Braftovi Generic Name & Formulations
Legal Class
Rx
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
Legal Class
Rx
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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