Skip to main content
Log in

Basiliximab

  • Adis New Drug Profile
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

  • ▴ The chimaeric monoclonal antibody basiliximab specifically binds the a subunit of the interleukin-2 (IL-2) receptor on activated T lymphocytes. Through competitive antagonism of IL-2, basiliximab supplements standard immunosuppressive therapy after renal transplantation.

  • ▴ ≤24 hours after a single intravenous dose of basiliximab 2.5 to 25mg, ≈90% of available IL-2 receptors on T lymphocytes were complexed with the drug. This level of basiliximab binding was maintained for 4 to 6 weeks when renal transplant patients received basiliximab 20mg 2 hours before and then 4 days after transplantation surgery.

  • ▴ In 2 large, well-designed trials, the percentage of patients with biopsy-confirmed acute rejection episodes after renal transplantation was significantly lower with basiliximab 20mg (administered 2 hours before and then 4 days after transplantation surgery; 30 or 33%, respectively) than placebo (44 or 46%) at 6 months after surgery.

  • ▴ Basiliximab was well tolerated during clinical trials. The incidence of infections (including active cytomegalovirus infection) and post-transplant lymphoproliferative disorders was similar with basiliximab and placebo. Cytokine release syndrome was not observed in patients who received basiliximab.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Ferguson R. Acute rejection episodes — best predictor of long-term primary cadaveric renal transplant survival. Clin Transpl 1994; 8: 328–31

    CAS  Google Scholar 

  2. Cole E, Naimark D, Aprile M, et al. An analysis of predictors of long-term cadaveric renal allograft survival. Clin Transpl 1995; 9: 282–8

    CAS  Google Scholar 

  3. Matas AJ, Gillingham KJ, Payne WD, et al. The impact of an acute rejection episode on long-term renal allograft survival (t½). Transplantation 1994; 57(6): 857–9

    Article  PubMed  CAS  Google Scholar 

  4. Perico N, Remuzzi G. Prevention of transplant rejection: current treatment guidelines and future developments. Drugs 1997 Oct; 54(4): 533–70

    Article  PubMed  CAS  Google Scholar 

  5. Wilde MI, Goa KL. Muromonab CD3: a reappraisal of its pharmacology and use as prophylaxis of solid organ transplant rejection. Drugs 1996 May; 51(5): 865–94

    Article  PubMed  CAS  Google Scholar 

  6. Queen C, Schneider WP, Selick HE, et al. A humanized antibody that binds to the interleukin 2 receptor. Proc Natl Acad Sci U S A 1989 Dec; 86: 10029–33

    Article  PubMed  CAS  Google Scholar 

  7. Vincenti F, Kirkman R, Light S, et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998 Jan 15; 338(3): 161–5

    Article  PubMed  CAS  Google Scholar 

  8. Spencer CM, Goa KL, Gillis JC. Tacrolimus: an update of its pharmacology and clinical efficacy in the management of organ transplantation. Drugs 1997 Dec; 54(6): 925–75

    Article  PubMed  CAS  Google Scholar 

  9. Fulton B, Markham A. Mycophenolate mofetil: a review of its pharmacodynamic and pharmacokinetic properties and clinical efficacy in renal transplantation. Drugs 1996 Feb; 51(2): 278–98

    Article  PubMed  CAS  Google Scholar 

  10. Janeway Jr CA, Travers P. Immunobiology: the immune system in health and disease. London: Current Biology Ltd and Garland Publishing Inc, 1994

    Google Scholar 

  11. Amlot PL, Rawlings E, Fernando ON, et al. Prolonged action of a chimeric interleukin-2 receptor (CD25) monoclonal antibody used in cadaveric renal transplantation. Transplantation 1995 Oct 15; 60(7): 748–56

    Article  PubMed  CAS  Google Scholar 

  12. Novartis Pharmaceutical Corporation. Simulect® (basiliximab) monograph. 1998, Novartis Pharmaceutical Corporation (data on file)

  13. Kovarik JM, Rawlings E, Sweny O, et al. Prolonged immunosuppressive effect and minimal immunogenicity from chimeric (CD25) monoclonal antibody SDZ CHI 621 in renal transplantation. Transplant Proc 1996 Apr; 28(2): 913–4

    PubMed  CAS  Google Scholar 

  14. Kovarik J, Wolf P, Cisterne JM, et al. Disposition of basiliximab, an interleukin-2 receptor monoclonal antibody, in recipients of mismatched cadaver renal allografts. Transplantation 1997 Dec 27; 64: 1701–5

    Article  PubMed  CAS  Google Scholar 

  15. Kahan BD, Rajagopalan PR, Hall ML, et al. Basiliximab (Simulect™) is efficacious in reducing the incidence of acute rejection episodes in renal allograft patients: results at 12 months [abstract no. 748]. Transplantation 1998 Jun 27; 65(12): S189

    Article  Google Scholar 

  16. Kovarik J, Mentser M, Broyer P, et al. Disposition of basiliximab, a chimeric IL-2 receptor (CD25) monoclonal antibody, in pediatric renal transplant patients [abstract no. 254]. Transplantation 1998 Jun 27; 65(12): S66

    Article  Google Scholar 

  17. Kovarik JM, Gerbeau C, Legay F, et al. Clinical impact of chimerization on the immunogenicity of T-cell antigen monoclonal antibodies in renal transplantation [abstract no. 253]. Transplantation 1998; 65 Suppl. 1: 142

    Google Scholar 

  18. Nashan B, Moore R, Amlot P, et al. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. Lancet 1997 Oct 25; 350: 1193–8

    Article  PubMed  CAS  Google Scholar 

  19. Nashan B et al. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients (published erratum appears in Lancet 1997 Nov; 350 (9089): 1484) Lancet 1997 Oct 25; 350: (1195)

    Article  Google Scholar 

  20. Kahan BD, Rajagopalan PR, Hall M, et al. Reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody. Transplantation 1998 In press

  21. Mulloy LL, Wright F, Hall ML, et al. Basiliximab (Simulect™) reduces acute cellular rejection in renal allografts from cadaveric and living donors [abstract no. 749]. Transplantation 1998 Jun 27; 65(12): S190

    Article  Google Scholar 

  22. Solez K, Axelson RA, Benediktsson H, et al. International standardization of criteria for the histologie diagnosis of renal allograft rejection: the Banff working classification of kidney transplant pathology. Kidney Int 1993; 44: 411–22

    Article  PubMed  CAS  Google Scholar 

  23. Nashan B, Thistlethwaite R, Schmidt A-G, et al. Reduced acute rejection and superior one-year renal allograft survival with basiliximab (Simulect™) in patients with diabetes mellitus [abstract no. 707]. Transplantation 1998 Jun 27; 65(12):S179

    Article  Google Scholar 

  24. Lorber M, Evans C, Fastenau J, et al. An economic evaluation of basiliximab (Simulect®) for the prevention of acute rejection in renal allograft recipients [abstract]. Transplantation 1998 Jun 27; 65: S55

    Google Scholar 

  25. Nalesnik MA, Makowka L, Starzl TE. The diagnosis and treatment of post-transplant lymphoproliferative disorders. Curr Probl Surg 1988 Jun; 25(6): 367–472

    Article  PubMed  CAS  Google Scholar 

  26. Breidenbach T, Kovarik J, Gerbeau C, et al. Pharmacokinetic and pharmacodynamic evaluations of basiliximab (Simulect™) in a phase I/II trial in liver transplanted patients [abstract]. 3rd International Conference on New Trends in Clinical Immunosuppression; 1998 Feb 12–15; Geneva

  27. Kovarik J, Breidenbach T, Gerbeau C, et al. Disposition and immunodynamics of basiliximab in liver allograft recipients. Clin Pharmacol Ther 1998 Jul; 64: 66–72

    Article  PubMed  CAS  Google Scholar 

  28. Nashan B, Breidenbach T, Korn A, et al. Immunoprophylaxis with a chimeric anti-IL-2R monoclonal antibody in liver transplanted patients [online; abstract]. American Society of Transplant Physicians Meeting, 1997. Available from URL: http://www.astp.org [Accessed 16 Dec 1998]

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Susan V. Onrust.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Onrust, S.V., Wiseman, L.R. Basiliximab. Drugs 57, 207–213 (1999). https://doi.org/10.2165/00003495-199957020-00006

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00003495-199957020-00006

Keywords

Navigation