Comparative pharmacokinetic study of two mycophenolate mofetil formulations in stable kidney transplant recipients

We compared steady-state pharmacokinetics of mycophenolate mofetil (MMF) – Myfenax^® (Teva) and CellCept^® (Roche) – in stable kidney transplant recipients (KTRs). This was an international, multi-centre, randomized, open-label, two-treatment, two-sequence crossover study with a 3-month follow-up. We included KTRs at least 12 months post-transplantation with stable renal graft function for at least 3 months. The maintenance treatment consisted of MMF in combination with tacrolimus with or without steroids. At the end of the two treatment periods, 6-h or 12-h PK studies of mycophenolic acid (MPA) were performed. A total of 43 patients (mean age: 50.7 ± 13.5 years; 19 females, 24 males) were randomized. Estimates of test to reference ratios (90% CIs) were 0.959 (0.899; 1.023) h*μg/ml for AUC_(0–tau) and 0.873 (0.787; 0.968) μg/ml for C_max. Estimates for AUC_(0–6h) were 0.923 (0.865; 0.984) h*μg/ml and 0.985 (0.877; 1.106) μg/ml for C_min. Thus, AUC_(0–tau), AUC_(0–6h), and C_min of MPA were within the predefined margins. C_max was somewhat outside of these margins in this set of patients. The numbers and types of adverse events were not different between the two treatments. The steady-state pharmacokinetics of MPA as well as adverse events are comparable for Myfenax^® and CellCept^® in tacrolimus-treated stable KTRs. (EudraCT-No.: 2009-010562-31; ClinicalTrials.Gov number: NCT00991510) (read more) Print this post