Cobimetinib is administered orally with specific dosing regimens and adjustments based on indication and toxicity.
Dosage Regimen and Modifications
Cobimetinib is indicated for BRAF V600E/K-mutant unresectable/metastatic melanoma (combined with vemurafenib) and histiocytic neoplasms (monotherapy). The standard dose is 60 mg once daily for 21 days per 28-day cycle, taken with or without food. For melanoma, BRAF mutation testing is mandatory pre-treatment. Dose reductions (40 mg → 20 mg) or discontinuation are required for adverse events (AEs) such as hemorrhage, cardiomyopathy, or hepatotoxicity. Concurrent CYP3A inhibitors necessitate dose reduction to 20 mg; strong/moderate CYP3A inducers are contraindicated. Missed doses are not replaced. Pediatric use is unapproved due to insufficient efficacy/safety data. Hepatic/renal impairment (excluding severe renal) does not require initial dose adjustment.