Info

Brand Name

Zenapax®

Company

Roche Laboratories

Class

• Immunosuppressive humanized monoclonal antibody, specifically binds to and blocks the interleukin-2 receptor alpha chain on the surface of activated T- lymphocytes

Mechanism of Action

• Acts as an IL-2 receptor antagonist by binding with high affinity to the alpha chain of the IL-2 receptor complex and inhibits IL-2 binding

• Competitively inhibits IL-2 mediated activation of lymphocytes

Indications

• Prophylaxis of acute renal allograft rejection when used as part of an immunosuppressive regimen that includes steroids and cyclosporine

Contraindication

• Hypersensitivity to daclizumab or any component of the formulation

Warnings

• Should be administered in facilities equipped and staffed with adequate laboratory and supportive medical resources

• Administration of proteins may cause possible anaphylactoid reactions (none reported)

• Immunosuppressive therapies increase risk for lympho-proliferative disorders and opportunistic infections (incidence in daclizumab-treated patients is similar to placebo)

Special Precautions

• Long-term effect and re-administration after initial course has not been studied

• Pregnancy category C

Adverse Reactions

• Similar to placebo-treated patients

Drug Interactions

• None reported

Formulation

• 5 ml vial containing 25 mg

Dosage

• 1 mg/kg/dose for 5 doses, the first dose within 24 hours of transplantation, then at intervals of 14 days for four doses. Dilute with 50 ml normal saline over 15 minutes.

Editors' Notes:

Daclizumab was approved after a study of 260 cadaver recipients on azathioprine, cyclosporine and prednisone was completed. Daclizumab recipients had a rejection incidence of 22% compared to placebo (35%, p<0.03). New Engl J Med 338(3):161-165, 1998.

Recent data from a kidney pancreas induction study suggests that 2 doses of Daclizumab (2 mg/kg) at day 0 and day 14 is equivalent to 5 doses of 1 mg/kg every 14 days. (Stratta AJ, Alloway RR, Hodge E et al. A multicenter, open-label, comparative trial of two Daclizumab dosing strategies vs. no antibody induction in combination with tacrolimus, mycophenolate mofetil, and steroids for the prevention of acute rejection in simultaneous kidney-pancreas transplant recipients: interim analysis. Clin Transplant ©2002; 16(1):60-8.)

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