Generic Drug Immunosuppression in Thoracic Transplantation

An ISHLT Educational Advisory

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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.

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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 JHLT

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