Immunosuppressive regimens containing generic mycophenolate mofetil (Myfenax) in de novo renal transplant recipients--preliminary results of 6-month observation.
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).


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.
Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk, Debinski 7 St., Gdansk, Poland. bolo@amg.gda.pl
Bolesław
B
Rutkowski
Beata
B
Bzoma
Alicja
A
Dębska-Ślizień
Andrzej
A
Chamienia
D000328:Adult; D000368:Aged; D051799:Delayed Graft Function / Q000209:etiology; D016568:Drugs, Generic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D013810:Therapeutic Equivalency; D013997:Time Factors; D016896:Treatment Outcome
D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid