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VIDAZA(azacitidine injection)
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use VIDAZA safely and effectively. See full prescribing information for VIDAZA. |
VIDAZA (azacitidine) injection for subcutaneous and intravenous use
Initial U.S. Approval: 2004
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INDICATIONS AND USAGE
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VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: 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). (1)
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DOSAGE AND ADMINISTRATION
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The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is VIDAZA 75 mg/m2 daily for 7 days to be administered by subcutaneous (SC) injection or intravenous (IV) infusion. Premedicate for nausea and vomiting. (2.1)
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Repeat cycles every 4 weeks (2.2). After 2 cycles, may increase dose to 100 mg/m2 if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred (2.2). Patients should be treated for a minimum of 4 to 6 cycles. Complete or partial response may require additional treatment cycles (2.2).
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Continue treatment as long as the patient continues to benefit (2.2
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