Impact of Switching from Brand Formulation to Generic Tacrolimus in Renal Transplant Recipients
Mesfer Alghamdi, Bassam Alanazi, Alharbi Sh, Bassem A. Almaki, Turkiah AlotaibiAbstract
Background:
Tacrolimus is essential in renal transplant immunosuppression but has a narrow therapeutic index, requiring careful monitoring during formulation changes. Concerns persist about maintaining therapeutic levels and clinical outcomes when converting to generic formulations.
Aim:
To assess the clinical outcomes of renal transplant recipients following conversion from brand-name tacrolimus (Prograf) to its generic formulation (Rolitac), including tacrolimus levels, renal function, and safety.
Materials and Methods:
This retrospective, single-center cohort study was conducted at a tertiary hospital over 12 months in renal transplant recipients (≥18 years) at least 1 year post-transplant. Baseline demographics, transplant history, comorbidities, and tacrolimus regimens were collected. Patients had three follow-up visits monitoring tacrolimus trough levels, renal function [serum creatinine, estimated glomerular filtration rate (eGFR)], acute rejection, and adverse drug reactions. Analyses used SPSS 28.0.1, with significance set at
Results:
Sixty patients (mean age 43.7 ± 12.9 years, 66.7% male) were included. Tacrolimus trough levels remained stable throughout the 12-month follow-up. Serum creatinine increased (
Conclusion:
Conversion of stable renal transplant recipients from brand-name to generic tacrolimus can be implemented with vigilant monitoring, and the renal function changes underscore the importance of close follow-up and individualized dosing. In the absence of a concurrent comparator group and given the short follow-up, these changes cannot be causally attributed to the switch and require confirmation in controlled studies with longer follow-up.