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MEKTOVI®Highlights (binimetinib)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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: 10/2020

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