Pharmacokinetic variability of sirolimus in Taiwanese renal transplant recipients
Journal
Transplantation Proceedings
Journal Volume
36
Journal Issue
7
Pages
2058-2059
Date Issued
2004
Author(s)
Abstract
To evaluate the pharmacokinetic variability of sirolimus (Rapamycin, SRL) in our renal transplant (RTx) recipients, dose-normalized trough concentration (C(0)) of SRL, and their intrasubject coefficients of variation (%CV) were analyzed. Thirty-eight patients were enrolled in regimens containing SRL. Concomitant immunosuppression included steroids (n = 38), cyclosporine (n = 33), tacrolimus (n = 3), and mycophenolate mofetil (n = 7). The mean dose-normalized C(0) was 2.13 +/- 0.91 ng/mL/mg. The intrasubject %CV of the dose-normalized C(0) ranged from 14% to 88% and averaged 42% in our series. The mean dose-normalized C(0) of SRL in our RTx recipients was much lower than that reported in Phase III trials. The intrasubject variation of dose-normalized C(0), even after administrating SRL for 6 months, could still be quite prominent. Thus, we suggest that, to maintain adequate therapeutic concentrations, periodic (monthly or bimonthly) SRL C(0) measurement is necessary in Taiwanese (Oriental) patients receiving SRL.
SDGs
Type
conference paper