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Updated: May 28, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
Generic maintenance immunosuppression in solid organ transplant recipients.
Christopher R Ensor1, Jennifer Trofe-Clark, Steven Gabardi
1Comprehensive Transplant Center, The Johns Hopkins Hospital, University of Maryland School of Pharmacy, Baltimore, Maryland, USA. censor1@jhmi.edu
Generic immunosuppressants, like tacrolimus and mycophenolate mofetil, can be safely used in solid organ transplant recipients. Consistent product use, awareness of substitutions, and enhanced drug monitoring are key for safe generic immunosuppression transitions.
Area of Science:
- Immunology
- Pharmacology
- Transplantation Medicine
Background:
- Solid organ transplant survival has improved with tacrolimus and mycophenolate use.
- These immunosuppressants offer greater potency and specificity than older drugs.
- Generic formulations of tacrolimus and mycophenolate mofetil were approved between 2008-2010.
Purpose of the Study:
- To address clinical concerns regarding the substitution of generic immunosuppressants for innovator products.
- To summarize expert opinions and consensus statements on generic immunosuppression in transplantation.
- To analyze the impact of generic substitution and affected populations.
Main Methods:
- Review of concerns regarding generic immunosuppression.
- Analysis of expert opinion and consensus statements.
- Evaluation of market penetration and formulary considerations.
Main Results:
- Generic substitution presents a clinical dilemma similar to previous cyclosporine generic availability.
- Formulary issues include cost, availability, and potential for drug errors.
- Patient and transplant coordinator perspectives are crucial.
Conclusions:
- Generic immunosuppressants can be safely substituted for innovator products.
- Consistent patient product use is essential.
- Awareness of substitutions and enhanced therapeutic drug monitoring are recommended during transitions.
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