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Azacitidine

NEO PLASTIC DISORDERS

ANTINEOPLASTIC ANTIBIOTICS & OTHER - [ NEO PLASTIC DISORDERS ]

Azacitidine is a cytidine analogue. It readily enters tumor cells, becomes activated by intracellular enzyme, gets incorporated into DNA and thereby blocks its function. It is available for injection as a solution and as a liposomal formulation. (1)

Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (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) (2)

Advanced malignant hepatic tumors Hypersensitivity to azacitidine or mannitol (2)

Nausea, vomiting Anemia Thrombocytopenia Pyrexia Leukopenia Diarrhea Injection site erythema Constipation Neutropenia Ecchymosis Petechiae Rigors Weakness Hypokalemia (2)

Renal impairment: Monitor renal function in the elderly (2)

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is 75 mg/m2 daily for 7 days to be administered by subcutaneous (SC) injection or intravenous (IV) infusion. Repeat cycles every 4 weeks. After 2 cycles, dose may be increased to 100 mg/m2 if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred. Patients should be treated for a minimum of 4 to 6 cycles. Complete or partial response may require additional treatment cycles

1. Chabner BA, Bertino J, Cleary J, Ortiz T, Lane A, Supko JG et al. Cytotoxic Agents. In: Brunton L, Chabner B, Knollmann B eds. Goodman & Gilman’s The Pharmacological basis of Therapeutics. 12th ed. USA: McGraw Hill; 2011: 1677- 1730 2. Vidaza (azacitidine for injection). [Internet] [Cited 2013 Oct 13]. Available from: URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s024lbl.pdf