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BRAFTOVI®Drug Interactions (encorafenib)

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on BRAFTOVI

Strong or Moderate CYP3A4 Inhibitors

Coadministration of BRAFTOVI with a strong or moderate CYP3A4 inhibitor increases encorafenib plasma concentrations [see Clinical Pharmacology (12.3)] and may increase encorafenib adverse reactions. Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose [see Dosage and Administration (2.6)].

Strong or Moderate CYP3A4 Inducers

Coadministration of BRAFTOVI with a strong or moderate CYP3A4 inducer may decrease encorafenib plasma concentrations [see Clinical Pharmacology (12.3)] and may decrease encorafenib efficacy. Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inducers.

7.2 Effect of BRAFTOVI on Other Drugs

Sensitive CYP3A4 Substrates

Coadministration of BRAFTOVI with sensitive CYP3A4 substrates may increase adverse reactions or decrease efficacy of these agents.

Coadministration of BRAFTOVI with hormonal contraceptives (CYP3A4 substrates) can result in decreased concentrations and loss of hormonal contraceptive efficacy. Avoid coadministration of BRAFTOVI with hormonal contraceptives [see Use in Specific Populations (8.3)].

7.3 Drugs That Prolong the QT Interval

BRAFTOVI is associated with dose-dependent QTc interval prolongation [see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. Avoid coadministration of BRAFTOVI with drugs known to prolong the QT/QTc interval.

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