Azacitidine oral (Onureg)

General information

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: PO

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

• Acute myeloid leukemia
• Myelodysplastic syndrome

Patient Drug Information

• Azacitidine (Onureg) Package Insert

History of changes in FDA indication

• 9/1/2020: Approved for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. (Based on QUAZAR AML-001)

Also known as

• Code name: CC-486
• Brand name: Onureg