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Objective: Tacrolimus (TAC), the mainstay immunosuppressive drug in kidney transplantation, is a narrow therapeutic index drug and has strict bioequivalence (BE) acceptance criteria adopted by regulatory agencies. Possible acute rejection resulting from the use of a generic drug is the main matter of concern for responsible physicians. We aimed to show the possible differences in drug dosages and serum concentrations and to share our experience on this subject.
Methods: We retrospectively screened all the patients who underwent living-related kidney transplantation between January 2016 and August 2020. There were 106 patients in the Prograf® group and 39 patients in the Adoport® group. We investigated the demographics, daily drug dosages of TAC (mg/day and mg/body weight (kg)/day), TAC trough levels (TTL), renal functions, biopsy-proven acute rejections, post-transplant complications (hypertension, diabetes, cytomegalovirus and BK replication), graft survival, and patient survival.
Results: The medical records of a total of 145 (47 females, 32%) patients whose mean age was 42.9 ± 12 were retrieved with a follow-up time of 31 (IQR, 19-44) months. Comparisons showed that there was no difference in drug dosages, TTLs, acute rejection, graft loss, and mortality, between the patients who received the generic TAC or the original one, at the end of the follow-up time. In total, 20 biopsy-proven acute rejections were seen (17, 16% in the Prograf® group and 3, 7% in the Adoport® group; P = .213). We found that although the drug levels and dosages were the same, creatinine and proteinuria were slightly higher in the Prograf® group in the first and second months. This difference was lost at subsequent time periods.
Conclusion: We concluded that the use of generic TAC in living-related kidney transplantation is a safe move, with efficacy and acceptable outcomes similar to the use of the original brand.
Cite this article as: Sadioğlu RE, Karaoğlan M, Aktar M, et al. Outcomes of de novo use of generic tacrolimus (Adoport®) in living-related kidney transplantation: A single-center, real-life experience of 5 years. Turk J Nephrol. 2021; 30(4): 255-261.