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A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients

Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken t...

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Detalles Bibliográficos
Autores principales: Alloway, R R, Sadaka, B, Trofe-Clark, J, Wiland, A, Bloom, R D
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Inc 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3472020/
https://www.ncbi.nlm.nih.gov/pubmed/22759200
http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x
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author Alloway, R R
Sadaka, B
Trofe-Clark, J
Wiland, A
Bloom, R D
author_facet Alloway, R R
Sadaka, B
Trofe-Clark, J
Wiland, A
Bloom, R D
author_sort Alloway, R R
collection PubMed
description Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken to compare twice-daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC(0–12h) and peak concentration (C(max)) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97–108%, p = 0.486) for AUC(0–12h) and 1.09 (90% CI 101–118%, p = 0.057) for C(max). Mean (SD) C(0) was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines.
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spelling pubmed-34720202012-10-18 A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients Alloway, R R Sadaka, B Trofe-Clark, J Wiland, A Bloom, R D Am J Transplant Brief Communications Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken to compare twice-daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC(0–12h) and peak concentration (C(max)) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97–108%, p = 0.486) for AUC(0–12h) and 1.09 (90% CI 101–118%, p = 0.057) for C(max). Mean (SD) C(0) was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines. Blackwell Publishing Inc 2012-10 /pmc/articles/PMC3472020/ /pubmed/22759200 http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x Text en © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
spellingShingle Brief Communications
Alloway, R R
Sadaka, B
Trofe-Clark, J
Wiland, A
Bloom, R D
A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
title A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
title_full A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
title_fullStr A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
title_full_unstemmed A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
title_short A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
title_sort randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients
topic Brief Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3472020/
https://www.ncbi.nlm.nih.gov/pubmed/22759200
http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x
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