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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 (1.2, 1.3)04/2020
Dosage and Administration (2)04/2020
Warnings and Precautions (5)04/2020

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)

Limitations of Use

BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma or wild-type BRAF CRC. (1.3, 5.2)

DOSAGE AND ADMINISTRATION

  • Melanoma
    • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of BRAFTOVI. (2.1)
    • The recommended dose is 450 mg orally once daily in combination with binimetinib. (2.2)
  • CRC
    • Confirm the presence of BRAF V600E mutation in tumor specimens prior to the initiation of BRAFTOVI. (2.1)
    • The recommended dose is 300 mg orally once daily in combination with cetuximab. (2.3)
  • 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)
  • Hemorrhage: Major hemorrhagic events can occur. (5.3)
  • Uveitis: Perform ophthalmologic evaluation at regular intervals and for any visual disturbances. (5.4)
  • 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. (5.5)
  • 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. (5.6, 8.1, 8.3)

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)


To report SUSPECTED ADVERSE REACTIONS, contact Array BioPharma at 1-844-792-7729 or FDA at 1-800-FDA-1088 or www.fda.gaov/medwatch.

DRUG INTERACTIONS

  • Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavoidable, reduce BRAFTOVI dosage. (2.6, 7.1)
  • Strong or moderate CYP3A4 inducers: Avoid coadministration. (7.1)
  • Sensitive CYP3A4 substrates: Coadministration with BRAFTOVI may increase toxicity or decrease efficacy of these agents. Avoid coadministration of BRAFTOVI with hormonal contraceptives. (7.2)

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: 4/2020

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