Generic Drug Immunosuppression in Thoracic Transplantation
An ISHLT Educational Advisory
Published 4 June 2009
Patricia A. Uber, PharmD; Heather J. Ross, MD; Andreas O. Zuckermann, MD; Stuart C. Sweet, MD; Paul A. Corris, MD; Keith McNeil, MD; Mandeep R. Mehra, MBBS
J Heart Lung Transplant. 2009 July; 28(7):655-660.
The 1990s ushered in approval of several novel immunosuppressant drugs, including mycophenolate mofetil, tacrolimus, cyclosporine microemulsion, everolimus and sirolimus, with consequent improvement in clinical outcomes. Subsequently, the transplant community has been challenged with the development and introduction of generic immunosuppression drugs. These drugs represent a narrow therapeutic index and are thus classified as critical-dose agents. Sengai Gibon, a Japanese zen monk, wrote “Whether for life, whether for death—(it depends on) the right spoon-measure.”
The purpose of this educational advisory from 2009 was to provide an international perspective on regulatory and clinical concerns with generic immunosuppression medications in thoracic transplantation.
Read at JHLTRelated Guidlines
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Report from a Consensus Conference on Primary Graft Dysfunction after Cardiac Transplantation
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Present Status of Research on Psychosocial Outcomes in Cardiothoracic Transplantation— Review and Recommendations for the Field
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ISHLT Working Formulation of a Standardized Nomenclature for Cardiac Allograft Vasculopathy—2010
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Destination Mechanical Circulatory Support: Proposal for Clinical Standards
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Chronic Lung Allograft Dysfunction: Definition and Update of Restrictive Allograft Syndrome