Melanoma and other skin cancers:
Indications for BRAFTOVI:
In combination with binimetinib, for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Limitations of Use:
Not for treatment of wild-type BRAF melanoma.
Confirm BRAF V600E or V600K mutation prior to initiation. 450mg once daily with binimetinib until disease progression or unacceptable toxicity. Concomitant strong or moderate CYP3A4 inhibitors including grapefruit juice: avoid; if unavoidable, reduce Braftovi dose by ⅓ (if strong inhibitor) or by ½ (if moderate inhibitor). Dose modifications for adverse reactions: see full labeling. Refer to binimetinib labeling for dosing.
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. Uveitis: 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. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Females of reproductive potential should use effective contraception (non-hormonal methods) during and for 2 weeks after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Potentiated by strong or moderate CYP3A4 inhibitors including grapefruit juice; avoid (see Adult). Antagonized by strong or moderate CYP3A4 inducers; avoid. May antagonize hormonal contraceptives; avoid. May affect sensitive CYP3A4 substrates. Avoid concomitant drugs known to prolong QT/QTc interval.
In combination with binimetinib: fatigue, nausea, vomiting, abdominal pain, arthralgia; hemorrhage.
Caps 50mg—60; 75mg—90