Biopsy-proven acute rejection episode, graft loss, death, or lost to follow-up (myfortic = 25.8, MMF = 26.2) Biopsy-proven acute rejection (myfortic = 21.6, MMF = 22.9) Graft loss or death (myfortic = 3.8, MMF = 5.3) Intent-to-treat population (%) 95% confidence interval for efficacy failure (composite variable)=-8.7%, +8.0% myfortic (n=213), MMF (n=210), P=NS Biopsy-proven acute rejection episode, graft loss, death, or lost to follow-up (myfortic = 28.6, MMF = 28.1) Biopsy-proven acute rejection (myfortic = 22.5, MMF = 24.3) Graft loss or death (myfortic = 5.1, MMF = 6.7) Intent-to-treat population (%) myfortic (n=213), MMF (n=210), P=NS
Kidney Transplant Medication - enteric-coated myfortic mycophenolic acid delayed-release tablet





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Efficacy for De Novo Patients


myfortic® Means Efficacy for De Novo Renal Transplant Patients


Proven efficacy after 6 and 12 months of treatment*3-5

0-6 Months

0-12 Months

*ERLB301: A 12-month randomized, double-blind, multicenter parallel study assessing the therapeutic equivalence of myfortic compared with MMF in 423 de novo renal transplant recipients. In total, 213 patients received orally, 720 mg of myfortic twice daily, and 210 patients received orally, 1000 mg of MMF twice daily. Concomitant immunosuppressive therapy includes cyclosporine, USP (MODIFIED), with or without corticosteroids.

myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these 2 products is not equivalent
Salvadori et al is the publication of the pivotal trial ERLB301: a phase III, international, double-blind, randomized, multicenter, 12-month, parallel-group study performed in de novo renal transplant patients
The intent-to-treat (ITT) population included 423 patients who had received a first cadaveric, living related, or unrelated HLA identical donor kidney transplant
213 patients were randomized to myfortic (720 mg bid) and 210 to MMF (1000 mg bid)
There were no statistically significant differences between myfortic and MMF in the efficacy parameters measured

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