Brand Name
Rhapsido
Generic Name
Remibrutinib
View Brand Information FDA approval date: September 30, 2025
Classification: Kinase Inhibitor
Form: Tablet
What is Rhapsido (Remibrutinib)?
RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria 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 in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: Not indicated for other forms of urticaria.
Approved To Treat
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Brand Information
RHAPSIDO (remibrutinib)
1INDICATIONS AND USAGE
RHAPSIDO® is indicated for adult patients who remain symptomatic despite use of H1 antihistamine for the treatment of:
- chronic spontaneous urticaria.
- symptomatic dermographism.
2DOSAGE 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.
3CONTRAINDICATIONS
None.
4OVERDOSAGE
Consider contacting the poison help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
5DESCRIPTION
RHAPSIDO (remibrutinib) is a kinase inhibitor.
Its empirical formula (remibrutinib) is C
Remibrutinib is white to pale yellow powder, and it is practically insoluble in water.
RHAPSIDO is supplied as film-coated tablets for oral administration, with each film-coated tablet containing 25 mg of remibrutinib. The tablet core inactive ingredients are copovidone, croscarmellose sodium, mannitol, microcrystalline cellulose, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet coating inactive ingredients are polyethylene glycol 4000, polyvinyl alcohol, red iron oxide (E172), talc, titanium dioxide (E171), and yellow iron oxide (E172).
6HOW SUPPLIED/STORAGE AND HANDLING
RHAPSIDO tablets are supplied as described in Table 6:
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) [see USP Controlled Room Temperature]. Dispense and store in the original container in order to protect from moisture.
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
Administration Instructions
Inform patients to take RHAPSIDO with or without food. Advise patients not to split, crush, or chew the tablet and to swallow the tablet whole with water
Risk of Bleeding:
Inform patients that bleeding can occur with the use of RHAPSIDO, and to report any signs and symptoms to their healthcare practitioner. Inform patients that RHAPSIDO should be interrupted for 3 to 7 days for any surgical procedures. Instruct patients to inform their healthcare practitioner if they use RHAPSIDO with antithrombotic agents due to the potential increased risk of bleeding
Live Attenuated Vaccines:
Instruct patients to inform the healthcare practitioner that they are taking RHAPSIDO prior to any potential vaccinations. Advise patients that the vaccines containing live virus (live and live-attenuated) should not be given during treatment with RHAPSIDO
Pregnancy:
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy
Distributed by:
© Novartis
T2026-35
8PRINCIPAL DISPLAY PANEL
NDC 0078-1483-20
Rhapsido
(remibrutinib) tablets
25 mg per tablet
Swallow tablets whole with water.
Do not split, crush, or chew tablets.
Rx only
60 tablets
NOVARTIS
