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

Abstract

Adoport is safe and effective compared to Prograf when used de novo in LT patients. Tacrolimus costs were significantly reduced by the use of Adoport.

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

“…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 . More drug level variability and dose adjustments necessary during the first weeks after transplantation in de novo use and also after conversion was reported .…”

“…Five studies including 365 patients after LT (191 de novo, 174 conversion) and nine studies including 883 patients after KT (735 de novo, and 148 conversion) compared BPAR of patients on generic Tac with those on innovator Tac after LT or KT, all of them in a parallel design (Table ). However, only two of those studies were randomized controlled trials and a further two were non‐randomized prospective studies . Risk ratios for BPAR rates of patients on generic Tac versus innovator Tac were compared in a forest plot stratified visually by organ and study design (Fig.…”

“…A total of 390 publications were excluded during abstract screening. After the elimination of preliminary reports (2), case reports (3), reviews (25), and studies without a control group (16), 17 studies met the inclusion criteria (Fig. ).…”

“…Thus, these parameters are more commonly available after KT and more studies are available for the switch or de novo use of generic Tac after KT in general. Since protocol biopsies are not commonly performed after LT it is more sophisticated to specify AR episodes after LT with less evidence for BPAR episodes after LT. Biopsies are only performed in exceptional cases since clinicians mostly rely on standard liver values and clinical performance . Based on these facts, it is unlikely to see more RCTs on generic Tac with focus on BPAR.…”

Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation

“…Our data are in line with the results of Dannhorn et al who demonstrated a significant reduction of costs with generic TAC by Sandoz in kidney-transplant recipients. 10 Rosenborg et al also found that the conversion from Prograf ® to TAC Sandoz ® after kidney transplantation brought savings, despite costs for extra monitoring. 7 …”