Drug Interaction Report

ADDITIONAL CONTRACEPTION RECOMMENDED: Concomitant use with vorasidenib may decrease the plasma concentrations and efficacy of contraceptive hormones. In vitro studies show that vorasidenib is an inducer of CYP450 3A, the isoenzyme primarily responsible for the metabolic clearance of sex hormones. Decreased hormone concentrations can result in contraception failure and/or increase in breakthrough bleeding. Vorasidenib can cause fetal harm when administered to a pregnant woman.

MANAGEMENT: Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable during concomitant therapy with vorasidenib. Since the use of vorasidenib is likely associated with embryo-fetal harm, it is particularly important that patients not become pregnant during treatment. Therefore, hormonal contraceptives should not be used as the sole method of birth control in women of childbearing potential treated with vorasidenib. Women of childbearing potential should use a highly effective, non-hormonal method of contraception during treatment with vorasidenib and for 3 months after the last dose. Male patients with female partners of reproductive potential should use effective contraception during treatment with vorasidenib and for 3 months after the last dose

GENERALLY AVOID: Due to induction of CYP450 1A2, the isoenzyme primarily responsible for the metabolic clearance of vorasidenib, smoking tobacco during treatment with vorasidenib may decrease its plasma concentrations and anti-tumor effect. Clinical and pharmacokinetic data are currently lacking.

MANAGEMENT: Patient should be advised to avoid smoking tobacco during treatment with vorasidenib because it may reduce efficacy of the therapy.