"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
ZENAPAX (daclizumab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplants. It is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.
The efficacy of ZENAPAX (daclizumab) for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.
DOSAGE AND ADMINISTRATION
ZENAPAX (daclizumab) is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. The recommended dose for ZENAPAX (daclizumab) in adult and pediatric patients is 1.0 mg/kg (see PRECAUTIONS: Pediatric Use). The calculated volume of ZENAPAX (daclizumab) should be mixed with 50 mL of sterile 0.9% sodium chloride solution and administered via a peripheral or central vein over a 15-minute period.
Based on the clinical trials, the standard course of ZENAPAX (daclizumab) therapy is five doses. The first dose should be given no more than 24 hours before transplantation. The four remaining doses should be given at intervals of 14 days.
No dosage adjustment is necessary for patients with severe renal impairment. No dosage adjustments based on other identified covariates (age, gender, proteinuria, race) are required for renal allograft patients. No data are available for administration in patients with severe hepatic impairment.
Instructions for Administration
- ZENAPAX (daclizumab) IS NOT FOR DIRECT INJECTION. The calculated volume should be diluted in 50 mL of sterile 0.9% sodium chloride solution before intravenous administration to patients. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.
- Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. If particulate matter is present or the solution colored, do not use.
- Care must be taken to assure sterility of the prepared solution, since the drug product does not contain any antimicrobial preservative or bacteriostatic agents.
- ZENAPAX (daclizumab) is a colorless solution provided as a single-use vial; any unused portion of the drug should be discarded.
- Once the infusion is prepared, it should be administered intravenously within 4 hours. If it must be held longer, it should be refrigerated between 2° to 8°C (36° to 46°F) for up to 24 hours. After 24 hours, the prepared solution should be discarded.
- No incompatibility between ZENAPAX (daclizumab) and polyvinyl chloride or polyethylene bags or infusion sets has been observed. No data are available concerning the incompatibility of ZENAPAX (daclizumab) with other drug substances. Other drug substances should not be added or infused simultaneously through the same intravenous line.
- ZENAPAX (daclizumab) should only be administered by healthcare personnel trained in the administration of the drug who have available adequate laboratory and supportive medical resources.
ZENAPAX (daclizumab) is supplied in single-use glass vials. Each vial contains 25 mg of daclizumab in5 mL of solution (NDC 0004-0501-09). Vials should be stored between the temperatures of 2° to 8° C (36° to 46°F); do not shake or freeze. Protect undiluted solution against direct light. Diluted medication is stable for 24 hours at 4°C or for 4 hours at room temperature.
Roche Pharmaceuticals, Hoffmann - La Roche Inc, 340 Kingsland Street, Nutley, New Jersey 07110-1199. Revised: September 2005 Copyright 1999-2005. FDA Rev date: 9/15/2005
Last reviewed on RxList: 10/28/2008
This monograph has been modified to include the generic and brand name in many instances.
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