RHAPSIDO Film-coated tablet Ref.[116081] Active ingredients: Remibrutinib

Source: FDA, National Drug Code (US)  Revision Year: 2025 

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.

2. Dosage and Administration

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 [see Warnings and Precautions (5.1), Adverse Reactions (6.1) and Drug Interactions (7.2)].

10. Overdosage

Consider contacting the poison help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

16.2. Storage and Handling

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.

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