Difference between revisions of "Azacitidine oral (Onureg)"
m |
|||
| Line 14: | Line 14: | ||
==History of changes in FDA indication== | ==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)'' | * 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)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *6/17/2021: Initial authorization as maintenance therapy in adult patients with [[acute myeloid leukemia|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). | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' CC-486 | *'''Code name:''' CC-486 | ||
| Line 32: | Line 33: | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:EMA approved in 2021]] | ||
Revision as of 12:05, 3 January 2023
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
Patient Drug Information
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)
History of changes in EMA indication
- 6/17/2021: 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).
Also known as
- Code name: CC-486
- Brand name: Onureg