PMID: 8937932Nov 1, 1996Paper

Clinical pharmacokinetics of tacrolimus in rescue therapy after renal transplantation

International Journal of Clinical Pharmacology and Therapeutics
K BuddeH H Neumayer

Abstract

Tacrolimus, a potent new immunosuppressive drug, was introduced for rescue therapy in 25 renal transplant recipients with ongoing rejection (n = 24) or severe cyclosporine toxicity (n = 1). A highly significant (p < 0.001) rise in serum creatinine from 138 +/- 14 (3 months before conversion) to 295 +/- 26 mumol/l preceded conversion to tacrolimus. Tacrolimus rescue therapy started 73 +/- 9 months after transplantation, the follow-up was 8 +/- 1 months. Outcome, pharmacokinetics, and side-effects were analyzed. Patient survival was 100% on tacrolimus therapy. Graft survival was 88% after 3 months, and 70% after 8 months. Serum creatinine remained stable during the observation period (Crea after 8 months: 271 +/- 26 mumol/l). Starting with an initial dose of 9.6 +/- 0.3 mg/day (0.14 +/- 0.01 mg/kg/day) we could reduce tacrolimus dose to 6.0 +/- 0.9 mg/day (0.09 +/- 0.02 mg/kg/day; p < 0.001) after 1 month. Tacrolimus trough levels were adjusted to a therapeutic window of 5-8 ng/ml. We had to perform 3.4 +/- 0.5 dose adjustments per patient mainly within the first month after conversion (70%). A high variability in interindividual tacrolimus dose was noted. Last cyclosporine dose was a good predictor of required tacrolimus dose af...Continue Reading

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