TREMFYA 100 Prefilled Syringe mg/ml (Refrigerator)

Product Description:

• 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, of which there are elevated levels in people with psoriasis and psoriatic arthritis.

Flapper

• Tremfya is used to treat adults with moderate to severe 'plaque psoriasis', an inflammatory condition affecting the skin and nails.
• Tremfya can improve the condition of the skin and the appearance of the nails and reduce symptoms, such as scaling, flaking, flakes, itching, pain and burning.

Psoriatic arthritis

• Tremfya is used to treat a condition called 'psoriatic arthritis', an inflammatory disease of the joints, which is often accompanied by plaque psoriasis.
• If you have psoriatic arthritis, you will first receive other medicines.
• If you do not get a good enough effect from these medicines or in case of intolerance, you will receive Tremfya to reduce the signs and symptoms of the disease. 
• Tremfya can be used alone or together with another medicine called methotrexate.
• Using Tremfya for psoriatic arthritis will help you in that it reduces the signs and symptoms of the disease, slows down damage to joint cartilage and bones and improves your ability to carry out normal everyday activities.

How To Use:

• Always use this medicine exactly as your doctor has told you.
• Contact a 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.

Flapper

• The dose is 100 mg (the contents of 1 pre-filled syringe) given by injection under the skin ( subcutaneous injection). This can be given by a doctor or a nurse.
• After the first dose, you get the next dose after 4 weeks and then every 8 weeks.

Psoriatic arthritis

• The dose is 100 mg (the contents of 1 pre-filled syringe) given by injection under the skin ( subcutaneous injection). This can be given by a doctor or a nurse.
• After the first dose, you get the next dose after 4 weeks and then every 8 weeks. In some patients, after the first dose, Tremfya can be given every 4 weeks. Your doctor will decide how often you can receive Tremfya.

• At first, the doctor or a nurse will inject Tremfya. 
• However, you can arrange with the doctor that you take Tremfya yourself. 
• In this case, you will receive the necessary training on how to inject Tremfya. 
• Talk to your doctor or nurse if you have any questions about how to give yourself an injection.
• It is important not to try to inject yourself until you have received training from a doctor or nurse.
• For detailed instructions on how to use Tremfya, read the "Instructions for Use" enclosed in the box carefully before use.

If you take too much Tremfya:

• Inform the doctor if you have received too much Tremfya or the dose has been given earlier than prescribed.

If you have forgotten to take Tremfya:

• Tell your doctor if you have forgotten to inject a dose of Tremfya.

If you stop treatment with Tremfya:

• You should not stop treatment with Tremfya without talking to your doctor first. 
• If you stop the treatment, the symptoms may return.
• Ask your doctor, pharmacist or nurse if you have any questions about the use of this medicine.

Warnings and precautions:

Do not use Tremfya:

• If you are allergic to guselkumab or any of the other ingredients of this medicine. 
• Talk to your doctor before using tremfya if you think you may be allergic.
• 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 "Be aware of infections and allergic reactions ")
• If you have recently been vaccinated or if you are to be vaccinated during treatment with Tremfya.
• Talk to your doctor, pharmacist or nurse before using Tremfya if you are unsure whether any of the above applies to you.
• Your doctor will consider whether you need to have blood tests to check if you have high levels of liver enzymes before you start Tremfya and while you are using it.
• Liver enzyme elevations may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks.

Be aware of infections and allergic reactions:

• Tremfya can possibly cause serious side effects, including allergic reactions and infections . 
• You need to be aware of signs of such conditions while taking Tremfya.
• Signs of infection may include fever or flu-like symptoms; muscle aches; reap; shortness of breath; burning when urinating or urinating more frequently than usual; blood in mucus; weight loss; diarrhea or abdominal pain; hot, red or sore skin or sores on the body that are different from your psoriasis.
• Serious allergic reactions , which may include the following symptoms, swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing and hives , have occurred with Tremfya.
• Discontinue treatment with Tremfya and talk to your doctor or see a healthcare professional immediately if you notice signs that suggest a possible serious allergic reaction or an infection .

Children and youth

• Tremfya is not recommended for children and adolescents under the age of 18 as it has not been studied in this age group.

Talk to your doctor or pharmacist:

• If you use, have recently used or plan to use other medicines.
• If you have recently been vaccinated or are about to be vaccinated. There are some types of vaccines (live vaccines) that you should not receive 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 potential, you must avoid becoming pregnant, and you must use effective 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 plan to become pregnant.
• Talk to your doctor if you are breastfeeding or plan to breastfeed. 
• You and the doctor should agree whether you should breastfeed or use Tremfya.

Driving and using machines

• Tremfya is unlikely to affect your ability to drive and use machines.

Ingredients:

• The active substance is guselkumab. Each pre-filled syringe contains 100 mg of guselkumab in 1 ml of solution.

What Tremfya looks like and contents of the pack:

• Tremfya is a clear, colorless to slightly yellow solution for injection.
• It is available in packs containing one pre-filled syringe and in multipacks of 2 boxes, each containing 1 pre-filled syringe. Not all pack sizes will necessarily be marketed.