Immunosuppressive regimens containing generic mycophenolate mofetil (Myfenax) in de novo renal transplant recipients – preliminary results of 6-month observation
Bolesław Rutkowski, Beata Bzoma, Alicja Dębska-Ślizień, Andrzej Chamienia
Ann Transplant 2011; 16(4): 74-80
Background: The aim of the findings presented below is to show the preliminary outcomes of transplantation in patients treated with the generic formulation of mycophenolate mofetil (Myfenax, Teva).
Material/Methods: Over the past 2 years 34 patients received generic mycophenolate mofetil (Myfenax) after renal transplantation at the Gdansk Transplantology Center. During the same time period another 127 kidney transplantations were performed in our Department and these patients were treated with other formulations of mycophenolate (CellCept, Myfortic or Mycophenolate mofetil Apotex) as a part of the immunosuppressive scheme. Fifteen of the Myfenax patients received a pair of kidneys from the same donor and received original mycophenolate mofetil Cell-Cept.
Results: The outcomes of the renal transplants in both groups (Myfenax vs. pair) were good; with satisfactory function of grafts, and no instances of graft loss were reported. There was no difference in the incidence of acute renal graft rejection (AR) in either group. Moderate adverse reactions to immunosupression were observed in both groups.
On the other hand, a comparison between the 34 patients with Myfenax and the 127 other patients with other formulations of mycophenolate revealed no differences in the incidence of AR, delayed graft function (DGF), graft loss and death.
Conclusions: There were no differences in the incidence of AR, DGF, graft loss and death in patients with Myfenax vs. original CellCept and other formulations of mycophenolate.
In order to confirm its complete biological and pharmacokinetic equivalence with the reference medicine, long-term, randomized observations carried out on larger renal transplant patients groups are needed.
Keywords: immunosupressive therapy, kidney tranplantation, mycophenolate