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Journal of Transplantation
Volume 2011, Article ID 480642, 6 pages
http://dx.doi.org/10.1155/2011/480642
Review Article

Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange

Division of Nephrology, Department of Medicine, Upstate Medical University, Syracuse, NY 13210-2342, USA

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.

Linked References

  1. H. T. Tribe, “The discovery and development of cyclosporin,” Mycologist, vol. 12, no. 1, pp. 20–22, 1998. View at Google Scholar · View at Scopus
  2. J. M. Kovarik, E. A. Mueller, J. B. van Bree et al., “Cyclosporine pharmacokinetics and variability from a microemulsion formulation—a multicenter investigation in kidney transplant patients,” Transplantation, vol. 58, no. 6, pp. 658–663, 1994. View at Google Scholar · View at Scopus
  3. U. A. Frei, H. -H. Neumayer, B. Buchholz et al., “Randomized, double-blind, one-year study of the safety and tolerability of cyclosporine microemulsion compared with conventional cyclosporine in renal transplant patients,” Transplantation, vol. 65, no. 11, pp. 1455–1460, 1998. View at Publisher · View at Google Scholar
  4. B. D. Kahan, J. Dunn, C. Fitts et al., “Reduced inter- and intrasubject variability in cyclosporine pharmacokinetics in renal transplant recipients treated with a microemulsion formulation in conjunction with fasting, low-fat meals, or high-fat meals,” Transplantation, vol. 59, no. 4, pp. 505–511, 1995. View at Google Scholar · View at Scopus
  5. A. Johnston, P. A. Keown, and D. W. Holt, “Simple bioequivalence criteria: are they relevant to critical dose drugs? Experience gained from cyclosporine,” Therapeutic Drug Monitoring, vol. 19, no. 4, pp. 375–381, 1997. View at Publisher · View at Google Scholar · View at Scopus
  6. E. A. Mueller, J. M. Kovarik, J. B. van Bree, W. Tetzloff, J. Grevel, and K. Kutz, “Improved dose linearity of cyclosporine pharmacokinetics from a microemulsion formulation,” Pharmaceutical Research, vol. 11, no. 2, pp. 301–304, 1994. View at Publisher · View at Google Scholar · View at Scopus
  7. U. Christians, J. Klawitter, and C. F. Clavijo, “Bioequivalence testing of immunosuppressants: concepts and misconceptions,” Kidney International, vol. 77, no. 115, pp. S1–S7, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  8. W. H. Shrank, E. R. Cox, M. A. Fischer, J. Mehta, and N. K. Choudhry, “Patients' perceptions of generic medications,” Health Affairs, vol. 28, no. 2, pp. 546–556, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  9. W. H. Shrank, S. M. Cadarette, E. Cox et al., “Is there a relationship between patient beliefs or communication about generic drugs and medication utilization?” Medical Care, vol. 47, no. 3, pp. 319–325, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  10. “Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations,” Center for Drug Evaluation and Research Web site, 2003, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
  11. J. S. Haas, K. A. Phillips, E. P. Gerstenberger, and A. C. Seger, “Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997–2000,” Annals of internal medicine, vol. 142, no. 11, pp. 891–897, 2005. View at Google Scholar · View at Scopus
  12. J. H. Helderman, N. Kang, A. P. Legorreta, and J. Y. Chen, “Healthcare costs in renal transplant recipients using branded versus generic ciclosporin,” Applied Health Economics and Health Policy, vol. 8, no. 1, pp. 61–68, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  13. D. A. Diarra, M. Riegersperger, M. D. Säemann, and G. Sunder-Plassmann, “Maintenance immunosuppressive therapy and generic cyclosporine A use in adult renal transplantation: a single center analysis,” Kidney International, vol. 77, no. 115, pp. S8–S11, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  14. Š. Vítko and M. Ferkl, “Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial,” Kidney International, vol. 77, no. 115, pp. S12–S16, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  15. D. J. Taber, G. M. Baillie, E. E. Ashcraft et al., “Does bioequivalence between modified cyclosporine formulations translate into equal outcomes?” Transplantation, vol. 80, no. 11, pp. 1633–1635, 2005. View at Publisher · View at Google Scholar · View at Scopus
  16. J. E. Henney, “From the food and drug administration,” Journal of the American Medical Association, vol. 284, no. 10, p. 1234, 2000. View at Google Scholar
  17. A. Johnston, P. Belitsky, U. Frei et al., “Potential clinical implications of substitution of generic cyclosporine formulations for cyclosporine microemulsion (Neoral) in transplant recipients,” European Journal of Clinical Pharmacology, vol. 60, no. 6, pp. 389–395, 2004. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  18. D. Freeman, D. Grant, G. Levy et al., “Pharmacokinetics of a new oral formulation of cyclosporine in liver transplant recipients,” Therapeutic Drug Monitoring, vol. 17, no. 3, pp. 213–216, 1995. View at Google Scholar · View at Scopus
  19. G. F. Cooney, V. Jeevanandam, S. Choudhury, G. Feutren, E. A. Mueller, and H. J. Eisen, “Comparative bioavailability of neoral and sandimmune in cardiac transplant recipients over 1 year,” Transplantation Proceedings, vol. 30, no. 5, pp. 1892–1894, 1998. View at Publisher · View at Google Scholar · View at Scopus
  20. G. F. Cooney, K. Habucky, and K. Hoppu, “Cyclosporin pharmacokinetics in paediatric transplant recipients,” Clinical Pharmacokinetics, vol. 32, no. 6, pp. 481–495, 1997. View at Google Scholar · View at Scopus
  21. S. Dunn, G. Cooney, J. Sommerauer et al., “Pharmacokinetics of an oral solution of the microemulsion formulation of cyclosporine in maintenance pediatric liver transplant recipients,” Transplantation, vol. 63, no. 12, pp. 1762–1767, 1997. View at Publisher · View at Google Scholar · View at Scopus
  22. T. J. Schroeder, S. Hariharan, and M. R. First, “Variations in bioavailability of cyclosporine and relationship to clinical outcome in renal transplant subpopulations,” Transplantation Proceedings, vol. 27, no. 1, pp. 837–839, 1995. View at Google Scholar · View at Scopus
  23. A. Lindholm, M. Welsh, L. Rutzky, and B. D. Kahan, “The adverse impact of high cyclosporine: clearance rates on the incidences of acute rejection and graft loss,” Transplantation, vol. 55, no. 5, pp. 985–993, 1993. View at Google Scholar · View at Scopus
  24. G. F. Cooney, S. B. Fiel, L. M. Shaw, and N. C. Cavarocchi, “Cyclosporine bioavailability in heart-lung transplant candidates with cystic fibrosis,” Transplantation, vol. 49, no. 4, pp. 821–823, 1990. View at Google Scholar · View at Scopus
  25. K. K. C. Tan, K. L. Hue, S. E. Strickland et al., “Altered pharmacokinetics of cyclosporin in heart-lung transplant recipients with cystic fibrosis,” Therapeutic Drug Monitoring, vol. 12, no. 6, pp. 520–524, 1990. View at Google Scholar · View at Scopus
  26. J. M. Kovarik, A. Noe, Y. Wang, I. Mueller, G. DeNucci, and R. L. Schmouder, “Differentiation of innovator versus generic cyclosporine via a drug interaction on sirolimus,” European Journal of Clinical Pharmacology, vol. 62, no. 5, pp. 361–366, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  27. A. Roza, S. Tomlanovich, R. Merion et al., “Conversion of stable renal allograft recipients to a bioequivalent cyclosporine formulation,” Transplantation, vol. 74, no. 7, pp. 1013–1017, 2002. View at Google Scholar · View at Scopus
  28. W. Carnahan and T. Y. Cooper, “Neoral-to-gengraf conversion in renal transplant recipients,” Transplantation Proceedings, vol. 35, no. 4, pp. 1308–1313, 2003. View at Publisher · View at Google Scholar · View at Scopus
  29. Y. A. Qazi, A. Forrest, K. Tornatore, and R. C. Venuto, “The clinical impact of 1:1 conversion from Neoral to a generic cyclosporine (Gengraf) in renal transplant recipients with stable graft function,” Clinical Transplantation, vol. 20, no. 3, pp. 313–317, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  30. A. D. Hibberd, P. R. Trevillian, S. D. Roger et al., “Assessment of the bioequivalence of a generic cyclosporine A by a randomized controlled trial in stable renal recipients,” Transplantation, vol. 81, no. 5, pp. 711–717, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  31. S. Sabatini, R. M. Ferguson, J. Harold Helderman et al., “Drug substitution in transplantation: a National Kidney Foundation white paper,” American Journal of Kidney Diseases, vol. 33, no. 2, pp. 389–397, 1999. View at Google Scholar · View at Scopus
  32. R. R. Alloway, R. Isaacs, K. Lake et al., “Report of the American Society of Transplantation conference on immunosuppressive drugs and the use of generic immunosuppressants,” American Journal of Transplantation, vol. 3, no. 10, pp. 1211–1215, 2003. View at Publisher · View at Google Scholar · View at Scopus