A Pilot Study on the Safety and Efficacy of Generic Mycophenolate Agent as Conversion Maintenance Therapy in Stable Liver Transplant Recipients

Purpose

The patent covering mycophenolate mofetil (MMF) in Korea has expired and, thus, several generic MMF agents are now commercially available. The supply of Cellcept (Roche Korea) was interrupted at the end of 2011, so it was inevitable that a generic MMF would be used instead. During this period, we performed a prospective pilot study to examine the safety and efficacy of a generic mycophenolate agent (Myconol: Hanmi Pharmaceutical, Seoul Korea) for use as conversion maintenance therapy in stable liver transplantation (OLT) recipients.

Methods

OLT recipients, who were treated with MMF on an outpatient basis from January 2012 to March 2012, attended follow-up interviews conducted. The patients had undergone OLT ≥ 2 years before the study, had tolerated Cellcept, and showed stable liver function. Fifty-three patients were followed up for more than 3 months after conversion to the same dose of Myconol.

Results

After conversion to Myconol, 6 patients (11.3%) experienced new side effects, which disappeared when they reverted to Cellcept (n = 5) or stopped taking Myconol medication (n = 1). The side effects associated with Myconol included gastrointestinal symptoms (indigestion and diarrhea; n = 3), skin eruptions (n = 1), pruritus (n = 1), and insomnia (n = 1). The mean mycophenolic acid levels were 1.71 ± 0.88 μg/mL for Cellcept and 1.83 ± 0.91 μg/mL for Myconol, which showed a strong correlation (r² = 0.92, P < .001).

Conclusions

Myconol showed similar pharmacokinetics to those of Celcept, but a small proportion of patients experienced agent-specific side effects; therefore, patients should be closely monitored when taking Myconol. Also, further studies, with a greater number of patients, are required to identify the full spectrum of drug-associated side effects.