Rhapsido®
Remibrutinib is a kinase inhibitor.1
Remibrutinib has the following uses:
Remibrutinib is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.1
Remibrutinib is not indicated for other forms of urticaria.1
Remibrutinib is available in the following dosage form(s) and strength(s):
Tablets: 25 mg1
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
None.1
In placebo-controlled studies in patients with chronic spontaneous urticaria (CSU), mucocutaneous-related bleeding occurred in 9% of patients who received remibrutinib.1 Interrupt treatment with remibrutinib if bleeding is observed and resume if the benefit is expected to outweigh the risk. 1
Interrupt treatment with remibrutinib for 3 to 7 days pre- and post-surgery or invasive procedures.1
Use of antithrombotic agents concomitantly with remibrutinib may further increase the risk of bleeding.1 Consider the benefits and risks of antithrombotic agents when used concomitantly with remibrutinib.1 Monitor for signs and symptoms of bleeding.1
No data are available on the effects of live or live-attenuated vaccines in patients receiving remibrutinib.1 The use of live and live-attenuated vaccines should be avoided in patients receiving remibrutinib.1
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to remibrutinib during pregnancy.1 Pregnant women exposed to remibrutinib and healthcare providers are encouraged to contact Novartis Pharmaceuticals Corporation at 1-888-669-6682. 1
Available data on the use of remibrutinib during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.1
In animal reproduction studies, oral administration of remibrutinib to pregnant rabbits during organogenesis at exposures 141-times the human exposure at the maximum recommended human dose (MRHD) of 25 mg twice daily based on AUC resulted in adverse developmental outcomes including external malformations.1 No adverse developmental effects were observed with oral administration of remibrutinib to pregnant rats during organogenesis at exposures up to 126-times the human exposure at the MRHD.1
The background risk of major birth defects and miscarriage for the indicated population is unknown.1 All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.1 In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1
No data are available regarding the presence of remibrutinib in either human or animal milk, its effects on the breastfed child, or on milk production.1 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for remibrutinib and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.1
The safety and effectiveness of remibrutinib have not been established in pediatric patients.1
Of the total number of patients treated with remibrutinib in clinical studies for CSU, 53 (8.7%) were 65 to 85 years of age, with no patients over 85 years of age.1 There were no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.1
Remibrutinib exposure is increased in patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, and C) relative to patients with normal hepatic function.1 Avoid use of remibrutinib in patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B, and C).1
The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain.1
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton's tyrosine kinase (BTK).1 BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes.1 BTK is involved in intracellular signaling via Fc epsilon receptor-1 (FcεR1), Fc gamma receptors (FcγR), and the B cell antigen receptor (BCR).1 Remibrutinib also inhibits the BTK-related kinases tec protein tyrosine kinase (TEC) and BMX non-receptor tyrosine kinase (BMX).1
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.1
Additional Information
AHFS first Release™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 25 mg | Rhapsido® | Novartis |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions November 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Novartis Pharmaceuticals Corporation. RHAPSIDO® (remibrutinib) ORAL prescribing information. 2025 Sep. [Web]