Pretransplant test-dose pharmacokinetic profiles: cyclosporine microemulsion versus corn oil-based soft gel capsule formulation.

Journal of the American Society of Nephrology : JASN
S C Chueh, B D Kahan

Abstract

The purpose of this study was to compare the accuracy of pretransplant test-dose pharmacokinetic (PK) profiling after administration of the microemulsion (CsA-ME; Neoral) versus the corn oil-based (CsA-GC; Sandimmune) gel capsule formulations of cyclosporin A (CsA) to estimate posttransplant CsA bioavailability and to individualize starting drug doses. The absolute oral bioavailability (F), clearance rate (CL), average blood concentration (C[av]), peak concentration (Cmax), and time to Cmax (tmax) values were calculated from paired intravenous and oral pretransplant PK profiles of renal transplant candidates, using CsA-GC (n = 70) or CsA-ME (n = 70) administration. The initial posttransplant oral CsA dose was estimated by linear extrapolation of the observed pretransplant value to the target concentration. Because higher mean F (P < 0.0001), but not CL, values were observed in end-stage renal disease patients after CsA-ME compared with CsA-GC treatment, the predicted starting doses for each therapy were markedly different (P < 0.01). From posttransplant days 5 to 7, 54% of patients treated with CsA-ME had a mean dose-normalized C(av) (C(av)/dose, D) value within 20% of the target concentration, compared with 42% of patients tre...Continue Reading

Citations

Sep 26, 2001·Current Opinion in Critical Care·B D Kahan, S M Koch
Feb 24, 2015·Journal of Feline Medicine and Surgery·William Whitehouse, Katrina Viviano
May 23, 2000·Journal of the American Society of Nephrology : JASN·Barry D KahanCharles T VAN Buren
Dec 21, 2000·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·M F PaineK E Thummel
May 20, 1999·Transplantation Proceedings·B D Kahan
May 20, 1999·Transplantation Proceedings·J H Helderman

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