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Concurrent administration of cobimetinib with itraconazole (a strong CYP3A4 inhibitor) increased the systemic exposure of cobimetinib by 6.7-fold. Avoid concurrent use of cobimetinib with strong or moderate CYP3A inhibitors.
If concurrent use of a moderate CYP3A inhibitor (including certain antibiotics such as erythromycin and ciprofloxacin) for a short period (14 days or less) is unavoidable in patients taking 60 mg of cobimetinib, reduce the cobimetinib dose to 20 mg. After discontinuing the moderate CYP3A inhibitor, resume the previous cobimetinib dose.
For patients taking a reduced dose of cobimetinib (40 mg or 20 mg daily), use alternative medications to strong or moderate CYP3A inhibitors.
Concurrent administration of cobimetinib with a strong CYP3A inducer may reduce the systemic exposure of cobimetinib by more than 80% and decrease its efficacy. Avoid concurrent use of cobimetinib with strong or moderate CYP3A inducers, including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John’s wort.
FDA，2023.05
