STABIL-study: The Course of Therapy, Safety and Pharmacokinetic Parameters of Conversion of Prograf® to Tacrolimus HEXAL®/Crilomus® in Renal Transplant Recipients – an Observational Study in Germany

Title:STABIL-study: The Course of Therapy, Safety and Pharmacokinetic Parameters of Conversion of Prograf® to Tacrolimus HEXAL®/Crilomus® in Renal Transplant Recipients – an Observational Study in Germany

Volume: 16 Issue: 4

Author(s): Lukas J. Lehner*, Klaus Kalb, Karl Weigand, Ulrich Pein, Peter Schenker, Wolfgang Seeger, Robert Roehle, Kerstin Dienes, Fabian Halleck and Klemens Budde

Affiliation:

• Department of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin,Germany

Keywords: Renal transplant, immunosuppression, generic, tacrolimus, trough levels, conversion.

Abstract:

Background/Objective: Tacrolimus HEXAL®/Crilomus® is an approved generic immunosuppressant for the prevention and treatment of rejection following renal transplantation. For safe and socioeconomically efficient conversion of the innovator into a generic formulation, high- -quality data are necessary, in view of the different and country-specific comorbidities and pharmacokinetics in kidney transplant recipients.

Patients and Methods: From 2014 to 2017, we enrolled 32 kidney transplant recipients, receiving newly prescribed Tacrolimus HEXAL®/Crilomus® in 5 German centers. Efficacy and safety data were collected over 6-8 months and retrospectively compared to the period prior to conversion.

Results: The mean tacrolimus trough level was 4.91 ng/mL Standard Deviation (SD) (SD ±1.7) before and 5.06 ng/mL (SD ±1.97) after conversion. Mean tacrolimus trough concentration-dose-ratio (+/- SD) was 187.1 ng/mL/mg/kg/day (SD 99.2) for the reference and 205.1 ng/mL/mg/kg/day (SD 133) for the generic product, resulting in a non-significant difference of 18.0 ng/mL/mg/kg/day (SD 71.8) (p=0.84, Wilcoxon V=180). Overall, dosing had to be changed in 4 (14.8%) patients. Graft function remained stable and no rejections occurred.

Conclusion: In conclusion, conversion to the generic tacrolimus formulation can be considered safe and feasible in long-term kidney transplant recipients in Germany. As suggested by guidelines, vigilant therapeutic drug monitoring is recommended to account for possible tacrolimus concentration variability on the individual patient level.

Cite this article as:

Lehner J. Lukas *, Kalb Klaus , Weigand Karl , Pein Ulrich , Schenker Peter , Seeger Wolfgang , Roehle Robert , Dienes Kerstin , Halleck Fabian and Budde Klemens , STABIL-study: The Course of Therapy, Safety and Pharmacokinetic Parameters of Conversion of Prograf® to Tacrolimus HEXAL®/Crilomus® in Renal Transplant Recipients – an Observational Study in Germany, Current Reviews in Clinical and Experimental Pharmacology 2021; 16 (4) . https://dx.doi.org/10.2174/1574884716666210215102756