Rx Item-Mektovi 15Mg (2700 Mg) Tablets 1X180 Ea

These highlights do not include all the information needed to use MEKTOVI safely and effectively. See full prescribing information for MEKTOVI. MEKTOVI � (binimetinib) tablets, for oral use Initial U.S. Approval: 2018 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. (1, 2.1) DOSAGE AND ADMINISTRATION Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of MEKTOVI. (2.1) The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. (2.2) For patients with moderate or severe hepatic impairment the recommended dose is 30 mg orally twice daily. (2.4, 8.6) DOSAGE FORMS AND STRENGTHS Tablets: 15 mg. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before initiating treatment, after one month of treatment, then every 2 to 3 months thereafter. The safety of MEKTOVI has not been established in patients with LVEF below 50%. (5.1) Venous Thromboembolism: Deep vein thrombosis and pulmonary embolism can occur. (5.2) Ocular Toxicities: Serous retinopathy, retinal vein occlusion (RVO) and uveitis have occurred. Perform an ophthalmologic evaluation at regular intervals and for any visual disturbances. (5.3) Interstitial Lung Disease (ILD): Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD. (5.4) Hepatotoxicity: Monitor liver function tests before and during treatment and as clinically indicated. (5.5) Rhabdomyolysis: Monitor creatine phosphokinase and creatinine periodically and as clinically indicated. (5.6) Hemorrhage: Major hemorrhagic events can occur. (5.7) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective contraception. (5.8, 8.1, 8.3) ADVERSE REACTIONS Most common adverse reactions (? 25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Array BioPharma at 1-844-792-7729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. (8.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 6/2018

RX ITEM-Mektovi 15Mg (2700 Mg) Tablets 1
Generic Name: BINIMETINIB Description: MEKTOVI, 15MG, (2700 MG), TABLETS, 1X180 EA Alt Item #: 5436688 NDC: 70255-0010-02 UPC: 370255-010025 Contract: Contract Alias: Strength: 15MG Form

Mektovi 15Mg (2700 Mg) Tablets 1X180 Ea
BRAND: MEKTOVI NDC: RX70255-0010-02 ,RX70255001002 UPC: 370255-010025,370255010025 Generic Name: BINIMETINIB Description: MEKTOVI, 15MG, (2700 MG), TABLETS, 1X180 EA Alt Item #: 5436688 NDC:

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