Advances in TransplantationLiver transplantationEfficacy and Safety of Generic Mycophenolate Mofetil (My-rept) 500-Milligram Tablets in Primary Liver Transplant Recipients

•This study was a single-center, open-label, noncomparative, phase 4 clinical trial evaluating the efficacy and safety of 500-mg My-rept tablets in primary LT patients.•All enrolled patients and their liver grafts had survived for 24 weeks post-transplantation with no episodes of acute rejection.•Nine patients (18.8%) presented with ADRs that had been commonly reported with the use of other MMF products, and no serious ADRs were reported.•The bioequivalent 500-mg My-rept tablet is efficient, safe, cost-effective, and convenient for patients after LT.

BackgroundGeneric immunosuppressants may be cost-effective if clinical outcomes are equivalent to the brand-name medications. Mycophenolate mofetil in the form of My-rept may be cost-effective being a generic immunosuppressant, which is available as a 500-mg tablet as well as a 250-mg capsule (Chong Kun Dang Pharmaceutical Corporation, Seoul, Korea).ObjectiveThis study aimed to evaluate the efficacy, safety, cost-effectiveness, and convenience of My-rept 500-mg tablets in liver transplant recipients.SettingThe setting was an outpatient liver transplantation clinic of a tertiary hospital in Korea.MethodA phase 4, single-center, open-label, noncomparative study was undertaken. A total of 50 patients were recruited. Acute transplant rejection, changes in blood chemistry, white blood cell count, assessments of renal function, occurrence of adverse drug reactions, and other characteristics of the patients were recorded for 24 weeks. After study termination, a satisfaction survey was conducted.ResultsAll enrolled patients and their liver grafts had survived for 24 weeks post-transplantation. No episodes of acute rejection were reported. Nine patients (18.8%) presented with adverse drug reactions that had been commonly reported with the use of other mycophenolate mofetil products, and no serious adverse drug reactions were reported.ConclusionIn conclusion, the My-rept 500-mg tablet appears to be feasible and convenient for administration to recipients of a liver transplant.