Remibrutinib is a kinase inhibitor indicated for adult patients who remain symptomatic despite use of H1 antihistamine for the treatment of chronic spontaneous urticaria. It is available as tablets for oral use. MedsAcross supplies Remibrutinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
RHAPSIDO ® is indicated for adult patients who remain symptomatic despite use of H1 antihistamine for the treatment of: chronic spontaneous urticaria. symptomatic dermographism. RHAPSIDO ® is a kinase inhibitor indicated for adult patients who remain symptomatic despite use of H1 antihistamine for the treatment of: chronic spontaneous urticaria. symptomatic dermographism.
Source: US FDA prescribing information
Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes. BTK is involved in intracellular signaling via Fc epsilon receptor-1 (FcεR1), Fc gamma receptors (FcγR), and the B cell antigen receptor (BCR). Remibrutinib also inhibits the BTK-related kinases tec protein tyrosine kinase (TEC) and BMX non-receptor tyrosine kinase (BMX). Remibrutinib inhibits mast cell and basophil degranulation, including release of histamine and other proinflammatory mediators, mediated by pathogenic IgE or IgG directed against the FcεR1 or IgE.
Source: US FDA prescribing information
Recommended dosage is 25 mg orally twice daily with or without food. Swallow tablets whole. Do not split, crush, or chew RHAPSIDO. Interrupt RHAPSIDO for 3 to 7 days pre- and post-surgery.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Risk of Bleeding: Monitor for signs and symptoms of bleeding. Interrupt treatment with RHAPSIDO if bleeding is observed or pre- and post-surgery. Concomitant use of antithrombotic agents with RHAPSIDO may further increase risk of bleeding. Live Attenuated Vaccines: Avoid live or live-attenuated vaccines in patients receiving RHAPSIDO.
Source: US FDA prescribing information
The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain.
Source: US FDA prescribing information
Strong or Moderate CYP3A4 Inhibitors: Avoid concomitant use with RHAPSIDO. Strong or Moderate CYP3A4 Inducers: Avoid concomitant use with RHAPSIDO. P-gp Substrates: Exposure increases where minimal concentration changes may lead to serious adverse reactions: Monitor more frequently for adverse reactions when used concomitantly with RHAPSIDO. Antithrombotic Agents: Consider the risks and benefits of concomitant use of antithrombotic agents with RHAPSIDO.
Source: US FDA prescribing information
Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Dispense and store in the original container in order to protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Remibrutinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Rhapsido 25 mg tabletOral | Novartis Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Remibrutinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Remibrutinib, including Rhapsido.
Yes. The US FDA first approved Remibrutinib on 30 September 2025, according to Drugs@FDA.
Yes. Remibrutinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Remibrutinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Remibrutinib is classified under ATC code L04AA60 (Remibrutinib).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.