Generic formulation of mycophenolate mofetil (Myfenax) in de novo renal transplant recipients: results of 12-month observation.
BACKGROUND
The aim of this study was to show the preliminary outcomes of transplantation in patients treated with the generic formulation of mycophenolate mofetil (Myfenax, Teva).


METHODS
Over the past 4 years, 60 patients received generic mycophenolate mofetil (Myfenax) after renal transplantation at the Gdansk Transplantology Center. During the same time period, another 273 kidney transplantations were performed in our department, and these patients were treated with other formulations of mycophenolate (CellCept [Roche], Myfortic, or mycophenolate mofetil-Apotex) as a part of the immunosuppressive plan. Thirty of the Myfenax patients received a pair of kidneys from the same donor and received original mycophenolate mofetil CellCept with observation for at least 12 months.


RESULTS
The outcomes of the renal transplantations in both groups (Myfenax vs pair) were good, with satisfactory function of grafts. One case of graft loss was reported in the Myfenax group (renal vein thrombosis, graftectomy 5 days after transplantation). There was no difference in the incidence of acute renal graft rejection in either group. Moderate adverse reactions to immunosuppression were observed in both groups. On the other hand, a comparison between the 60 patients with Myfenax and the 273 other patients with other formulations of mycophenolate revealed no differences in the incidence of acute renal graft rejection, delayed graft function, graft loss, and death.


CONCLUSIONS
There were no differences in the incidence of acute renal graft rejection, delayed graft function, graft loss, and death in patients with Myfenax vs original CellCept and other formulations of mycophenolate. 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 Gdańsk, Gdańsk, Poland. Electronic address: bolo@gumed.edu.pl.
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Rutkowski
Department of Nephrology, Transplantology, and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.
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Bzoma
Department of Nephrology, Transplantology, and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.
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Dębska-Ślizień
Department of Nephrology, Transplantology, and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.
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Chamienia
D000293:Adolescent; D000328:Adult; D000368:Aged; D051799:Delayed Graft Function / Q000453:epidemiology / Q000517:prevention & control; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid