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S. Pollard, B. Nashan, A. Johnston, P. Hoyer, P. Belitsky, P. Keown and H. Helderman, “A Pharmacokinetic and Clinical Review of the Potential Clinical Impact of Using Different Formulations of Cyclosporine A,” Clinical Therapeutics, Vol. 25, No. 6, 2003, pp. 1654-1669. doi:10.1016/S0149-2918(03)80161-3

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• TITLE: How Safe Is Conversion from Tacrolimus to Its Generic Drug?—A Single Center Experience

  AUTHORS: Tobias A. Marsen

  KEYWORDS: Kidney; Pharmacoeconomics; Tacrolimus; Transplantation

  JOURNAL NAME: Open Journal of Nephrology, Vol.2 No.4, December 12, 2012

  ABSTRACT: Background: Generically produced cyclosporine has long been approved in the treatment of organ transplant recipients and several publications have dealt with its use. For tacrolimus, however, very few data exist for safety and efficacy after conversion to its generic in kidney transplant recipients. Methods: In this single-center observational study, 14 kidney transplant carriers were converted to generic tacrolimus as part of aftercare, and graft function, fasting tacrolimus levels and the daily tacrolimus dose was pursued for up to 95 weeks. Results: Average drug doses changed from 3.64 ± 1.88 mg/day with the original to 3.33 ± 1.72 mg/day after conversion to generic tacrolimus (p = 0.33). Tacrolimus fasting levels were 6.23 ± 1.68 ng/ml before and 5.89 ± 1.15 ng/ml after conversion (p = 0.66). Average serum creatinine values of 2.26 ± 1.08 mg/dl after conversion did not differ from previous values of 1.99 ± 0.74 mg/dl (p = 0.15). Conclusions: These data support the assumption, that it is safe to convert stable kidney transplant patients from the original galenic formulation under close scrutiny to the generically produced substance. Conversion is easy to be implemented in the routine follow-up and thus represents an option in the therapy with calcineurin inhibitors, which will contribute to cost reduction in the health system.