Rhapsido (remibrutinib) is filed as Kinase Inhibitor [EPC]. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. ( 1 ) Limitations of Use: Not indicated for other forms of urticaria. ( 1 )
12.1 Mechanism of Action 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.
5 WARNINGS AND PRECAUTIONS 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. (5.1) Live Attenuated Vaccines: Avoid live or live-attenuated vaccines in patients receiving RHAPSIDO. (5.2) 5.1 Risk of Bleeding In placebo-controlled studies in patients with CSU, mucocutaneous-related bleeding occurred in 9% of patients who received RHAPSIDO. Interrupt treatment with RHAPSIDO if bleeding is observed and resume if the benefit is expected to outweigh the risk. Interrupt treatment with RHAPSIDO for 3 to 7 days pre- and post-surgery or invasive procedures. Use of antithrombotic agents concomitantly with RHAPSIDO may further increase the risk of bleeding. Consider the benefits and risks of antithrombotic agents when used concomitantly with RHAPSIDO. Monitor for signs and symptoms of bleeding. 5.2 Live Attenuated Vaccines No data are available on the effects of live or live-attenuated vaccines in patients receiving RHAPSIDO. The use of live and live-attenuated vaccines should be avoided in patients receiving RHAPSIDO.
4 CONTRAINDICATIONS None. None. (4)
Nasopharyngitis (≥3%); Bleeding (≥3%); Headache (≥3%); Nausea (≥3%); Abdominal pain (≥3%)
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain. (6.1)
2 DOSAGE AND ADMINISTRATION Recommended dosage is 25 mg orally twice daily with or without food. (2.1) Swallow tablets whole. Do not split, crush, or chew RHAPSIDO. (2.1) Interrupt RHAPSIDO for 3 to 7 days pre- and post-surgery. (2.2) 2.1 Recommended Dosage The recommended dosage is 25 mg taken orally twice daily with or without food. Swallow RHAPSIDO tablet whole with water. Do not split, crush, or chew RHAPSIDO. Missed Dose(s) If a dose or doses of RHAPSIDO is missed, skip the missed dose, and take the next dose at its regularly scheduled time. Do not take an extra dose(s) of RHAPSIDO to make up for a missed dose(s). 2.2 Temporary Interruption of RHAPSIDO for Surgery Interrupt treatment with RHAPSIDO for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
7 DRUG INTERACTIONS Strong or Moderate CYP3A4 Inhibitors: Avoid concomitant use with RHAPSIDO. (7.1) Strong or Moderate CYP3A4 Inducers: Avoid concomitant use with RHAPSIDO. (7.1) 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. (7.2) Antithrombotic Agents: Consider the risks and benefits of concomitant use of antithrombotic agents with RHAPSIDO. (7.2)
According to its FDA label, Rhapsido (remibrutinib) is approved for: 1 INDICATIONS AND USAGE RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase… For medical advice, please talk to your prescriber or pharmacist.
Rhapsido (remibrutinib) belongs to the Kinase Inhibitor [EPC] class of medications.
The FDA label lists Rhapsido (remibrutinib) as: 3 DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, light yellow, round, curved, unscored, film-coated tablet, debossed with "LV" on one side and Novartis logo on the other side. The tablet diameter is 7 mm. Tablets: 25 mg (3); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Rhapsido. Availability changes as patents expire.
Our ingest of the FDA label for Rhapsido (remibrutinib) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Rhapsido (remibrutinib) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Rhapsido (remibrutinib) as 2025-09-30.
The FDA label lists Novartis Pharmaceuticals Corporation as a labeler/manufacturer of Rhapsido (remibrutinib). Multiple firms may market generics of the same molecule.
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