Jane S. Ricciuti, RPh, MS


September 20, 2002

In This Article

Immunosuppressant Agents

(Daclizumab) Injection

Manufacturer: Hoffman-La Roche

Drug Approval Classification: Biologics License Application Supplement (Approval Date: 7/29/02)

New Indication: Zenapax is indicated for the prophylaxis of acute organ rejection in adult and pediatric patients receiving renal transplants. It is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Dosing: The recommended dose for Zenapax in adult and pediatric patients is 1 mg/kg. The calculated volume of Zenapax 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. The standard course of therapy is 5 doses. The first dose should be given no more than 24 hours before transplantation. The 4 remaining doses should be given at intervals of 14 days.

Clinical Summary: Zenapax has been studied in patients ranging in age from 11 months to 17 years. In an open-label study of 60 pediatric patients, the combined incidence of biopsy-proven and clinically presumptive acute rejection at 1 year posttransplantation was 17% (10/60). Patient and graft survival at 1 year posttransplantation were 100% and 96.7%, respectively. The incidence of antidaclizumab antibodies (34%) observed in the first 3 months posttransplantation was higher than the incidence previously observed in adult patients (14%).

Adverse Effects: Adverse effects in pediatric patients were similar to the adverse-effect profile of adults.

Zenapax (Daclizumab) Labeling

Zenapax (Daclizumab)


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