Generic Name and Formulations:
Binimetinib 15mg; tabs.
Array BioPharma, Inc.
Indications for MEKTOVI:
In combination with encorafenib, for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Confirm BRAF V600E or V600K mutation prior to initiation. 45mg twice daily (approx. 12hrs apart) with encorafenib until disease progression or unacceptable toxicity. Moderate or severe hepatic impairment: 30mg twice daily. Dose modifications for adverse reactions: see full labeling. Refer to encorafenib labeling for dosing. Discontinue if encorafenib is permanently discontinued.
Cardiomyopathy: assess LVEF prior to initiating, 1 month after initiation, and then every 2–3 months during treatment. Patients with baseline LVEF below 50% or LLN: not established. Cardiovascular risk factors; monitor closely. Venous thromboembolism (DVT & PE). Ocular toxicities (serious retinopathy, retinal vein occlusion [RVO], uveitis): assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances (esp. within 24hrs for RVO). Assess new or progressive unexplained pulmonary symptoms or for possible interstitial lung disease. Hepatotoxicity: monitor liver tests before initiation, monthly during treatment, and as clinically indicated. Rhabdomyolysis: monitor CPK and creatinine prior to initiating, periodically during, and as clinically indicated. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for ≥30 days after final dose. Nursing mothers: not recommended (during and for 3 days after final dose).
In combination with encorafenib: fatigue, nausea, diarrhea, vomiting, abdominal pain; hemorrhage.
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