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BRAFTOVI
Melanoma and other skin cancers
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Drug Name:

BRAFTOVI Rx

Generic Name and Formulations:
Encorafenib 50mg, 75mg; caps.

Company:
Array BioPharma, Inc.

Therapeutic Use:

RECENT UPDATES

Monograph added.

Indications for BRAFTOVI:

In combination with binimetinib, for 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.

Adult:

Confirm BRAF V600E or V600K mutation prior to initiation. 450mg once daily with binimetinib until disease progression or unacceptable toxicity. Concomitant strong or moderate CYP3A4 inhibitors including grapefruit juice: avoid; if unavoidable, reduce Braftovi dose by ⅓ (if strong inhibitor) or by ½ (if moderate inhibitor). Dose modifications for adverse reactions: see full labeling. Refer to binimetinib labeling for dosing.

Children:

Not established.

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. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Females of reproductive potential should use effective contraception (non-hormonal methods) during and for 2 weeks after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Potentiated by strong or moderate CYP3A4 inhibitors including grapefruit juice; avoid (see Adult). Antagonized by strong or moderate CYP3A4 inducers; avoid. May antagonize hormonal contraceptives; avoid. May affect sensitive CYP3A4 substrates. Avoid concomitant drugs known to prolong QT/QTc interval.

Adverse Reactions:

In combination with binimetinib: fatigue, nausea, vomiting, abdominal pain, arthralgia; hemorrhage.

Generic Availability:

NO

How Supplied:

Caps 50mg—60; 75mg—90

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