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

RECENT MAJOR CHANGES

Indications and Usage (1.1, 1.2)

10/2023

Dosage and Administration (2.1)

10/2023

Warnings and Precautions (5.1, 5.2)

10/2023

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. (1.1, 2.1)
•
in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. (1.2, 2.1)

DOSAGE AND ADMINISTRATION

Melanoma

•
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)

NSCLC

•
Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI. (2.1)
•
The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. (2.2)

DOSAGE FORMS AND STRENGTHS

Tablets: 15 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
New Primary Malignancies, Cutaneous and Non-cutaneous: Can occur when MEKTOVI is used in combination with encorafenib. Monitor patients for new malignancies prior to initiation of treatment, during treatment, and after discontinuation of treatment. (5.1)
•
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%. (5.2)
•
Venous Thromboembolism: Deep vein thrombosis and pulmonary embolism can occur. (5.3)
•
Ocular Toxicities: Serous retinopathy, retinal vein occlusion (RVO) and uveitis have occurred. Perform an ophthalmologic evaluation at regular intervals and for any visual disturbances. (5.4)
•
Interstitial Lung Disease (ILD): Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD. (5.5)
•
Hepatotoxicity: Monitor liver function tests before and during treatment with MEKTOVI and encorafenib and as clinically indicated. (5.6)
•
Rhabdomyolysis: Monitor creatine phosphokinase and creatinine periodically and as clinically indicated. (5.7)
•
Hemorrhage: Major hemorrhagic events can occur in patients receiving MEKTOVI and encorafenib. (5.8)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective contraception. (5.9, 8.1, 8.3)

ADVERSE REACTIONS

Melanoma: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain. (6.1)

NSCLC: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough. (6.1)

 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 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 Medication Guide.

Revised: 9/2024

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Highlights

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

RECENT MAJOR CHANGES

Indications and Usage (1.1, 1.2)

10/2023

Dosage and Administration (2.1)

10/2023

Warnings and Precautions (5.1, 5.2)

10/2023

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. (1.1, 2.1)
•
in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. (1.2, 2.1)

DOSAGE AND ADMINISTRATION

Melanoma

•
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)

NSCLC

•
Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI. (2.1)
•
The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. (2.2)

DOSAGE FORMS AND STRENGTHS

Tablets: 15 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
New Primary Malignancies, Cutaneous and Non-cutaneous: Can occur when MEKTOVI is used in combination with encorafenib. Monitor patients for new malignancies prior to initiation of treatment, during treatment, and after discontinuation of treatment. (5.1)
•
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%. (5.2)
•
Venous Thromboembolism: Deep vein thrombosis and pulmonary embolism can occur. (5.3)
•
Ocular Toxicities: Serous retinopathy, retinal vein occlusion (RVO) and uveitis have occurred. Perform an ophthalmologic evaluation at regular intervals and for any visual disturbances. (5.4)
•
Interstitial Lung Disease (ILD): Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD. (5.5)
•
Hepatotoxicity: Monitor liver function tests before and during treatment with MEKTOVI and encorafenib and as clinically indicated. (5.6)
•
Rhabdomyolysis: Monitor creatine phosphokinase and creatinine periodically and as clinically indicated. (5.7)
•
Hemorrhage: Major hemorrhagic events can occur in patients receiving MEKTOVI and encorafenib. (5.8)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective contraception. (5.9, 8.1, 8.3)

ADVERSE REACTIONS

Melanoma: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain. (6.1)

NSCLC: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough. (6.1)

 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 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 Medication Guide.

Revised: 9/2024
Medication Guide

Health Professional Information

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