Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients

Immunosuppressive drugs for solid organ transplantation are critical dose drugs with a narrow therapeutic index. Many of the most commonly used innovator drugs are off patent and have been replicated by generic counterparts, often at substantial cost-savings to the patient. However, serious adverse events caused by the transition from innovator to generic medications, specifically in pediatric solid organ transplant recipients, have questioned these autosubstitutions. The purpose of this review is to summarize the criteria set forth by the regulatory bodies, and to examine how major immunosuppressive drugs conform to these recommendations. Regulatory bodies have established inconsistent criteria to demonstrate bioequivalence between innovator and generic medications, causing approved generic variations to have varying levels of equivalence with the innovator drugs. In order to minimize the risk for under-immunosuppression, the following recommendations have been concluded. Brand prescribing of cyclosporine and tacrolimus are recommended due to evidence of adverse events after conversion to generic formulations and differences in dissolution parameters. Mycophenolate mofetil (MMF) shows better bioequivalence between innovator and generic formulations, however caution should be advised when switching between formulations. The institution of 'innovator only' policies may be appropriate at this time in order to minimize the risk of under-immunosuppressing patients until the evidence of more stringent bioequivalence has been established.

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Generic immunosuppressants

Medeiros-Domingo

Lumini

Stern

et al. 2017

Pediatr Nephrol

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Report from the 2018 consensus conference on immunomodulating agents in thoracic transplantation: Access, formulations, generics, therapeutic drug monitoring, and special populations

Cochrane

Lyster

Lindenfeld

et al. 2020

The Journal of Heart and Lung Transplantation

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WITHDRAWN: Executive Summary - The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients

Dhital

Azeka

Colvin

et al. 2022

The Journal of Heart and Lung Transplantation

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Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients

Abstract: Switching to MT and/or TS several years after heart transplantation appeared safe in the short-term perspective, showing no detectable changes in tacrolimus C0 levels, safety or efficacy, during an average follow-up of six months.

Cited by 5 publications

References 29 publications

Generic immunosuppressants

Generic immunosuppressants

Report from the 2018 consensus conference on immunomodulating agents in thoracic transplantation: Access, formulations, generics, therapeutic drug monitoring, and special populations

WITHDRAWN: Executive Summary - The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients

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