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 witha 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 tumorspecimens prior to the initiation of MEKTOVI. (2.1)
The recommended dose is 45 mg orally twice daily in combinationwith encorafenib. Take MEKTOVI with or without food. (2.2)
For patients with moderate or severe hepatic impairment therecommended 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 every2 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 pulmonaryembolism can occur. (5.2)
Ocular Toxicities: Serous retinopathy, retinal vein occlusion (RVO)and uveitis have occurred. Perform an ophthalmologic eva luation atregular intervals and for any visual disturbances. (5.3)
Interstitial Lung Disease (ILD): Assess new or progressive unexplainedpulmonary symptoms or findings for possible ILD. (5.4)
Hepatotoxicity: Monitor liver function tests before and duringtreatment and as clinically indicated. (5.5)
Rhabdomyolysis: Monitor creatine phosphokinase and creatinineperiodically and as clinically indicated. (5.6)
Hemorrhage: Major hemorrhagic events can occur. (5.7)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females withreproductive potential of potential risk to the fetus and to use effectivecontraception. (5.8, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (≥ 25%) for MEKTOVI, in combinationwith encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominalpain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact ArrayBioPharma at 1-844-792-7729 or FDA at 1-800-FDA-1088 orwww.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: 06/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosage
2.3 Dosage Modifications for Adverse Reactions
2.4 Dosage Modifications for Moderate or Severe Hepatic
Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
5.2 Venous Thromboembolism
5.3 Ocular Toxicities
5.4 Interstitial Lung Disease
5.5 Hepatotoxicity
5.6 Rhabdomyolysis
5.7 Hemorrhage
5.8 Embryo-Fetal Toxicity
5.9 Risks Associated with Combination Treatment
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
