Azzure 100mg Injection (Azacitidine)

Azzure 100mg Injection contains azacitidine 100 mg, a hypomethylating agent used for myelodysplastic syndromes (MDS) and selected acute myeloid leukemia (AML) settings. At lower concentrations it inhibits DNA methyltransferases and can restore expression of genes involved in normal maturation; at higher intracellular exposure it also causes direct cytotoxicity. Injectable azacitidine is given subcutaneously or intravenously in repeated 28-day cycles. It is not interchangeable with oral azacitidine 100mg injection products, which have different pharmacokinetics and indications.

Injectable azacitidine 100mg injection is indicated for multiple MDS subtypes and is used in AML, particularly in older/unfit patients and in modern combinations such as azacitidine 100mg injection plus venetoclax under the relevant AML treatment strategy. Disease classification, cytogenetic/molecular risk, transplant eligibility, prior therapy, and blood counts guide treatment. Clinical benefit often requires several cycles, so early cytopenias do not necessarily mean treatment failure.

Azacitidine 100mg injection is incorporated into DNA and RNA. In DNA, it traps DNA methyltransferases and reduces abnormal hypermethylation, while incorporation into RNA and direct cytotoxic effects also contribute to killing abnormal marrow cells.

AZA-001: Azacitidine 100mg injection improved overall survival compared with conventional care regimens in higher-risk MDS.

VIALE-A: Azacitidine 100mg plus venetoclax improved survival and remission outcomes versus azacitidine alone in treatment-naïve AML patients ineligible for intensive chemotherapy

Just like any other medication, the Azzure 100mg Injection is also associated with some side effects. Most of the side effects are minor and usually go away within some time. Here are some of the symptoms, including: 

Common side effects

• Nausea/vomiting
• Injection-site redness/pain
• Fatigue
• Constipation/diarrhea
• Neutropenia
• Thrombocytopenia
• Anemia

Serious side effects

• Severe infection/sepsis
• Severe cytopenias/bleeding
• Renal toxicity
• Tumor lysis syndrome in combination regimens
• Severe hepatic toxicity in susceptible patients

Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.

If a scheduled injection is missed, contact the hematology clinic. Do not add an unscheduled dose. The team will decide how to preserve the cycle while considering blood counts and infection.

• CBC before and during cycles
• Renal/liver function
• Infection/bleeding signs
• Electrolytes/tumour lysis markers in high-risk AML combinations
• Bone-marrow response after adequate treatment exposure​
  

• Current injectable azacitidine 100mg Injection prescribing information (Vidaza/reference). https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050974s034lbl.pdf
• Fenaux P, et al. AZA-001. Lancet Oncology. https://pubmed.ncbi.nlm.nih.gov/19230772/
• DiNardo CD, et al. VIALE-A. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2012971
• Current NCCN/ELN MDS and AML guidelines. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1411​
• Haematologica. Azacitidine 100mg Injection for MDS and CMMl. https://haematologica.org/article/view/13411​