Remibrutinib-RHAPSIDO instruction manual in Chinese

1. Generic name:Remibrutinib

Product name:RHAPSIDO

2. Indications:

Remibrutinib - RHAPSIDO is indicated for the treatment of adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with an H1 antihistamine.

Limitations of use: Remibrutinib is not indicated for other forms of urticaria.

3. Usage and dosage:

1. Recommended dose: The recommended dose of remibrutinib is 25 mg, taken orally twice a day with or without food. Swallow remibrutinib tablets with water. Do not split, crush, or chew remibrutinib.

2. Missed doses: If you miss one or more doses of remibrutinib, skip the missed dose and take the next dose at its regularly scheduled time. Do not take extra doses of remibrutinib to make up for a missed dose.

3. Temporarily interrupt desiccation for surgery: Interrupt remibrutinib treatment for 3 to 7 days before and after surgery depending on the type of surgery and bleeding risk.

4. Adverse reactions:

In clinical studies of remibrutinib, common adverse reactions may include nasopharyngitis, bleeding, headache, nausea, and abdominal pain.

5. Supply and storage:

Remibrutinib tablets are available in 25 mg x 60 tablets and are stored at 20°C to 25°C (68°F to 77°F); tolerances are allowed between 15°C and 30°C (59°F to 86°F). Divide and store in original containers to protect from moisture.

6. Special groups:

1. Women: The available data on the use of remibrutinib during pregnancy are insufficient to assess the risk of drug-related major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical needs for cleft syndrome, and any potential adverse effects of cleft syndrome or underlying maternal disease on the breastfed child

7. 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 platelets. BTK participates in intracellular signaling through Fcε receptor-1 (FcεR1), Fcγ receptor (FcγR) and 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 the release of histamine and other proinflammatory mediators, mediated by pathogenic IgE or IgG against FcεR1 or IgE.

8. Listing situation:

United States:In September 2025, approved for listing (trade name: RHAPSIDO)

China: Not yet available.

Reference materials:https://www.drugs.com/rhapsido.html