Drug Interaction Report

MONITOR: Coadministration of vemurafenib with ipilimumab may potentiate the risk of hepatotoxicity. In a dose-finding clinical trial, grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent vemurafenib (960 mg or 720 mg twice a day) and ipilimumab (3 mg/kg).

MANAGEMENT: The safety and effectiveness of vemurafenib in combination with ipilimumab have not been established. Liver transaminases, alkaline phosphatase, and bilirubin should be monitored prior to initiation of vemurafenib treatment and monthly during treatment, or as clinically indicated. Laboratory abnormalities should be managed with dosage reduction, treatment interruption, or treatment discontinuation in accordance with the product labeling.