Vidaza Azacitidine For Injection 100 Mg

Description

VIDAZA (Azacitidine 100 Mg) 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).Dosage And Administration:First Treatment Cycle The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting. Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose. Dosage Adjustment Based On Serum Electrolytes And Renal Toxicity If unexplained reductions in serum bicarbonate levels to less than 20 mEq/L occur, reduce the dosage by 50% for the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, delay the next cycle until values return to normal or baseline and reduce the dose by 50% for the next course.Warning And Precautions:Use In Geriatric Patients Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, select the dose carefully and monitor renal function. Use In Specific Populations]. Preparation Of VIDAZ VIDAZA is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 The VIDAZA vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly [see HOW SUPPLIED]. Do not save any unused portions for later administration. Instructions For Subcutaneous Administration Reconstitute VIDAZA aseptically with 4 mL sterile water for injection. Inject the diluent slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. The resulting suspension will contain azacitidine 25 mg/mL. Do not filter the suspension after reconstitution. Doing so could remove the active substance. Preparation For Immediate Subcutaneous Administration For doses requiring more than 1 vial, divide the dose equally between the syringes (e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe) and inject into two separate sites. Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. Preparation For Delayed Subcutaneous Administration The reconstituted product may be kept in the vial or drawn into a syringe. For doses requiring more than 1 vial, divide the dose equally between the syringes (e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe) and inject into two separate sites. Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial. The product must be refrigerated immediately. When VIDAZA is reconstituted using water for injection that has not been refrigerated, the reconstituted product may be held under refrigerated conditions (2°C -8°C, 36°F -46°F) for up to 8 hours. When VIDAZA is reconstituted using refrigerated (2°C -8°C, 36°F -46°F) water for injection, the reconstituted product may be stored under refrigerated conditions (2°C -8°C, 36°F -46°F) for up to 22 hours. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.