The Journal of Heart and Lung Transplantation
Volume 28, Issue 7 , Pages 655-660 , July 2009

Generic Drug Immunosuppression in Thoracic Transplantation: An ISHLT Educational Advisory

  • Patricia A. Uber, PharmD

      Affiliations

    • Division of Cardiology, University of Maryland School of Medicine, Baltimore, Maryland
  • ,
  • Heather J. Ross, MD

      Affiliations

    • Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, Ontario, Canada
  • ,
  • Andreas O. Zuckermann, MD

      Affiliations

    • Department of Cardiothoracic Surgery, Medical University of Vienna, Währinger Gürtel, Vienna, Austria
  • ,
  • Stuart C. Sweet, MD

      Affiliations

    • Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri
  • ,
  • Paul A. Corris, MD

      Affiliations

    • Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne, UK
  • ,
  • Keith McNeil, MD

      Affiliations

    • Queensland Centre for Thoracic Transplantation, The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia
  • ,
  • Mandeep R. Mehra, MBBS

      Affiliations

    • Division of Cardiology, University of Maryland School of Medicine, Baltimore, Maryland
    • Corresponding Author InformationReprint requests: Mandeep R. Mehra, MBBS, Department of Cardiology, University of Maryland Medical Center, 22 South Greene Street, S3B06, Baltimore, MD 21030. Telephone: 410-328-7716. Fax: 410-328-4382

Received 1 May 2009 ,Revised 1 May 2009 ,Accepted 1 May 2009.

References 

  1. Stumpf WE. The dose makes the medicine. Drug Discovery Today. 2006;11:550–555
  2. Health Canada. Guidance for industry (Bioequivalence requirements: critical dose drugs (2006)). http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/critical_dose_critique-eng.php
  3. Verbeeck RK, Kanfer I, Walker RB. Generic substitution: the use of medicinal products containing different salts and implications for safety. Eur J Pharm Sci. 2006;28:1–6
  4. Canada Food and Drug Regulations. Part C Drugs, Division I General, C.01.001 ((1) Definition of serious adverse reaction). http://laws.justice.gc.ca/en/showdoc/cr/C.R.C.-c.870/bo-ga:l_C-gb:s_C_01_001//en#anchorbo-ga:l_C-gb:s_C_01_001
  5. Meyer MC. United States Food and Drug Administration requirements for approval of generic drug products. J Clin Psychiatry. 2001;62(suppl 5):4–9
  6. Birkett DJ. Generics—equal or not? Austral Prescriber 3003;26:85–7.
  7. Federal Regulations 21 CFR 320. Washington, DC: DHHS; 1998;
  8. Palylyk-Colwell E, Jamali F, Dryden W, et al. Bioequivalence and interchangeability of narrow therapeutic range drugs. J Pharm Pharmaceut Sci. 1998;1:2–7
  9. Guidelines for bioequivalence studies for generic products [in Japanese]; 2006. www.nihs.go.jp/drug/be-guide/GL061124_BE.pdf
  10. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Washington, DC: FDA; 2000;http://www.fda.gov/cder/guidance/3618fnl.pdf
  11. Deierhoi MH, Haug M. Review of select transplant subpopulations at high risk of failure from standard immunosuppressive therapy. Clin Transplant. 2000;14:439–448
  12. Schroeder TJ, Hariharan S, First MR. Variations in bioavailability of cyclosporine and relationship to clinical outcome in renal transplant subpopulations. Transplant Proc. 1995;27:837–839
  13. Knoop C, Vervier I, Thiry P, et al. Cyclosporine pharmacokinetics and dose monitoring after lung transplantation: comparison between cystic fibrosis and other conditions. Transplantation. 2003;76:683–688
  14. Reams BD, Palmer SM. Sublingual tacrolimus for immunosuppression in lung transplantation: a potentially important therapeutic option in cystic fibrosis. J Respir Med. 2002;1:91–98
  15. Eadala P, Waud JP, Matthews SB, et al. Quantifying the ‘hidden’ lactose in drugs used for the treatment of gastro-intestinal conditions. Aliment Pharmacol Ther. 2009;29:677–687
  16. Girnita DM, Webber SA, Ferrell R, et al. Disparate distribution of 16 candidate single nucleotide polymorphisms among racial and ethnic groups of pediatric heart transplant patients. Transplantation. 2006;82:1774–1780
  17. Girnita DM, Brooks MM, Webber SA, et al. Genetic polymorphisms impact the risk of acute rejection in pediatric heart transplantation: a multi-institutional study. Transplantation. 2008;85:1632–1639
  18. Miao LY, Huang CR, Hou JQ, et al. Association study of ABCB1 and CYP3A5 gene polymorphisms with sirolimus trough concentration and dose requirements in Chinese renal transplant recipients. Biopharm Drug Dispos. 2008;29:1–5
  19. Macphee IA, Fredericks S, Mohamed M, et al. Tacrolimus pharmacogenetics: the CYP3A5*1 allele predicts low dose-normalized tacrolimus blood concentrations in whites and South Asians. Transplantation. 2005;79:499–502
  20. Department of Health and Human Services, Food and Drug Administration to SangStat Medical Corp; withdrawal of approval on an abbreviated new drug application; cyclosporine. Federal Register. 2000;65:75717
  21. First MR, Alloway R, Schroeder TJ. Development of Sang-35: a cyclosporine formulation bioequivalent to Neoral. Clin Transplant. 1998;12:518–524
  22. Kovarik JM, Barilla D, McMahon L, et al. Administration diluents differentiate Neoral from a generic cyclosporine oral solution. Clin Transplant. 2002;16:306–309
  23. Kovarik JM, Noe A, Wang Y, et al. Differentiation of innovator versus generic via a drug interaction on sirolimus. Eur J Clin Pharmacol. 2006;62:361–366
  24. Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology—drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157–1167
  25. Banahan BF, Kolassa EM. A physician survey on generic drugs and substitution of critical dose medications. Arch Intern Med. 1997;157:2080–2088

 Presented in part at the 29th annual scientific meeting of the ISHLT, April 2009, Paris, France. This study was commissioned by the Board of Directors of the ISHLT and approved at all stages by the Education Committee of the ISHLT.

PII: S1053-2498(09)00318-0

doi: 10.1016/j.healun.2009.05.001

The Journal of Heart and Lung Transplantation
Volume 28, Issue 7 , Pages 655-660 , July 2009