Generic Tacrolimus in Kidney Transplant Patients at Jordan University Hospital

Abstract

Background: Tacrolimus is the immunosuppressive drug of choice for kidney transplant patients, but its cost is very high in the total drug cost for patients with renal disease. Lower drug costs can be achieved with generic tacrolimus. For this reason, the Ministry of Health mandated to implementation of a switch to generic form and so we wanted to evaluate whether a switch could be safely performed and to observe the effect of this on kidney function. Subjects and Methods: In this observational study, 28 stable kidney transplant patients taking Prograf®(Astellas) were switched to a generic Pangraf®(Pancea) in a 1:1 dose ratio and were followed up for 6 months. Plasma creatinine levels and trough concentrations of tacrolimus were recorded three times on Prograf® and weekly for 4 weeks, then monthly after conversion to Pangraf®. Results: Tacrolimus mean C0 levels were 6.97 ± 0.92 ng/mL before and 7.4 ± 1.23 ng/mL after conversion (P = 0.22). Mean serum creatinine values were 1.13 ± 0.53 mg/dL and 1.15 ± 0.54 mg/dL before and after conversion, respectively (P = 0.27). Conclusion: Switching from branded tacrolimus to generic tacrolimus seems possible and safe, but close monitoring is essential.