Azacitidine (Vidaza)

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: 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.

Diseases for which it is established (work in progress)

• Acute myeloid leukemia
• Chronic myelomonocytic leukemia
• Juvenile myelomonocytic leukemia
• Myelodysplastic syndrome

Patient drug information

• Azacitidine (Vidaza) patient drug information (Chemocare)
• Brief patient counseling information can be found in the package insert
• Azacitidine (Vidaza) patient drug information (UpToDate)

History of changes in FDA indication

• 2004-05-19: 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. (Based on CALGB 9221)
• 2008-08-20: Approval for myelodysplastic syndrome updated to include overall survival benefit from AZA-001 study. (Based on AZA-001)
• 2022-05-20: Approved for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). (Based on AZA-JMML-001)

History of changes in EMA indication

• 2008-12-17: Initial authorization as Vidaza. Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, and acute myeloid leukaemia (AML) with 20-30% blasts. (Based on AZA-001)
• 2015-10-28: Extension of indication to add treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification. (Based on AZA-AML-001)

History of changes in Health Canada indication

• 2009-10-23: Initial notice of compliance

History of changes in PMDA indication

• 2011-01-21: Initial approval for the treatment of myelodysplastic syndrome.
• 2021-03-23: New indication for the treatment of acute myeloid leukemia.

Also known as

• Generic names: 5-azacitidine, 5-azacytidine
• Brand names: Azacitidina, Azacytin, Azadine, Azafect, Azaplast, Citaza, MyAza, Myelotex, Vidaza, Xpreza