Remibrutinib is an oral, highly selective, covalently bound inhibitor of Bruton tyrosine kinase (BTK).

1、 Drug name

1. Common name: Remibrutinib

2. Product Name: RHAPSIDO ®

2、 Indications

1. Used to treat adult patients with chronic spontaneous urticaria (CSU) who still have symptoms after treatment with H1 antihistamines.

2. Limitation: Not applicable to other types of urticaria.

3、 Specifications and characteristics

1. Specification: Each tablet contains 25mg of Rabotinib.

2. Appearance: A light yellow, circular, curved, and scratch free thin film garment with "LV" engraved on one side and Novartis logo on the other side, with a diameter of 7mm.

4、 Main components

Active ingredient: Rebutinib.

5、 Usage and dosage

1. Recommended dosage: 25mg orally, twice daily, can be taken with food or on an empty stomach.

2. Usage: Swallow the whole tablet, do not break, crush or chew.

6、 Dose adjustment

1. Omission treatment: Skip the missed dose and take the next dose according to the original plan. Do not make up for it.

2. Before and after surgery: Depending on the type of surgery and bleeding risk, medication should be discontinued for 3 to 7 days before and after surgery.

3. Patients with liver injury: Avoid use for patients with mild, moderate, or severe liver injury (Child Pugh A, B, C grades).

4. Drug interaction adjustment:

Avoid combination with potent or moderate CYP3A4 inhibitors (such as ritonavir, erythromycin) or inducers (such as carbamazepine, efavirenz).

When using P-gp substrates (such as digoxin) in combination, it is necessary to strengthen adverse reaction monitoring.

Combination use of antithrombotic drugs may increase the risk of bleeding, and the pros and cons need to be weighed.

7、 Medication precautions

1. Before/after meals: can be taken with food or on an empty stomach without significant effects.

2. Missed dose: Skip the missed dose and take the next dose according to the original plan.

3. Vomiting: Not specified, it is recommended to consult a physician.

4. Other precautions:

Avoid receiving live or attenuated vaccines during medication.

Monitoring of bleeding signs (such as bruising, nosebleeds, hematuria, black stools, etc.) is necessary, and medication should be discontinued if bleeding occurs.

Medication should be suspended according to medical advice before and after surgery.

8、 Medication for special populations

1. Pregnant women: There is insufficient data available, and animal experiments have shown that high doses may cause fetal malformations.

2. Breastfeeding period: Without data on the presence of Rabotinib in breast milk, it is necessary to balance the benefits of breastfeeding with the necessity of medication.

3. Children: Safety and efficacy have not been established.

4. Elderly: There is no significant difference in safety and efficacy between patients over 65 years old and young adults.

5. Patients with liver injury: Avoid use for patients with all degrees of liver injury.

6. Kidney injury patients: Mild, moderate, and severe kidney injury patients do not require dose adjustment.

9、 Adverse reactions

1. The most common adverse reactions (incidence>3%) include:

Nasopharyngitis (nasal congestion, sore throat, runny nose), bleeding (bruising, nosebleeds, hematuria, etc.), headache, nausea, abdominal pain.

10、 Contraindications

There are no clear contraindications.

11、 Drug interactions

1. Avoid combination use: Strong/moderate CYP3A4 inhibitors or inducers.

2. Caution should be exercised when using:

P-gp substrates (such as digoxin): may increase the risk of adverse reactions and require strengthened monitoring.

Antithrombotic drugs (such as aspirin, clopidogrel): may increase the risk of bleeding.

Drugs with no significant interaction: oral midazolam, oral contraceptives containing ethinylestradiol/levonorgestrel, tolbutamide, caffeine, etc.

12、 Storage method

1. Storage temperature: 20 ° C-25 ° C (68 ° F-77 ° F), short-term storage at 15 ° C-30 ° C (59 ° F-86 ° F) is allowed.

2. Keep the original packaging and prevent moisture.

13、 Manufacturer

Novartis Pharmaceuticals.

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