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Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange

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 r...

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Detalles Bibliográficos
Autores principales: Singh, A. K., Narsipur, S. S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3235899/
https://www.ncbi.nlm.nih.gov/pubmed/22174986
http://dx.doi.org/10.1155/2011/480642
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author Singh, A. K.
Narsipur, S. S.
author_facet Singh, A. K.
Narsipur, S. S.
author_sort Singh, A. K.
collection PubMed
description 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 undertaken with close supervision. The best available information to date, however, does not support the frequently held but unsubstantiated belief that generic preparations of immunosuppressive drugs are not as effective as brand names or that conversion from brand to generic is associated with significant danger. This paper attempts to initiate a discussion of these issues.
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spelling pubmed-32358992011-12-15 Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange Singh, A. K. Narsipur, S. S. J Transplant Review Article 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 undertaken with close supervision. The best available information to date, however, does not support the frequently held but unsubstantiated belief that generic preparations of immunosuppressive drugs are not as effective as brand names or that conversion from brand to generic is associated with significant danger. This paper attempts to initiate a discussion of these issues. Hindawi Publishing Corporation 2011 2011-11-17 /pmc/articles/PMC3235899/ /pubmed/22174986 http://dx.doi.org/10.1155/2011/480642 Text en Copyright © 2011 A. K. Singh and S. S. Narsipur. https://creativecommons.org/licenses/by/3.0/ 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.
spellingShingle Review Article
Singh, A. K.
Narsipur, S. S.
Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange
title Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange
title_full Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange
title_fullStr Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange
title_full_unstemmed Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange
title_short Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange
title_sort cyclosporine: a commentary on brand versus generic formulation exchange
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3235899/
https://www.ncbi.nlm.nih.gov/pubmed/22174986
http://dx.doi.org/10.1155/2011/480642
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