Midostaurin

Indications and Usage

Rydapt is FDA approved for the treatment of adult patients with:

• Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.

  Limitations of Use:
  RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.

• Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). 

Side effects needing medical attention

• AML: The most common adverse reactions were a fever in a patient with neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, nose bleed, device-related infection, hyperglycemia (high blood sugar), and upper respiratory tract infection.
• ASM, SM-AHN, or MCL: The most common adverse reactions were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, fever, headache, and difficulty breathing.

Warning: Monitor for symptoms of interstitial lung disease or pneumonitis. Discontinue Rydapt in patients with signs or symptoms of pulmonary toxicity.