BRAFTOVI® Highlights

(encorafenib)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BRAFTOVI safely and effectively. See full prescribing information for BRAFTOVI.

BRAFTOVI (encorafenib) capsules, for oral use
Initial U.S. Approval: 2018

RECENT MAJOR CHANGES

Indications and Usage (1.3, 1.4)

10/2023

Dosage and Administration (2.1, 2.2, 2.5)

10/2023

Warnings and Precautions (5.1, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8)

10/2023

INDICATIONS AND USAGE

BRAFTOVI is a kinase inhibitor indicated:

•
in combination with binimetinib, 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 cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. (1.2, 2.1)
•
in combination with binimetinib, 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. (1.3, 2.1)

Limitations of Use

BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. (1.4, 5.2)

DOSAGE AND ADMINISTRATION

•
Melanoma
o
Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of BRAFTOVI. (2.1)
o
The recommended dose is 450 mg orally once daily in combination with binimetinib. (2.2)
•
CRC
o
Confirm the presence of BRAF V600E mutation in tumor specimens prior to the initiation of BRAFTOVI. (2.1)
o
The recommended dose is 300 mg orally once daily in combination with cetuximab. (2.3)
•
NSCLC
o
Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating BRAFTOVI. (2.1)
o
The recommended dose is 450 mg orally once daily in combination with binimetinib. (2.2)
•
Take BRAFTOVI with or without food. (2.4)

DOSAGE FORMS AND STRENGTHS

Capsules: 75 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
New Primary Malignancies, cutaneous and non-cutaneous: Can occur. Monitor for malignancies and perform dermatologic evaluations prior to, while on therapy, and following discontinuation of treatment. (5.1)
•
Tumor Promotion in BRAF Wild-Type Tumors: Increased cell proliferation can occur with BRAF inhibitors. (5.2)
•
Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before initiating treatment with BRAFTOVI and binimetinib, and after one month of treatment, then every 2 to 3 months thereafter. The safety of BRAFTOVI in combination with binimetinib has not been established in patients with LVEF below 50%. (5.3)
•
Hepatotoxicity: Monitor liver function tests before and during treatment with BRAFTOVI and binimetinib and as clinically indicated. (5.4)
•
Hemorrhage: Major hemorrhagic events can occur in patients receiving BRAFTOVI and binimetinib. (5.5)
•
Uveitis: Perform ophthalmologic evaluation at regular intervals and for any visual disturbances. (5.6)
•
QT Prolongation: Monitor electrolytes before and during treatment. Correct electrolyte abnormalities and control for cardiac risk factors for QT prolongation. Withhold BRAFTOVI for QTc of 500 ms or greater. (5.7)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective non-hormonal method of contraception. (5.8, 8.1, 8.3)
•
Risks Associated with BRAFTOVI as a Single Agent: If binimetinib is temporarily interrupted or permanently discontinued, reduce the dose of BRAFTOVI as recommended. (5.9)
•
Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with binimetinib or cetuximab. (5.10)

ADVERSE REACTIONS

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

CRC: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with cetuximab, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. (6.1)

NSCLC: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, 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.

DRUG INTERACTIONS

•
Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavoidable, reduce BRAFTOVI dosage. (2.6, 7.1)
•
Strong CYP3A4 inducers: Avoid coadministration. (7.1)
•
Sensitive CYP3A4 substrates: Avoid coadministration with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. (7.2)
•
Transporters: Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI. (7.2, 12.3)

USE IN SPECIFIC POPULATIONS

•
Lactation: Advise not to breastfeed. (8.2)
•
Males of Reproductive Potential: BRAFTOVI may impair fertility. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BRAFTOVI safely and effectively. See full prescribing information for BRAFTOVI.

BRAFTOVI (encorafenib) capsules, for oral use
Initial U.S. Approval: 2018

RECENT MAJOR CHANGES

Indications and Usage (1.3, 1.4)

10/2023

Dosage and Administration (2.1, 2.2, 2.5)

10/2023

Warnings and Precautions (5.1, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8)

10/2023

INDICATIONS AND USAGE

BRAFTOVI is a kinase inhibitor indicated:

•
in combination with binimetinib, 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 cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. (1.2, 2.1)
•
in combination with binimetinib, 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. (1.3, 2.1)

Limitations of Use

BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. (1.4, 5.2)

DOSAGE AND ADMINISTRATION

•
Melanoma
o
Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of BRAFTOVI. (2.1)
o
The recommended dose is 450 mg orally once daily in combination with binimetinib. (2.2)
•
CRC
o
Confirm the presence of BRAF V600E mutation in tumor specimens prior to the initiation of BRAFTOVI. (2.1)
o
The recommended dose is 300 mg orally once daily in combination with cetuximab. (2.3)
•
NSCLC
o
Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating BRAFTOVI. (2.1)
o
The recommended dose is 450 mg orally once daily in combination with binimetinib. (2.2)
•
Take BRAFTOVI with or without food. (2.4)

DOSAGE FORMS AND STRENGTHS

Capsules: 75 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
New Primary Malignancies, cutaneous and non-cutaneous: Can occur. Monitor for malignancies and perform dermatologic evaluations prior to, while on therapy, and following discontinuation of treatment. (5.1)
•
Tumor Promotion in BRAF Wild-Type Tumors: Increased cell proliferation can occur with BRAF inhibitors. (5.2)
•
Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before initiating treatment with BRAFTOVI and binimetinib, and after one month of treatment, then every 2 to 3 months thereafter. The safety of BRAFTOVI in combination with binimetinib has not been established in patients with LVEF below 50%. (5.3)
•
Hepatotoxicity: Monitor liver function tests before and during treatment with BRAFTOVI and binimetinib and as clinically indicated. (5.4)
•
Hemorrhage: Major hemorrhagic events can occur in patients receiving BRAFTOVI and binimetinib. (5.5)
•
Uveitis: Perform ophthalmologic evaluation at regular intervals and for any visual disturbances. (5.6)
•
QT Prolongation: Monitor electrolytes before and during treatment. Correct electrolyte abnormalities and control for cardiac risk factors for QT prolongation. Withhold BRAFTOVI for QTc of 500 ms or greater. (5.7)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective non-hormonal method of contraception. (5.8, 8.1, 8.3)
•
Risks Associated with BRAFTOVI as a Single Agent: If binimetinib is temporarily interrupted or permanently discontinued, reduce the dose of BRAFTOVI as recommended. (5.9)
•
Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with binimetinib or cetuximab. (5.10)

ADVERSE REACTIONS

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

CRC: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with cetuximab, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. (6.1)

NSCLC: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, 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.

DRUG INTERACTIONS

•
Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavoidable, reduce BRAFTOVI dosage. (2.6, 7.1)
•
Strong CYP3A4 inducers: Avoid coadministration. (7.1)
•
Sensitive CYP3A4 substrates: Avoid coadministration with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. (7.2)
•
Transporters: Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI. (7.2, 12.3)

USE IN SPECIFIC POPULATIONS

•
Lactation: Advise not to breastfeed. (8.2)
•
Males of Reproductive Potential: BRAFTOVI may impair fertility. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2023
Medication Guide

Health Professional Information

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