Braftovi

Monitor for new primary malignancies (cutaneous, non-cutaneous). Perform dermatologic exams prior to initiating, every 2 months during, and up to 6 months following treatment discontinuation. Discontinue if RAS-mutation (+) non-cutaneous malignancies develop. Cardiomyopathy (in combination with binimetinib): assess ejection fraction by echocardiogram or MUGA scan prior to initiating, 1 month after, and every 2–3 months during treatment. Cardiovascular risk factors; monitor closely. Baseline ejection fraction <50% or below institutional LLN (in combination with binimetinib): not established. Hepatotoxicity (in combination with binimetinib): monitor LFTs before initiation, monthly during therapy, and as clinically indicated. Uveitis (in combination with binimetinib): assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances. Long QT syndromes, significant bradyarrhythmias, severe or uncontrolled heart failure, concomitant drugs associated with QT prolongation; monitor. Correct hypokalemia and hypomagnesemia prior to and during treatment. Withhold, reduce or permanently discontinue dose if QTc >500ms. Increased risk of certain adverse reactions with Braftovi monotherapy; reduce dose if binimetinib interrupted or discontinued; see full labeling. Moderate to severe hepatic or severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (non-hormonal methods) during and for 2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Monitor for new primary malignancies (cutaneous, non-cutaneous). Perform dermatologic exams prior to initiating, every 2 months during, and up to 6 months following treatment discontinuation. Discontinue if RAS-mutation (+) non-cutaneous malignancies develop. Cardiomyopathy (in combination with binimetinib): assess ejection fraction by echocardiogram or MUGA scan prior to initiating, 1 month after, and every 2–3 months during treatment. Cardiovascular risk factors; monitor closely. Baseline ejection fraction <50% or below institutional LLN (in combination with binimetinib): not established. Hepatotoxicity (in combination with binimetinib): monitor LFTs before initiation, monthly during therapy, and as clinically indicated. Uveitis (in combination with binimetinib): assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances. Long QT syndromes, significant bradyarrhythmias, severe or uncontrolled heart failure, concomitant drugs associated with QT prolongation; monitor. Correct hypokalemia and hypomagnesemia prior to and during treatment. Withhold, reduce or permanently discontinue dose if QTc >500ms. Increased risk of certain adverse reactions with Braftovi monotherapy; reduce dose if binimetinib interrupted or discontinued; see full labeling. Moderate to severe hepatic or severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (non-hormonal methods) during and for 2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Monitor for new primary malignancies (cutaneous, non-cutaneous). Perform dermatologic exams prior to initiating, every 2 months during, and up to 6 months following treatment discontinuation. Discontinue if RAS-mutation (+) non-cutaneous malignancies develop. Cardiomyopathy (in combination with binimetinib): assess ejection fraction by echocardiogram or MUGA scan prior to initiating, 1 month after, and every 2–3 months during treatment. Cardiovascular risk factors; monitor closely. Baseline ejection fraction <50% or below institutional LLN (in combination with binimetinib): not established. Hepatotoxicity (in combination with binimetinib): monitor LFTs before initiation, monthly during therapy, and as clinically indicated. Uveitis (in combination with binimetinib): assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances. Long QT syndromes, significant bradyarrhythmias, severe or uncontrolled heart failure, concomitant drugs associated with QT prolongation; monitor. Correct hypokalemia and hypomagnesemia prior to and during treatment. Withhold, reduce or permanently discontinue dose if QTc >500ms. Increased risk of certain adverse reactions with Braftovi monotherapy; reduce dose if binimetinib interrupted or discontinued; see full labeling. Moderate to severe hepatic or severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (non-hormonal methods) during and for 2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).