Braftovi Disease Interactions

A recommended dose of encorafenib has not been established for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Dose adjustment is not recommended in patients with mild hepatic impairment (Child-Pugh A).

Cardiomyopathy, manifesting as left ventricular dysfunction, has been reported with use of encorafenib in combination with binimetinib. The safety of encorafenib has not been established in patients with baseline ejection fraction below 50% or below the institutional lower limit of normal. Patients with cardiovascular risk factors should be closely monitored during therapy with encorafenib. Assess ejection fraction at baseline, 1 month after initiation, and every 2 to 3 months during therapy. Withhold, reduce dose, or permanently discontinue therapy based on severity of adverse cardiovascular effects.

Encorafenib is associated with dose-dependent QTc interval prolongation in some patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during therapy with encorafenib. Withhold, reduce dose, or permanently discontinue for QTc > 500 ms.

A recommended dose of encorafenib has not been established for patients with severe renal impairment (CrCl < 30 mL/min). Caution and monitoring is advised if used on these patients. No dose adjustment is recommended for patients with mild to moderate renal impairment (CrCl 30 to < 90 mL/min).

Encorafenib, administered in combination with binimetinib, may cause uveitis, including iritis and iridocyclitis. Assess for visual symptoms at each visit and perform ophthalmologic evaluations at regular intervals, or as indicated, for new or worsening visual disturbances.