Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).
This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated.
The recommended dose is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks (q8w).
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
The recommended dose is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks. For patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks (q4w) may be considered (see section 5.1).
Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment.
No dose adjustment is required (see section 5.2).
There is limited information in subjects aged ≥65 years and very limited information in subjects aged ≥75 years (see section 5.2).
Tremfya has not been studied in these patient populations. No dose recommendations can be made. For further information on elimination of guselkumab, see section 5.2.
The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not been established. No data are available.
Subcutaneous use. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician determines that this is appropriate. However, the physician should ensure appropriate medical follow-up of patients. Patients should be instructed to inject the full amount of solution according to the ‘Instructions for use’ provided in the carton.
For instructions on preparation of the medicinal product before administration, see section 6.6.
Single intravenous doses of guselkumab up to 987 mg (10 mg/kg) have been administered in healthy volunteers and single subcutaneous doses of guselkumab up to 300 mg have been administered in patients with plaque psoriasis in clinical studies without dose-limiting toxicity. In the event of overdose, the patient must be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment must be administered immediately.
2 years.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
Tremfya 100 mg solution for injection in pre-filled syringe:
1 mL solution in a pre-filled glass syringe with a fixed needle and a needle shield, assembled in an automatic needle guard.
Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.
Tremfya 100 mg solution for injection in pre-filled pen:
1 mL solution in a pre-filled glass syringe assembled in a pre-filled pen with an automatic needle guard.
Tremfya is available in a pack containing one pre-filled pen and in a multipack containing 2 (2 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes before injecting Tremfya. The pre-filled syringe or pre-filled pen should not be shaken.
Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended. The solution should be clear, colourless to light yellow, and may contain a few small white or clear particles. Tremfya should not be used if the solution is cloudy or discoloured, or contains large particles.
Each Tremfya pack is provided with an ‘Instructions for use’ leaflet that fully describes the preparation and administration of the pre-filled syringe or pre-filled pen.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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