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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ISHLT Working Formulation of a Standardized Nomenclature for Cardiac Allograft Vasculopathy—2010
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The 2015 ISHLT Guidelines for the Management of Fungal Infections in Mechanical Circulatory Support and Cardiothoracic Organ Transplant Recipients: Executive Summary
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2009 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension
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Report from a Consensus Conference on Primary Graft Dysfunction after Cardiac Transplantation
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2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure