Clinical success of Neoral absorption profile

Transplant Proc. 2004 Mar;36(2 Suppl):461S-464S. doi: 10.1016/j.transproceed.2004.01.090.

Abstract

We investigated the clinical benefits of cyclosporine microemulsion preconcentrate (CyA-MEPC; Neoral) in 16 de novo renal transplant recipients. The dose of CyA-MEPC was managed from AUC(0-4h), with serial target values of AUC(0-4h) at 5000-->4000-->3000-->2000 ng. hr/mL. The frequency of acute rejection episodes was 25%. The decreased renal function reached a low value of 12.5%, and creatinine was stable. Therefore, setting the target AUC(0-4h) value in the early phase at 5000 ng.hr/mL is an effective strategy to prevent acute rejection episodes. The single dose of Neoral given immediately after the renal transplant was 6 mg/kg (making a daily dose of 12 mg/kg). Thereafter, the dose-normalized AUC(0-4h) was set at a constant value to 4 weeks posttransplant. At week 4, the single dose was decreased to 4 mg/kg twice daily (a daily dose of 8 mg/kg). From these studies a daily dose of 12 mg/kg is suggested to be the appropriate amount for the first dose immediately after transplant. The renal biopsy performed at 6 months posttransplant showed neither cyclosporine-induced renal impairments, nor findings of chronic rejection, suggesting that 2000 ng.hr/mL is an appropriate target AUC(0-4h) value in the maintenance phase. These results suggest that it is possible to set the target value of C2 monitoring in the maintenance phase to a value slightly lower than that proposed from other studies.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Area Under Curve
  • Cyclosporine / administration & dosage
  • Cyclosporine / blood
  • Cyclosporine / pharmacokinetics*
  • Cyclosporine / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Graft Rejection / epidemiology
  • Graft Rejection / prevention & control
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / therapeutic use
  • Intestinal Absorption / physiology*
  • Kidney Transplantation / immunology*
  • Kidney Transplantation / physiology
  • Male
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / therapeutic use
  • Postoperative Period
  • Time Factors

Substances

  • Immunosuppressive Agents
  • Cyclosporine
  • Mycophenolic Acid