Difference between revisions of "Azacitidine (Vidaza)"
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==General information== | ==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.<ref name="insert">[http://www.vidaza.com/pdf/PI_FINAL.pdf Azacitidine (Vidaza) package insert]</ref><ref>[[:File:Azacitidine.pdf | Azacitidine (Vidaza) package insert (locally hosted backup)]]</ref> | 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.<ref name="insert">[http://www.vidaza.com/pdf/PI_FINAL.pdf Azacitidine (Vidaza) package insert]</ref><ref>[[:File:Azacitidine.pdf | Azacitidine (Vidaza) package insert (locally hosted backup)]]</ref> | ||
| − | <br>Route: IV, SC | + | <br>Route: IV, SC |
<br>Extravasation: [[inflammitant]] | <br>Extravasation: [[inflammitant]] | ||
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/vidaza-azacitidine-342263 Medscape], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/vidaza-azacitidine-342263 Medscape], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| − | ==Diseases for which it is | + | ==Diseases for which it is established== |
*[[Acute myeloid leukemia]] | *[[Acute myeloid leukemia]] | ||
*[[Chronic myelomonocytic leukemia]] | *[[Chronic myelomonocytic leukemia]] | ||
| + | *[[Juvenile myelomonocytic leukemia]] | ||
*[[Myelodysplastic syndrome]] | *[[Myelodysplastic syndrome]] | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
* 5/19/2004: Initial approval for treatment of patients with the following [[Myelodysplastic syndrome | 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 | chronic myelomonocytic leukemia]]. | * 5/19/2004: Initial approval for treatment of patients with the following [[Myelodysplastic syndrome | 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 | chronic myelomonocytic leukemia]]. | ||
| − | * 8/20/2008: Approval updated to include overall survival benefit from AZA-001 study. | + | * 8/20/2008: Approval updated to include overall survival benefit from AZA-001 study. ''(Based on AZA-001)'' |
| + | * 5/20/2022: Approved for pediatric patients with newly diagnosed [[Juvenile myelomonocytic leukemia|juvenile myelomonocytic leukemia (JMML)]]. | ||
==Also known as== | ==Also known as== | ||
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[[Category:Acute myeloid leukemia medications]] | [[Category:Acute myeloid leukemia medications]] | ||
[[Category:Chronic myelomonocytic leukemia medications]] | [[Category:Chronic myelomonocytic leukemia medications]] | ||
| + | [[Category:Juvenile myelomonocytic leukemia medications]] | ||
[[Category:Myelodysplastic syndrome medications]] | [[Category:Myelodysplastic syndrome medications]] | ||
[[Category:FDA approved in 2004]] | [[Category:FDA approved in 2004]] | ||
Revision as of 20:29, 20 May 2022
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.[1][2]
Route: IV, SC
Extravasation: inflammitant
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.[1]
Diseases for which it is established
- Acute myeloid leukemia
- Chronic myelomonocytic leukemia
- Juvenile myelomonocytic leukemia
- Myelodysplastic syndrome
Patient drug information
- Azacitidine (Vidaza) patient drug information (Chemocare)[3]
- Brief patient counseling information can be found in the package insert[1]
- Azacitidine (Vidaza) patient drug information (UpToDate)[4]
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. (Based on AZA-001)
- 5/20/2022: Approved for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
Also known as
- Generic names: 5-azacitidine, 5-azacytidine
- Brand names: Azacitidina, Azacytin, Azadine, Azafect, Azaplast, Citaza, MyAza, Myelotex, Vidaza, Xpreza