t try to inject yourself until you have been trained by a doctor or nurse.
Carefully read the “Handling instructions” leaflet, which is supplied in the box, before using it for detailed instructions on how to use Tremfya.
If you have used too much Tremfya
Inform the doctor if you have received too much Tremfya or if a dose has been given earlier than prescribed.
If you forget to use Tremfya
Tell your doctor if you forget to inject a dose of Tremfya.
If you stop using Tremfya
You should not stop using Tremfya without first talking to your doctor. If you stop treatment, symptoms may return.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Tell your doctor or seek medical attention immediately if you experience any of the following side effects:
Possible serious allergic reaction (may affect up to 1 in 100 users) – symptoms may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue, or throat
- severe skin itching, with red rashes or raised nodules
Other side effects are
All of the following side effects are mild to moderate. Tell your doctor, pharmacist, or nurse immediately if any of these side effects become serious.
Very common (may affect more than 1 in 10 users)
- respiratory tract infections
Common (may affect up to 1 in 10 users)
- headache
- joint pain ( arthralgia )
- diarrhea
- redness, irritation, or pain at the injection site
- elevated liver enzymes in the blood
Uncommon (may affect up to 1 in 100 users)
- allergic reaction
- rash
- reduced number of a type of white blood cell called neutrophils
- herpes simplex infection _
- fungal infection of the skin, e.g. between the toes (e.g. athlete’s foot )
- stomach ailment ( gastroenteritis )
- hives
How to store Tremfya
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the pre-filled pen label and the outer carton after ‘EXP’. The expiration date is the last day of the specified month.
Store the pre-filled pen in the outer carton. Light sensitive.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Must not be shaken.
Do not use this medicine if the medicine is cloudy or discolored or contains large particles. Remove the carton from the refrigerator and leave the pre-filled pen in the carton for 30 minutes to reach room temperature before use.
This medicine is for single use only. Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is guselkumab. Each pre-filled pen contains 100 mg of guselkumab in 1 ml of solution.
- Other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.
Appearance and package sizes of the medicine
Tremfya is a clear, colorless pale yellow solution for injection ( solution for injection ). It is supplied in packs containing one pre-filled pen and in multipacks consisting of 2 cartons, each containing 1 pre-filled pen.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics BV
Einsteinweg 101
2333CB Leiden
Netherlands