Rhapsido Remibrutinib Tablets

1. Indications and Usage
Chronic Spontaneous Urticaria (CSU):
Remibrutinib is indicated for the treatment of adult patients with chronic spontaneous urticaria (CSU) who have had an inadequate response to H1-antihistamine treatment.
Limitation of Use:
Remibrutinib is not indicated for the treatment of other types of urticaria.
2. Dosage and Administration
Recommended Dosage:
Standard Dose: 25 mg taken orally twice daily.
Duration: Continue treatment as long as clinical benefit is observed.
Administration Instructions:
Administer orally with or without food.
Swallow tablets whole with water. Do not split, crush, or chew the tablets.
3. Mechanism of Action
Bruton Tyrosine Kinase (BTK) Inhibitor:
Remibrutinib is an oral small-molecule kinase inhibitor that inhibits Bruton tyrosine kinase (BTK).
Physiological Effect:
BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and platelets. Remibrutinib inhibits BTK-mediated signaling pathways (including FcεR1, FcγR, and BCR). This inhibits the degranulation of mast cells and basophils (including the release of histamine and other inflammatory mediators), thereby reducing the allergic and inflammatory response associated with CSU.
4. Safety and Warnings
Infections:
Inhibition of BTK may increase the risk of infections. Monitor patients for signs of infection.
Bleeding:
BTK is involved in platelet activation. Bleeding events (such as bruising and petechiae) may occur. Exercise caution in patients receiving anticoagulants or antiplatelet therapies.
Malignancy:
Mutually exclusive with other BTK inhibitors regarding monitoring for secondary malignancies.
5. Adverse Reactions
Most Common (>3%):
Nasopharyngitis, bleeding events (e.g., bruising), headache, nausea, and abdominal pain.
6. Drug Interactions
CYP2C8 Inhibitors:
Remibrutinib is metabolized by CYP2C8. Co-administration with strong CYP2C8 inhibitors (e.g., gemfibrozil) may increase remibrutinib exposure.
CYP3A Inducers:
Co-administration with strong CYP3A inducers may decrease remibrutinib exposure.
7. Pharmaceutical Information
Chemical Description:
Remibrutinib is a selective, irreversible BTK inhibitor.
Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.