Tremfya 100mg Injection is used for:

• Moderate-to-severe plaque psoriasis: Used in eligible patients who may require systemic treatment or phototherapy.

• Active psoriatic arthritis: Helps reduce inflammation and symptoms affecting the joints and skin.

• Moderately to severely active ulcerative colitis: Used as part of treatment for adults with active disease.

• Moderately to severely active Crohn's disease: Used as part of treatment for adults with active disease.

The approved uses and dosing schedule may vary according to the country, indication and specific product presentation.

Tremfya contains Guselkumab, which is an interleukin-23 (IL-23) antagonist.

IL-23 is an immune signalling protein involved in maintaining inflammation in conditions such as psoriasis and psoriatic arthritis and in inflammatory bowel disease. Guselkumab binds to IL-23 and blocks its activity, helping reduce the inflammatory response associated with these conditions.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• CYP450 medicines: Guselkumab may alter the activity of certain CYP450 enzymes when inflammation is reduced. Your doctor may monitor medicines with a narrow therapeutic range and adjust their dose if required.

• Live vaccines: Avoid live vaccines while receiving Tremfya. Complete age-appropriate vaccinations before starting treatment when possible.

• Other medicines affecting the immune system: Tell your doctor if you are receiving other biologic or immunosuppressive treatments so your treatment can be reviewed for infection risk.

• Store Tremfya in a refrigerator at 2°C to 8°C.

• Keep it in the original carton until use to protect it from light.

• Do not freeze.

• Do not shake.

• Tremfya is preservative-free and unused product should be discarded.

Tremfya 100mg Injection is administered by subcutaneous injection under the guidance of a healthcare professional.

For plaque psoriasis and psoriatic arthritis, the commonly recommended adult regimen is 100mg at Week 0, Week 4 and every 8 weeks thereafter. For ulcerative colitis and Crohn's disease, the treatment schedule is different and may include higher induction doses before 100mg maintenance dosing. Follow the regimen prescribed for your condition.

After appropriate training, some adults may self-administer Tremfya using the prescribed injection device. Do not attempt self-injection until your healthcare professional has shown you how to use the specific device supplied with your medicine.

Common side effects may include:

• Upper respiratory tract infections

• Headache

• Injection-site reactions

• Joint pain

• Bronchitis

• Diarrhoea

• Gastroenteritis

• Fungal skin infections

• Herpes simplex infections

• Abdominal pain

• Fatigue

• Fever

• Rash

Serious side effects:

• Serious infections, particularly in people who develop an infection while receiving treatment.

• Tuberculosis: Screening for TB is recommended before starting treatment.

• Serious hypersensitivity reactions, including anaphylaxis.

• Drug-induced liver injury: Seek medical attention for yellowing of the skin or eyes, dark urine, severe abdominal pain or other signs of liver problems.

Seek medical attention promptly for breathing difficulty, severe weakness, confusion, yellowing of the skin or eyes, severe abdominal pain or new neurological symptoms.

• Complete recommended vaccinations before starting Tremfya when possible.

• Do not receive live vaccines while using Tremfya unless specifically advised by your doctor.

• Tell your doctor about any active infection before receiving an injection.

• Inform your doctor if you have had tuberculosis or have been exposed to someone with TB.

• Keep scheduled follow-up appointments, especially if Tremfya is being used for ulcerative colitis or Crohn's disease.

• If you have been prescribed a self-injectable presentation, use only the injection device and technique taught by your healthcare professional.

• Do not freeze or shake the medicine.