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Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating Binimetinib.
Confirm the presence of a BRAF V600E mutation in tumor or plasma specimens prior to initiating Binimetinib. If no mutation is detected in a plasma specimen, test tumor tissue.
The recommended dosage of Binimetinib is 45 mg orally taken twice daily, approximately 12 hours apart, in combination with encorafenib until disease progression or unacceptable toxicity. Refer to the encorafenib prescribing information for recommended encorafenib dosing information.
Binimetinib may be taken with or without food. Do not take a missed dose of Binimetinib within 6 hours of the next dose of Binimetinib. Do not take an additional dose if vomiting occurs after Binimetinib administration but continue with the next scheduled dose.
If encorafenib is permanently discontinued, discontinue Binimetinib. Dose reductions for adverse reactions associated with Binimetinib are presented in Table 1.
Dosage modifications for adverse reactions associated with Binimetinib are presented in Table 2.
Refer to the encorafenib prescribing information for dose modifications for adverse reactions associated with encorafenib.
For patients with moderate (total bilirubin greater than 1.5 and less than or equal to 3 × ULN and any AST) or severe (total bilirubin levels greater than 3 × ULN and any AST) hepatic impairment, the recommended dosage is 30 mg orally taken twice daily.
from FDA，2024.09
