t of the preceding course, provided that both the WBC and the platelet counts are >25% above the nadir and rising. If a >25% increase above the nadir is not seen by day 28, counts should be reassessed every 7 days. If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.
Dosage Adjustment Based on Renal Function and Serum Electrolytes: If unexplained reductions in serum bicarbonate levels to less than 20 mEq/L occur, the dosage should be reduced by 50% on the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment course (see PRECAUTIONS section).
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, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS section).
Preparation of Vidaza
Vidaza is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing Vidaza suspensions. Please refer to Handling and Disposal section.
If reconstituted Vidaza comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.
Vidaza should be reconstituted aseptically with 4 mL sterile water for injection. The diluent should be injected slowly into the vial. The vial should be inverted 2-3 times and gently rotated until a uniform suspension is achieved. The suspension will be cloudy. The resulting suspension will contain azacitidine 25 mg/mL.
Preparation for Immediate Administration: Doses greater than 4 mL should be divided equally into two syringes. 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 Administration: The reconstituted product may be kept in the vial or drawn into a syringe. Doses greater than 4 mL should be divided equally into two syringes. The product must be refrigerated immediately, and may be held under refrigerated conditions (2°C - 8°C, 36°F- 46°F) for up to 8 hours. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.
Administration
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and gently rolling the syringe between the palms for 30 seconds immediately prior to administration.
Vidaza is administered subcutaneously. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites. Rotate sites for each injection (thigh, abdomen, or upper arm). New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard.
Stability
Reconstituted Vidaza may be stored for up to 1 hour at 25°C (77°F) or for up to 8 hours between 2 and 8°C (36 and 46°F). The Vidaza vial is single-use and does not contain any preservatives. Unused portions of each vial should be discarded properly. See Handling an
