A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport^®or Prograf^®preparations of tacrolimus

Abstract

BackgroundThe use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf®) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf® to a generic formulation (Adoport®) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf® with those receiving Adoport®.MethodsData regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed.ResultsA total of 48 patients received Prograf® and 51 received Adoport®. At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups.ConclusionsThis is the first study to compare the clinical outcomes of patients receiving Adoport® with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf® or Adoport® from the time of renal transplantation. These early outcome data therefore support the use of Adoport® in place of Prograf® as a potential cost-saving measure.

De novo use of generic tacrolimus in liver transplantation – a single center experience with one‐yr follow‐up

“…While no clear relationship between tacrolimus levels and the incidence of AKI could be determined in the adoport-treated recipients, the finding of statistically higher variability in dose/level ratio at day 14 does raise the possibility that adoport levels may have fluctuated enough to cause renal impairment. A similar finding was shown by Connor et al (16), who also demonstrated a non-significantly increased frequency of tacrolimus-related nephrotoxicity in adoport-treated renal transplant patients compared to historical controls treated with Prograf. However, at later time points, we were unable to either show variation in dose/level ratios or renal function suggesting that even if variation in the pharmacokinetics of Adoport predisposes to AKI in the early-phase post-LT, this is short lived and not associated with changes in long-term renal outcomes.…”

Immunosuppression with generic tacrolimus in liver and kidney transplantation—systematic review and meta‐analysis on biopsy‐proven acute rejection and bioequivalence

“…Similar patient and graft survival was reported in the selected studies. Graft loss was reported in two of the de novo studies after KT: in eight patients (15.7%) versus six patients (12.5 %) after generic and innovator Tac, respectively , and the Spartacus trial revealed 0% graft loss versus 2.6% (one patient) with generic and innovator Tac after KT, respectively . Furthermore, there were 2 (4.3%) versus no graft losses reported with de novo innovator Tac after LT .…”

De novouse of a generic formulation of tacrolimus versus reference tacrolimus in kidney transplantation: evaluation of the clinical results, histology in protocol biopsies, and immunological monitoring

“…In 2011, the tacrolimus produced by Sandoz under the name of Adoport â officially entered the market in Europe after being approved by the European Medicines Agency. Since then, many authors have performed clinical studies to test the efficacy and safety of Adoport â in different situations: conversion studies from Prograf â to Adoport â [16][17][18], as well as de novo use [19] and bioequivalence studies (postconversion) [20].…”