Do not use in patients with hypersensitivity to midostaurin or its excipients. Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and
RYDAPT is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA-approved test.
Limitations of Use
RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
WARNINGS AND PRECAUTIONS
Acute Myeloid Leukemia
Please see full Prescribing Information for RYDAPT® (midostaurin) capsules.