Azacitidine oral (Onureg)
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.
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Diseases for which it is used
Patient Drug Information
History of changes in FDA indication
- 2020-09-01: 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)
History of changes in EMA indication
- 2021-06-17: Initial authorization as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). (Based on QUAZAR AML-001)
Also known as
- Code name: CC-486
- Brand name: Onureg