Use in Special Populations
Key patient populations requiring close monitoring and precautions are as follows:
Pregnant Women
There are currently no clinical research data on the use of brigatinib in pregnant women. If pregnancy occurs during treatment or pregnancy is planned, the patient must inform the doctor of the potential risks the drug may pose to the fetus.
Lactating Women
It is unclear whether the drug is excreted into human milk. For safety reasons, breastfeeding is recommended to be suspended during treatment and for one week after the last dose.
Pediatric Patients
Relevant clinical data are currently lacking to support use in children.
Elderly Patients
Brigatinib should be used under close medical supervision in elderly patients.
Women of Childbearing Potential
Reliable non-hormonal contraceptive measures (e.g., intrauterine device, contraceptive diaphragm) must be used during treatment and for at least four months after drug discontinuation.
Male Partners of Childbearing Potential
As the drug may affect genetic material, male patients must use effective contraceptive measures during treatment and for three months after drug discontinuation.
Drug Interactions with Brigatinib
Special attention is required when brigatinib is used concomitantly with other medications:
Antihypertensive Drugs
Caution and close monitoring are advised when co-administered with antihypertensive drugs that may cause bradycardia.
CYP3A Inhibitors
Strong or moderate CYP3A inhibitors (e.g., certain antibiotics, antifungals) may affect drug metabolism and increase the risk of adverse reactions. Dose adjustment is required for concomitant use.
CYP3A Inducers
Strong or moderate CYP3A inducers (e.g., some antiepileptic drugs) may reduce drug concentrations and impair therapeutic efficacy. Dose adjustment is required for concomitant use.
CYP3A Substrate Drugs
Concomitant use with drugs metabolized by CYP3A (e.g., certain antihypertensives, sedatives) may reduce their efficacy.
Special Note
Patients taking traditional Chinese medicine, health supplements, or chronic medications must provide a complete medication list to their doctor for evaluation before starting brigatinib.
