Braftovi

— THERAPEUTIC CATEGORIES —
  • Colorectal and other GI cancers
  • Melanoma and other skin cancers

Braftovi Generic Name & Formulations

General Description

Encorafenib 75mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps 75mg—2x60, 2x90

Manufacturer

Generic Availability

NO

Braftovi Indications

Indications

In combination with cetuximab for the treatment of metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Limitations of Use

Not for treatment of wild-type BRAF CRC.

Braftovi Dosage and Administration

Adult

Confirm BRAF V600E mutation prior to initiation. 300mg once daily with cetuximab until disease progression or unacceptable toxicity. Discontinue Braftovi if cetuximab is discontinued. Dose modifications for adverse reactions, concomitant strong or moderate CYP3A4 inhibitors: see full labeling. Also, refer to cetuximab labeling for dosing.

Children

Not established.

Braftovi Contraindications

Not Applicable

Braftovi Boxed Warnings

Not Applicable

Braftovi Warnings/Precautions

Warnings/Precautions

Monitor for new primary malignancies (cutaneous, non-cutaneous). Perform dermatologic exams prior to initiating, every 2 months during, and up to 6 months following treatment discontinuation. Discontinue if RAS-mutation (+) non-cutaneous malignancies develop. Uveitis: assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances. Long QT syndromes, significant bradyarrhythmias, severe or uncontrolled heart failure, concomitant drugs associated with QT prolongation; monitor. Correct hypokalemia and hypomagnesemia prior to and during treatment. Withhold, reduce or permanently discontinue dose if QTc >500ms. Increased risk of certain adverse reactions with Braftovi monotherapy; reduce dose if binimetinib interrupted or discontinued; see full labeling. Moderate to severe hepatic or severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (non-hormonal methods) during and for 2 weeks after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Braftovi Pharmacokinetics

See Literature

Braftovi Interactions

Interactions

Potentiated by strong or moderate CYP3A4 inhibitors (including grapefruit juice); avoid; reduce dose if unavoidable. Antagonized by strong or moderate CYP3A4 inducers; avoid. May affect sensitive CYP3A4 substrates. May antagonize hormonal contraceptives; avoid. May potentiate OATP1B1, OATP1B3, or BCRP substrates; monitor for toxicity and consider adjusting dose of these substrates. Avoid concomitant drugs known to prolong QT/QTc interval.

Braftovi Adverse Reactions

Adverse Reactions

Fatigue, nausea, abdominal pain, arthralgia; hemorrhage (discontinue if Grade 4 reaction reoccurs), potential male infertility. In combination with binimetinib: also vomiting. In combination wtih cetuximab: also diarrhea, dermatitis acneiform, decreased appetite, rash.

Braftovi Clinical Trials

See Literature

Braftovi Note

Not Applicable

Braftovi Patient Counseling

See Literature

Braftovi Generic Name & Formulations

General Description

Encorafenib 75mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps 75mg—2x60, 2x90

Manufacturer

Generic Availability

NO

Braftovi Indications

Indications

In combination with binimetinib for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Limitations of Use

Not for treatment of wild-type BRAF melanoma.

Braftovi Dosage and Administration

Adult

Confirm BRAF V600E or V600K mutation prior to initiation. 450mg once daily with binimetinib until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant strong or moderate CYP3A4 inhibitors: see full labeling. Also, refer to binimetinib labeling for dosing.

Children

Not established.

Braftovi Contraindications

Not Applicable

Braftovi Boxed Warnings

Not Applicable

Braftovi Warnings/Precautions

Warnings/Precautions

Monitor for new primary malignancies (cutaneous, non-cutaneous). Perform dermatologic exams prior to initiating, every 2 months during, and up to 6 months following treatment discontinuation. Discontinue if RAS-mutation (+) non-cutaneous malignancies develop. Uveitis: assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances. Long QT syndromes, significant bradyarrhythmias, severe or uncontrolled heart failure, concomitant drugs associated with QT prolongation; monitor. Correct hypokalemia and hypomagnesemia prior to and during treatment. Withhold, reduce or permanently discontinue dose if QTc >500ms. Increased risk of certain adverse reactions with Braftovi monotherapy; reduce dose if binimetinib interrupted or discontinued; see full labeling. Moderate to severe hepatic or severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (non-hormonal methods) during and for 2 weeks after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Braftovi Pharmacokinetics

See Literature

Braftovi Interactions

Interactions

Potentiated by strong or moderate CYP3A4 inhibitors (including grapefruit juice); avoid; reduce dose if unavoidable. Antagonized by strong or moderate CYP3A4 inducers; avoid. May affect sensitive CYP3A4 substrates. May antagonize hormonal contraceptives; avoid. May potentiate OATP1B1, OATP1B3, or BCRP substrates; monitor for toxicity and consider adjusting dose of these substrates. Avoid concomitant drugs known to prolong QT/QTc interval.

Braftovi Adverse Reactions

Adverse Reactions

Fatigue, nausea, abdominal pain, arthralgia; hemorrhage (discontinue if Grade 4 reaction reoccurs), potential male infertility. In combination with binimetinib: also vomiting. In combination wtih cetuximab: also diarrhea, dermatitis acneiform, decreased appetite, rash.

Braftovi Clinical Trials

See Literature

Braftovi Note

Not Applicable

Braftovi Patient Counseling

See Literature

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