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
-
2019 Updated Consensus Statement on the Diagnosis and Treatment of Pediatric Pulmonary Hypertension
-
2009 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension
-
The 2016 ISHLT Listing Criteria for Heart Transplantation: A 10-year Update
-
HFSA/SAEM/ISHLT Clinical Expert Consensus Document on the Emergency Management of Patients with Ventricular Assist Devices
-
ISHLT Advisory Statement on the Implications of Pandemic Influenza for Thoracic Organ Transplantation