Pharmacokinetic Variability of Sirolimus in Taiwanese Renal Transplant Recipients
Resource
TRANSPLANTATION PROCEEDINGS v.36 n.7 pp.2058-2059
Journal
TRANSPLANTATION PROCEEDINGS
Journal Volume
v.36
Journal Issue
n.7
Pages
2058-2059
Date Issued
2004
Date
2004
Author(s)
CHUEH, SHIH-CHIEH
WANG, SO-MONG
LAI, MING-KUEN
CHEN, JUN
Abstract
To evaluate the pharmacokinetic variability of sirolimus ( Rapamycin, SRL ) in our renal transplant (RTx) recipients, dose-normalized trough concentration (C0) 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 cyclosporine (n mofetil (n ng/mL/mg. The intrasubject %CV of the dose- normalized C0 ranged from 14% to 88% and averaged 42% in our series. The mean dose-normalized C0 of SRL in our RTx recipients was much lower than that reported in Phase III trials. The intrasubject variation of dose- normalized C0 , 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 C0 measurement is necessary in Taiwanese ( Oriental) patients receiving SRL.