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)].
OATP1B1, OATP1B3, or BCRP Substrates
Coadministration of BRAFTOVI with OATP1B1, OATP1B3, or BCRP substrates can result in increased concentrations of the substrates, and may increase toxicity of these agents. When used in combination, monitor patients closely for signs and symptoms of increased exposure and consider adjusting the dose of these substrates [see Clinical Pharmacology (12.3)].
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.