Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of chronic spontaneous urticaria.
The recommended dose of remibrutinib is 25 mg taken orally twice daily, once in the morning and once in the evening.
If a patient misses one or more doses of remibrutinib, the patient should be instructed to take the next dose at its regularly scheduled time. Extra doses of remibrutinib should not be taken to make up for the missed dose or doses.
Prescribers are advised to periodically reassess the need for continued therapy. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for CSU.
It is recommended to interrupt remibrutinib for 3 to 7 days before surgery and for 3 to 7 days after surgery depending upon the type of surgery and the risk of bleeding (see sections 4.4, 4.5 and 4.8).
No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.2). Limited data are available on the use of remibrutinib in patients older than 65 years.
No dose adjustment is required in patients with renal impairment (see section 5.2).
No dose adjustment is required in patients with mild or moderate hepatic impairment. Remibrutinib is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Rhapsido should not be used in infants and children below 6 years of age because of the unknown potential impact on humoral immunity maturation (e.g. generation of protective immunoglobulins and memory B cells).
The safety and efficacy of remibrutinib in children and adolescents 6 to 18 years of age have not been established. No data are available.
Oral use.
Remibrutinib may be taken with or without food. Patients should be instructed to swallow the tablet whole with water. The tablets should not be split, crushed or chewed to ensure the entire dose is delivered correctly.
There was no evidence of dose-limiting adverse events seen with remibrutinib at doses up to 600 mg per day in the phase I clinical studies. Signs and symptoms of remibrutinib overdose have not been established and there is no specific treatment for remibrutinib overdose.
In the event of an overdose, the patient should be treated symptomatically, and supportive measures should be instituted as required.
2 years.
Store in the original package in order to protect from moisture.
Rhapsido is supplied in PA/alu/PVC/alu (polyamide/aluminium/polyvinylchloride/aluminium) blisters with aluminium foil backing and is available in packs containing 30, 60 or 180 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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