The Impact of Conversion From Prograf to Generic Tacrolimus in Liver and Kidney Transplant Recipients With Stable Graft Function

Generics: Are all immunosuppression agents created equally?

“…12 Comprehensive data on conversion from generic to brand tacrolimus are not readily available. [18][19][20][21][22] A recent tacrolimus conversion study did identify a significantly lower concentration to dose ratio. 18 This phenomenon was seen in nearly 40% of the kidney transplantation recipients receiving generic tacrolimus.…”

“…[18][19][20][21][22] A recent tacrolimus conversion study did identify a significantly lower concentration to dose ratio. 18 This phenomenon was seen in nearly 40% of the kidney transplantation recipients receiving generic tacrolimus. Two additional studies identified ''similar'' trough levels in conversion from brand to generic tacrolimus but required more frequent dose adjustments.…”

“…Unfortunately, this has not been the real life experience in a market with eight generic forms of tacrolimus. [17][18][19][20][21][22] Patients frequently present having been converted to generics without any notification or explanation by their local pharmacist. In our experience and that of other programs identified multiple long-term stable patients that have presented in acute rejection having been converted by their pharmacist without careful trough monitoring resulting in subtherapeutic trough levels.…”

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“…It was concluded that reference tacrolimus can be safely substituted with the generic product, provided trough concentrations are closely monitored after the substitution. 76 A systematic review and meta-analysis evaluated the clinical efficacy and bioequivalence of generic tacrolimus and Prograf (12 studies) in solid-organ transplant with reference to the outcomes, including patient survival, allograft survival, acute rejection, adverse events, and bioequivalence. Pooled analysis of randomized control trials in patients with RT that reported bioequivalence criteria showed that Prograf (3 studies) was not bioequivalent to generic preparations.…”

Impact of Conversion From Advagraf to Twice-Daily Generic Tacrolimus in Kidney Transplant Recipients: A Single-Center Study

“…It is a potent immunosuppressive drug with a narrow therapeutic index, and several studies have shown that therapeutic drug monitoring contributes with predictive value for the risks of concentration-related rejection and toxicity [1]. A multitude of factors can affect tacrolimus pharmacokinetics, with a high degree of interpatient variability.…”