What is it about?
Most immunosuppressants (or anti-rejection drugs) are so-called critical dose drugs. Sometimes they are also called narrow therapeutic index drugs. Narrow therapeutic index drugs are drugs where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity. Many innovator immunosuppressants have come or will soon come off patent protection, so that cheaper generic drugs can be manufactured. However, regulatory requirements vary widely and major markets such as the United States of America have no special requirements for the license. Bioequivalence (similar drug exposure for a given dose) is not tested in real patients. Healthcare funding organizations and pharmacies assume bioequivalence and are often substituting different formulations to save costs, however, this may lead to underdosing and rejection and possibly even graft loss.
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Why is it important?
A solid organ transplant is a precious gift that must be maintained. The patients should be maintained on one formulation. For now, based on the limited evidence, the authors cannot recommend switching between different tacrolimus or cyclosporine formulations.
Perspectives
Normally, generic drugs are a cheap alternative to the innovator drug. Unfortunately, the rigor for approving critical dose drugs varies widely among different countries and available generic immunosuppressants which are almost all critical dose drugs are prone to causing underexposure and rejection in transplant patients. This review describes which immunosuppressants can and which ones cannot be substituted.
Professor Guido Filler
Western University
Read the Original
This page is a summary of: The problem with generic immunosuppressants, Pediatric Transplantation, August 2014, Wiley,
DOI: 10.1111/petr.12272.
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