Simulect (Basiliximab) - Summary

SIMULECT SUMMARY

Simulect® (basiliximab) is a chimeric (murine/human) monoclonal antibody (IgG_{1[kgr ]}), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor (alpha)-chain (IL-2R(alpha), also known as CD25 antigen) on the surface of activated T-lymphocytes.

Simulect® is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids.

The efficacy of Simulect® for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

SIMULECT NEWS HIGHLIGHTS

Media Articles Related to Simulect (Basiliximab)

New Laboratory Technique Improves Success In "Highly-Sensitized" Kidney Transplants
Source: Transplants / Organ Donations News From Medical News Today [2008.09.23]

Combo Therapy Makes More Kidney Transplants Possible
Source: MedicineNet rituximab Specialty [2008.07.17]

Drug May Prolong Organ Life In Noncompliant Kidney Transplant Patients
Source: Compliance News From Medical News Today [2008.06.02]

Research Questions Inequality Of Skin Cancer Monitoring For Transplant Patients
Source: Transplants / Organ Donations News From Medical News Today [2008.09.05]

Study Points To One Cause Of Higher Rates Of Transplanted Kidney Rejection In Blacks
Source: Transplants / Organ Donations News From Medical News Today [2008.09.02]

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Published Studies Related to Simulect (Basiliximab)

Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab. [2007.03]

Rabbit antithymocyte globulin versus basiliximab in renal transplantation. [2006.11.09]

A prospective, randomized, multicenter trial of tacrolimus-based therapy with or without basiliximab in pediatric renal transplantation. [2006.07]

A randomized multicenter comparison of basiliximab and muromonab (OKT3) in heart transplantation: SIMCOR study. [2006.06.15]

Two-dose basiliximab compared with two-dose daclizumab in renal transplantation: a clinical study. [2006.05]

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Clinical Trials Related to Simulect (Basiliximab)

Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients [Completed]

Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-Term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids [Active, not recruiting]

Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant [Active, not recruiting]

The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis [Not yet recruiting]

A Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Ciclosporin/Ciclosporin Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients [Recruiting]

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