Source: European Medicines Agency (EU) Revision Year: 2025 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).
Tremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.
Tremfya is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
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.
The recommended induction dose is 200 mg administered by intravenous infusion at Week 0, Week 4 and Week 8. See SmPC for Tremfya 200 mg concentrate for solution for infusion.
After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w). Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered (see section 5.1). For the 200 mg dose, see SmPC for Tremfya 200 mg solution for injection.
Immunomodulators and/or corticosteroids may be continued during treatment with guselkumab. In patients who have responded to treatment with guselkumab, corticosteroids may be reduced or discontinued in accordance with standard of care.
Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit after 24 weeks of treatment.
Either of the following two induction dose regimens are recommended:
After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w). Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose regimen of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered (see section 5.1). For the 200 mg dose, see SmPC for Tremfya 200 mg solution for injection.
Immunomodulators and/or corticosteroids may be continued during treatment with guselkumab. In patients who have responded to treatment with guselkumab, corticosteroids may be reduced or discontinued in accordance with standard of care.
Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit after 24 weeks of treatment.
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
No dose adjustment is required (see section 5.2).
There is limited information in patients aged ≥65 years and very limited information in patients aged ≥75 years (see section 5.2).
Tremfya has not been studied in these patient populations. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies, and no dose adjustments are considered necessary. 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 only. Sites for injection include the abdomen, thigh and back of the upper arm. Tremfya should not be injected into areas where the skin is tender, bruised, red, hard, thick or scaly. 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.
Guselkumab intravenous doses up to 1 200 mg as well as subcutaneous doses up to 400 mg at a single dosing visit have been administered 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 bromobutyl rubber stopper, a fixed needle and a needle shield, assembled in an automatic needle guard.
Tremfya is available in packs containing one pre-filled syringe and in multipacks 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 with a bromobutyl rubber stopper, 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 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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