RYDAPT

Midostaurin 25mg, Oral capsule, liquid filled

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not take Grapefruit juice together with Midostaurin without approval from your prescriber. Side effects may get worse if you take Grapefruit juice with Midostaurin. If you take Grapefruit juice with Midostaurin, discuss any new or worsening side effects, such as nausea/vomiting, diarrhea, shortness of breath, cough, fever or chills, sore throat, pain or trouble passing urine, bruising, blood in the urine, pinpoint red spots on the skin, or black/tarry stools, with your health care provider.

· Notes for Professionals: Avoid the concomitant use of midostaurin and grapefruit juice as significantly increased exposure of midostaurin and its active metabolite may occur resulting in increased toxicity. If coadministration cannot be avoided, monitor patients for signs and symptoms of midostaurin toxicity (e.g., gastrointestinal toxicity, hematologic toxicity, bleeding, and infection), particularly during the first week of midostaurin therapy for systemic mastocytosis/mast cell leukemia and the first week of each cycle of midostaurin therapy for acute myeloid leukemia. Midostaurin is a CYP3A4 substrate; grapefruit juice is a strong CYP3A4 inhibitor. The AUC values of midostaurin and its metabolites CGP62221 and CGP52421 increased by 10.4-fold, 3.5-fold, and 1.2-fold, respectively, when midostaurin was administered with another strong CYP3A4 inhibitor in a drug interaction study. The Cmin (trough) levels of midostaurin and its metabolites CGP62221 and CGP52421 on day 28 increased by 2.1-fold, 1.2-fold, and 1.3-fold, respectively, when midostaurin was administered with another strong CYP3A4 inhibitor compared with day 21 Cmin levels with midostaurin alone in another drug interaction study.

<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>