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Journal of Transplantation
Volume 2017, Article ID 5646858, 5 pages
https://doi.org/10.1155/2017/5646858
Research Article

Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored

1Department of Nephrology, Hospital del Salvador, Santiago de Chile, Chile
2Faculty of Medicine, Universidad de Chile, Santiago de Chile, Chile
3Faculty of Medicine, Clínica Alemana, Universidad del Desarrollo, Santiago de Chile, Chile

Correspondence should be addressed to Fernando González; lc.cu@flaznogf

Received 3 July 2016; Revised 13 November 2016; Accepted 25 December 2016; Published 26 January 2017

Academic Editor: Raman V. Venkataramanan

Copyright © 2017 Fernando González et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: versus  mg/dL (). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians.