AZACITIDINE TAB
Clinical Criteria Summary
Exclusion Criteria
- Using oral azacitidine as a substitute for parenteral azacitidine (oral and IV formulations are not interchangeable)
- Using oral azacitidine to treat myelodysplastic syndrome (MDS)
- Secondary acute myeloid leukemia (AML) with prior treatment using a hypomethylating agent (i.e., for MDS)
- History of hypersensitivity to azacitidine or mannitol
- Inability to swallow whole tablets
- Baseline absolute neutrophil count < 0.5x10^9/L and platelets < 20x10^9/L
- Renal insufficiency (serum creatinine > 2.5 x upper level of normal [ULN])
- Hepatic insufficiency (total bilirubin > 1.5 x ULN, AST and ALT > 2.5 x ULN)
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care provided by a VA/VA Community Care hematology provider
- Goals of care and role of palliative care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0 to 3
Additional Inclusion Criteria
- Age > 55 with newly diagnosed de novo or secondary AML
- Achievement of complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy
- Not a candidate or unable to complete intensive curative therapy (consolidation therapy, candidate for allogeneic hematopoietic stem cell transplant)