Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
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.
Guselkumab 200 mg concentrate for solution for infusion should only be used for induction dose.
Either of the following two induction dose regimens are recommended:
or
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). See SmPC for Tremfya 100 mg solution for injection and 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:
or
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). See SmPC for Tremfya 100 mg solution for injection and 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 with ulcerative colitis and Crohn's disease below the age of 18 years have not been established. No data are available.
Tremfya 200 mg concentrate for solution for infusion is for intravenous use only. It should be administered over a period of at least one hour. Each vial is for single use only. For instructions on dilution 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.
Diluted solution for infusion:
The diluted infusion solution may be kept at room temperature up to 25°C for up to 10 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 10 hours after the dilution in the infusion bag.
Do not freeze.
Discard any unused portion of the infusion solution.
Unopened vial:
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
200 mg concentrate solution for infusion in a type I clear glass vial closed with a butyl rubber stopper, an aluminium seal and polypropylene flip top.
Tremfya is available in a 1 vial pack.
Tremfya solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique. Each vial is for single use only.
Inspect Tremfya visually for particulate matter and discolouration prior to administration. Tremfya is a clear and colourless to light yellow solution that may contain small translucent particles. Do not use if the liquid contains large particles, is discoloured or cloudy.
Add Tremfya to a 250 mL intravenous infusion bag of 0.9% Sodium Chloride Injection as follows:
1. Withdraw and then discard 20 mL of the 0.9% Sodium Chloride Injection, from the 250 mL infusion bag which is equal to the volume of Tremfya to be added.
2. Withdraw 20 mL of Tremfya from the vial and add it to the 250 mL intravenous infusion bag of 0.9% Sodium Chloride Injection for a final concentration of 0.8 mg/mL. Gently mix the diluted solution. Discard the vial with any remaining solution.
3. Visually inspect the diluted solution for particulate matter and discolouration before infusion. Infuse the diluted solution over a period of at least one hour.
4. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein binding filter (pore size 0.2 micrometre).
5. Do not infuse Tremfya concomitantly in the same intravenous line with other medicinal products.
6. Dispose any unused medicinal product in accordance with local requirements.
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