Zebutinib is a novel BTK inhibitor that inhibits BTK activity by covalently binding to cysteine at position 481 of the BTK protein, thereby suppressing tyrosine phosphorylation at position 223.
1、 Usage and dosage
Administer orally before or after meals. The recommended daily total dose is 320mg, with a dosing regimen of 160mg each time (2 80mg capsules), twice daily, until disease progression or intolerable toxicity occurs.
2、 Medication for special populations
1. Medication for pregnant and lactating women
1.1 Pregnancy
When administered to pregnant women, it can cause harm to the fetus. There is no existing data on the use of drugs by pregnant women to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It is recommended that women avoid pregnancy when taking it. If used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be informed of the potential risks to the fetus.
When pregnant women take BRUKINSA, it can cause damage to the embryo fetus. It is recommended that female patients with reproductive potential use effective contraception during treatment with BRUKINSA and use effective contraception for at least one week after the last dose of BRUKINSA. If this medication is used during pregnancy, or if the patient becomes pregnant while taking this medication, the potential danger to the fetus should be notified to the patient.
1.2 Breastfeeding
There is no data available on the presence of zanubrutinib or its metabolites in human milk, their effects on breastfed children, or their impact on milk production. Due to the potential serious adverse reactions of BRUKINSA in breastfed children, it is recommended that lactating women do not breastfeed during treatment with BRUKINSA and for at least two weeks after the last dose.
2. Pediatric medication
The safety and efficacy of pediatric patients have not yet been established.
3. Elderly use
Among the 1550 patients who received monotherapy in the clinical trial of this product, 61% of patients were ≥ 65 years old, and 22% of patients were ≥ 75 years old. The incidence of grade 3 adverse reactions and severe adverse reactions in elderly patients (≥ 65 years old) is higher than that in young patients (<65 years old) (57% and 36%, respectively). In terms of efficacy, no overall difference was observed between elderly and young patients. There is no need to adjust the dosage for elderly patients due to age factors.
It is recommended that men avoid having children when receiving BRUKINSA and wait at least one week after the last dose of BRUKINSA.
