Tremfya ® 100 mg Solution

TREMFYA contains the active substance guselkumab which is a type of protein called a monoclonal antibody. This medicine works neutralising the activity of a protein called IL-23, which is present at increased levels in people with psoriasis.

Plaque psoriasis

TREMFYA is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails. TREMFYA can improve the skin clearance and nail appearance and reduce symptoms of psoriasis, such as scaling, shedding, flaking, itching, pain and burning. TREMFYA may improve your health-related quality of life.

Psoriatic arthritis

TREMFYA is used to treat adults with active psoriatic arthritis, an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will be given TREMFYA alone or in combination with a conventional Disease Modifying Anti- Rheumatic Drug (DMARD) such as methotrexate.

Do not use TREMFYA

• if you are hypersensitive (allergic) to guselkumab or any of the other ingredients in TREMFYA (listed in section 6).
• if you have clinically important active infections, irrespective of the pathogen.
• if you have active tuberculosis.
• if you are pregnant or breastfeed your infant.
• You should not be given live vaccines while using TREMFYA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using TREMFYA.

Infections

Before starting TREMFYA, tell your healthcare provider if you:

• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have tuberculosis (TB) or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection such as:
• fever or flu like symptoms
• blood in your phlegm (mucus)
• muscle aches
• weight loss
• cough
• diarrhoea or stomach pain
• shortness of breath
• warm, red, or painful skin or sores on your body different from psoriasis
• burning when you urinate or urinating more often than normal.

After starting TREMFYA, call your healthcare provider right away if you have any of the symptoms of infection listed above.

TREMFYA may lower your ability to fight infections and may increase your risk of infections. Do not use TREMFYA if you have any symptoms of infection unless you are instructed to by your healthcare professional.

Vaccinations:

Tell your doctor if you have recently had a vaccination or if you are due to have a vaccination during treatment with TREMFYA. You should not be given certain types of vaccines (live vaccines) while using TREMFYA. If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using TREMFYA.

Allergic reactions

Serious allergic reactions, which can include symptoms of a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, hives and shortness of breath, have occurred with TREMFYA. Tell your doctor or get emergency medical help right away if you think you are having an allergic reaction.

Children and adolescents

TREMFYA is not recommended for children and adolescents (younger than 18 years) because it has not been studied in this age group.

Other medicines and TREMFYA:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Pregnancy and Breastfeeding:

You must not become pregnant while receiving TREMFYA or for 12 weeks after your last treatment. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before using TREMFYA.

Contraception

If you are a woman of childbearing potential, use effective contraception while using TREMFYA and for at least 12 weeks after the last TREMFYA dose. Talk to your doctor about your contraception options.

Driving and using machines

It is not known if TREMFYA will affect the ability to drive or use machines.

TREMFYA contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using TREMFYA. TREMFYA contains sucrose which may have an effect on the control of your blood sugar if you have diabetes mellitus.

Do not share medicines prescribed for you with any other person.

Always use TREMFYA exactly as your doctor has told you. Check with your doctor if you are not sure.

TREMFYA is given by injection under your skin (subcutaneous injection). At the start of your therapy, TREMFYA may be injected by your healthcare provider. However, your healthcare provider may decide that it is right for you or your caregiver to learn how to inject TREMFYA under the skin (subcutaneously) yourself.

Before you self-inject TREMFYA, you must be trained by a healthcare professional. If you have not been trained, please contact your healthcare provider to schedule a training session. Call your healthcare provider if you have any questions about giving yourself an injection.

Before use, remove the carton from the refrigerator and keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes. Read Refer to the “Instructions for Use TREMFYA (Guselkumab) Prefilled Syringe and/or Prefilled Pen” for the syringe carefully before using TREMFYA.

How much TREMFYA is given and for how long

Your doctor will decide how much TREMFYA you need and for how long. Do not stop treatment early because your symptoms may return. If you have the impression that the effect of TREMFYA is too strong or too weak, tell your doctor or pharmacist.

For plaque psoriasis:

• The first dose is 100 mg (the content of 1 pre-filled syringe or pre-filled pen) by subcutaneous injection. This may be given by your doctor or nurse.
• After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks. The following doses are the same as the first dose.

For psoriatic arthritis:

• The first dose is 100 mg (the content of 1 pre-filled syringe or pre-filled pen) by subcutaneous injection. This may be given by your doctor or nurse.
• After the first dose, you will have the next dose 4 weeks later, followed by a dose either every 8 weeks or 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 sooner than prescribed, inform your doctor. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use TREMFYA

If you forget to inject your TREMFYA dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Do not take a double dose to make up for forgotten individual doses. If you are not sure what to do, contact your doctor.

If you stop using TREMFYA

You should not stop using TREMFYA without speaking to your doctor first. If you stop treatment, your symptoms may come back.

TREMFYA can cause side effects. Not all side effects reported for TREMFYA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving TREMFYA, please contact your health care provider for advice.

Frequently reported side effects

• infections of the nose, sinuses or throat (common cold), chest infection
• stomach flu (gastroenteritis)
• fungal infection of the skin, for example between the toes (athlete's foot)
• herpes simplex infections, for example of the lips (cold sores) or genitals (genital herpes)
• headache
• diarrhoea
• joint pain
• redness, pain and irritation at the injection site
• allergic reaction
• skin rash
• hives
• decreased number of a type of white blood cell called neutrophils
• increased level of liver enzymes in the blood.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TREMFYA.

Store all medicine out of reach of children. If you are using TREMFYA at home, it is important to store the product in your refrigerator (2 ºC – 8 ºC) and not in the freezer compartment. TREMFYA should not be frozen. Keep the product in the original carton to protect from light until the time of use. Do not shake the product.

Do not use TREMFYA:

• After the expiry date, which is stated on the label and the carton after “EXP”. The expiry date refers to the last day of that month;
• If the seal is broken;
• If the liquid is discoloured, cloudy or you can see other particulate matter floating in it.

How to Dispose of TREMFYA

• Used syringes and pens should be placed in a puncture-resistant container, like a sharps container.
• Return your full sharps container to your doctor or local pharmacy for destruction.
• Empty vials, antiseptic wipes, and other supplies can be placed in your regular trash.

The pre-filled syringe and/or pre-filled pen, must never be re-used.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).