BINIMETINIB TAB
Clinical Criteria Summary
Indication & Patient Population
- • Unresectable or metastatic melanoma (locally advanced Stage IIIB, IIIC, or IV)
- • BRAF V600E or V600K mutation positive
- • Indicated specifically in combination with encorafenib
Exclusion Criteria / Patient Selection Constraints
- • Untreated CNS lesions
- • Uveal or mucosal melanoma
- • Positive serology for HIV
- • Active Hepatitis B or C infection
- • Leptomeningeal metastases
- • History of bone marrow transplant or solid organ transplant
- • Prior BRAF or MEK inhibitor therapy
- • Clinically significant cardiovascular disease
- • Uncontrolled arterial hypertension
- • Pregnancy
Safety & Monitoring Requirements
- • Assess baseline ejection fraction by echocardiogram or MUGA; no safety data available if baseline EF is below 50% or below the institutional lower limit of normal (LLN)
- • Monitor for cardiomyopathy (asymptomatic or symptomatic decrease in LVEF)
- • Assess for vision changes at each visit due to risks of serous retinopathy, retinal vein occlusion, and uveitis
- • Monitor liver function tests prior to therapy and monthly during treatment due to hepatotoxicity risk
- • Monitor CPK and creatinine prior to initiation and periodically during treatment due to rhabdomyolysis risk
- • Use effective contraception due to embryo-fetal toxicity risk
Administration & Pharmacologic Considerations
- • Dosage form: 15 mg tablet
- • May be taken with or without food; store at room temperature
- • Functions as a BRAF inhibitor plus MEK inhibitor combination for first-line treatment of metastatic melanoma