AZACITIDINE FOR

Other

Brand names: AZACITIDINE

Intravenous, Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Azacitidine is a pyrimidine nucleoside analog of cytidine. Azacitidine is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to azacitidine.

Indications

refractory anemia with excess blasts (RAEB)

refractory anemia with excess blasts in transformation (RAEB-T)

refractory anemia with excess blasts (RAEB)

refractory anemia with excess blasts in transformation (RAEB-T)

and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection). However

due to Celgene Corporation's marketing exclusivity rights

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risks of Substitution with Other Azacitidine Products : Do not substitute Azacitidine for oral azacitidine ( 2
Hepatotoxicity : Patients with severe preexisting hepatic impairment are at higher risk for toxicity ( 5
Tumor Lysis Syndrome : Azacitidine may cause fatal or serious tumor lysis syndrome, including in patients with MDS
Assess baseline risk and monitor and treat as appropriate ( 5

Known Side Effects

2 documented side effects by frequency

Fever

1-10%

Drug Not Working

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous, Subcutaneous