Class/mechanism: Pyrimidine nucleoside analog of cytidine, causes hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation.
Route: IV, SC (Note: an orally available formulation, CC-486, is currently under investigation)
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
Patient drug information
- Azacitidine (Vidaza) patient drug information (Chemocare)
- Brief patient counseling information can be found on page 7 of the package insert
- Azacitidine (Vidaza) patient drug information (UpToDate)
History of changes in FDA indication
- 5/19/2004: Initial approval for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
- 8/20/2008: Approval updated to include overall survival benefit from AZA-001 study.
Also known as
- Generic names: 5-azacitidine, 5-azacytidine
- Brand names: Azacitidina, Azacytin, Azadine, Azafect, Azaplast, Citaza, MyAza, Myelotex, Vidaza, Xpreza