Conversion to Generic Cyclosporine to Formulation in Kidney Transplantation: Experience of a Center in Argentina.

Abstract

Aim: Evaluate the safety and effectiveness of Generic Cyclosporine A in a selected patient population. Methods. We evaluated patients who metthe following criteria: Adults, have obtained a renal transplant at least 6 months prior to the switch to the original formulation, maintain stable cyclosporine dose for at least one month before the change, maintain stable levels of cyclosporine for at least one month before the change, and being clinically stable prior to switch. Generic Cyclosporine was provided by the Heath Ministry of Argentina since 2010. The study was descriptive, retrospective and no randomized. Design Study: Comparison problem related samples. Results. 34 patients were included. All patients received care on an outpatient. The change was 1:1. The average age was 46 years (27/72).21 male and 13 female and graft of 108 months (61.2/175.2). The mean time before replacement was 45 days (SD 36.6) and 63 days post substitution (SD 46.4). Mean levels of creatinine before and after the substitution showed no statistical significant differences (1.53 mg/dl vs 1.46 mg/dl). No differences were found in the levels of the C2 dosages of cyclosporine (516 ng/ml (SD 149) and 502 ng/ml (SD 175).Although blood levels of CSA remained above the target, in 13 patients blood levels were higher ( 20% ) and 21 patients were lower(by 21 %). When blood levels is related to the dose of cyclosporine used (CSA (ng/ml) /(dose mg/kg /day) statistically significant differences were observed (268.7/255.7). Rejection or deaths were no evidenced. Conclusion. Switch to Generic Cyclosporine in stable patients appears to be safe and effective when accompanied by monitoring therapeutic drug.