AzatiRel ™ (Azacitidine for Injection) contains Azacitidine IP, which 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.
Azacitidine is indicated for treatment of patients with the following French-American- British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory
anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. AzatiRel™ (Azacitidine for injection) is available in 100 mg single-use vials packaged in cartons of 1 vial. Each vial of AzatiRel™ contains 100 mg of Azacitidine IP and 100 mg mannitol as a sterile lyophilized powder.