MIDOSTAURIN CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Hypersensitivity to midostaurin or any of the excipients
- Inability to swallow whole capsules
- Pregnancy (known pregnancy or positive pregnancy test)
- Lactating
Inclusion Criteria
- Newly diagnosed FLT3 mutation positive Acute Myeloid Leukemia (AML) and eligible for standard induction and consolidation chemotherapy regimens
- Diagnosis of Aggressive Systemic Mastocytosis (ASM), Indolent Systemic Mastocytosis (ISM), Systemic Mastocytosis with Associated Hematologic Neoplasm (SM-AHN) or Mast Cell Leukemia (MCL)
Additional Inclusion Criteria
- Care for the condition provided by VA or VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
Pregnancy & Contraception Counseling Requirements
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risk vs. benefit of taking midostaurin if they were to become pregnant
- For patients who can become pregnant and patients with partners who can become pregnant: Counsel on effective contraception use during treatment and for 4 months following the last dose