cyclosporine a commentary on brand versus generic formulation exchange环孢霉素评论品牌与通用配方交换.pdfVIP

Hindawi Publishing Corporation Journal of Transplantation Volume 2011, Article ID 480642, 6 pages doi:10.1155/2011/480642 Review Article Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange A. K. Singh and S. S. Narsipur Division of Nephrology, Department of Medicine, Upstate Medical University, Syracuse, NY 13210-2342, USA Correspondence should be addressed to S. S. Narsipur, narsipur@ Received 25 August 2011; Accepted 26 September 2011 Academic Editor: Andreas Zuckermann Copyright © 2011 A. K. Singh and S. S. Narsipur. 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. The evidence for conversion from brand name to generic equivalent cyclosporine is conflicting. Cyclosporine is a narrow therapeutic-range drug for which small variations in exposure may have severe clinical consequences for transplant patients. There is currently a lack of comparative outcome data relating to the pharmacokinetics of the reference formulation, Neoral, and generic formulations in transplant recipients. A major common concern is the potential inability to attain similar trough levels, an issue that can be easily corrected by ongoing therapeutic drug monitoring to ensure that the new steady state falls within an intended target range. Prospective clinical studies investigating the efficacy and safety of generic formulations in both de novo and long-term transplant patients are also awaited. Until further evidence is available on the conversion of transplant patients to or between generic formulations of cyclosporine, any transfer to a different cyclosporine formulation should be und