Basiliximab

Brand Name

Simulect®

Company

Novartis

Class

• Immunosuppressive chimeric 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

Contraindications

• Hypersensitivity to basiliximab 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 basiliximab-treated patients is similar to placebo)

Special Precautions

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

• Pregnancy Category B

Adverse Reactions

• Similar to placebo-treated patients

Drug Interactions

• None reported

Formulation

• 20 mg vial of lyophilized powder

Dosage

• 20 mg within 2 hours of transplantation surgery and repeated 4 days after transplantation

• Children 2 to 15 years is 12 mg/m2, to a maximum of 20 mg/dose

Editors' Notes:

Basiliximab was approved after a study of 380 cadaver transplant recipients on cyclosporine and prednisone was completed. Basiliximab recipients had a rejection incidence of 29.8% compared to placebo (44%, p=0.01). Steroid-resistant rejection was also lower. Lancet 350(9086):1193-1998, October 25, 1997.

The clinical experience with Basiliximab had confirmed the results of this study with excellent efficacy and low toxicity.

A recent study of high-risk renal transplants compared Thymoglobulin® induction with Simulect. The overall risk of rejection, delayed graft function and graft loss was statistically less frequent with Thymoglobulin®. (Brennan DC. A prospective, randomized, multi-center study of thymoglobulin compared to simulect for induction of immunosuppression: preliminary results. ©2002 American Transplant Congress.)

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