Remibrutinib is a BTK inhibitor mainly used for the treatment of autoimmune diseases. Its standard dose is twice daily oral administration, and the medication regimen should be adjusted according to liver and kidney function and pregnancy status in special populations. Adverse reactions should be strictly monitored during clinical use.

1. Standard usage and dosage

(1) Adult patients: The recommended dosage is 100mg twice a day, taken on an empty stomach or after a meal. The whole tablet should be swallowed without breaking open.

(2) Maintenance treatment: After symptom control, it can be adjusted to once a day according to medical advice, and medication should be continued until disease progression or intolerable toxicity occurs.

(3) Omission treatment: If the missed dose time does not exceed 4 hours, it should be taken immediately. If it exceeds 4 hours, the dose should be skipped and double medication should not be taken.

2. Medication for special populations

(1) Liver dysfunction: Patients with Child Pugh B grade should reduce their dosage to once a day, while those with Child Pugh C grade should avoid use. Liver function should be monitored monthly during medication.

(2) Renal insufficiency: Patients with eGFR 30-60ml/min do not need to adjust the dosage, while patients with eGFR<30ml/min or dialysis need to reduce the dosage by 50%.

(3) Elderly patients: For those aged 65 and above, there is no need to adjust the starting dose, but it is necessary to strengthen the monitoring of adverse reactions, especially the risk of bleeding.

3 Reproductive related medications

(1) Pregnancy period: Animals show embryotoxicity, and women of childbearing age need to confirm a negative pregnancy before taking medication. Contraception is required during treatment and for 3 months after discontinuation of medication.

(2) Breastfeeding period: Medication can be secreted into breast milk. Breastfeeding should be stopped during the treatment period, and breastfeeding should be resumed at least 7 days after the last dose.

(3) Male patients with fertility needs should take effective contraceptive measures during treatment and within 4 months after discontinuing medication.

4 Principles of Dose Adjustment

(1) Grade 3 non hematological toxicity: Suspend administration until grade 1 is restored, then reduce dosage by 25% and continue. If the same event recurs, the medication will be permanently discontinued.

(2) Grade 4 hematological toxicity: Suspend administration until recovery, with a 50% reduction for the first occurrence and permanent discontinuation for the second occurrence.

(3) Infection management: In case of opportunistic infections, treatment should be interrupted until the infection is under control. In case of severe infections, permanent discontinuation of medication may be considered.