RYDAPT

Midostaurin 25mg, Oral capsule, liquid filled

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not take Midostaurin with grapefruit or grapefruit juice. Taking Midostaurin with grapefruit or grapefruit juice may increase side effects of Midostaurin. If you accidentally take Midostaurin with grapefruit or grapefruit juice, immediately tell your doctor about any unusual effects.

· Notes for Professionals: Instruct patients to avoid grapefruit or grapefruit juice during midostaurin treatment due to the potential for increased midostaurin exposure and subsequent toxicity. Midostaurin is a CYP3A4 substrate and grapefruit is a strong CYP3A4 inhibitor. Coadministration of one strong CYP3A4 inhibitor with a single dose of midostaurin increased the exposure of midostaurin and its active metabolites CGP62221 and CGP52421 by 10.4-fold, 3.5-fold, and 1.2-fold, respectively. Coadministration of another strong CYP3A4 inhibitor with twice daily doses of midostaurin increased Day 28 trough concentrations of midostaurin, CGP62221, and CGP52421 by 2.1-fold, 1.2-fold, and 1.3-fold respectively compared with day 21 trough levels with midostaurin alone.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>