Neoral-to-Gengraf conversion in renal transplant recipients

Our objective was to evaluate the safety, efficacy, and need for dosage adjustments when patients taking the Neoral formulation of cyclosporine are converted to the generic formulation, Gengraf.

From September 2001 through January 2002, patients receiving follow-up care in the renal transplant clinic at the VA Tennessee Valley Healthcare System were converted from Neoral to Gengraf based on a 1:1 dosing equivalency. Steady-state cyclosporine trough concentrations were obtained both prior to and following Neoral-to-Gengraf conversions. Patients were also monitored for changes in serum creatinine, hospitalization, cyclosporine toxicity, graft rejection, and need for further adjustment in cyclosporine regimen.

Forty-one patients were included in data analysis. There were no differences in cyclosporine concentrations (P =.0853) or serum creatinine (P =.4469) following conversion to Gengraf. There were no reports of cyclosporine toxicity, no episodes of graft rejection, and no need for further dose adjustment related to the generic conversion.

Neoral and Gengraf are therapeutically equivalent cyclosporine formulations, such that renal transplant recipients maintained on Neoral can be safely and effectively converted to the Gengraf formulation based on a 1:1 conversion ratio. The use of Gengraf over Neoral within the Veterans Affairs Healthcare System offers a reduced cost alternative but maintains equal efficacy and outcomes.