Biopsy-proven acute rejection episode, graft loss, death, or lost to follow-up (myfortic = 4.4, MMF = 6.7) Biopsy-proven acute rejection (myfortic = 1.3, MMF = 1.2) Graft loss or death (myfortic = 0.0, MMF = 1.2) Intent-to-treat population (%) 95% confidence interval for efficacy failure (composite variable)=-7.4%, +2.7% myfortic (n=159), MMF (n=163), P=NS Biopsy-proven acute rejection episode, graft loss, death, or lost to follow-up (myfortic = 7.5, MMF = 12.3) Biopsy-proven acute rejection (myfortic = 1.3, MMF = 3.1) Graft loss or death (myfortic = 1.3, MMF = 3.1) 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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myfortic: Comparable Efficacy


Efficacy Maintained After Conversion to myfortic®


Stable MMF patients converted to myfortic show comparable efficacy*1-3

0-6 Months

0-12 Months

*ERLB302: A 12-month, randomized, double-blind, double-dummy, multicenter, parallel-group study assessing the safety, tolerability, and efficacy of myfortic compared with MMF in 211 maintenance stable renal transplant recipients, who were at least 6 months post-renal transplantation. Patients included in study were receiving 100 mg of MMF orally, twice daily with cyclosporine, USP [modified] (Neoral®), with or without corticosteroids. 159 stable renal transplant patients were converted to 720 mg of myfortic orally, twice daily, and 163 stable renal transplant patients were maintained on their current regimen of 1000 mg of MMF orally, twice daily. Concomitant immunosuppressive therapy included 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
Budde et al is the publication of the pivotal trial ERLB302; a phase III, international double-blind, randomized, multicenter, double dummy, 12-month parallel-group study was performed in stable maintenance renal transplant patients taking MMF (2 weeks before randomization). Patients were randomized to receive myfortic (720 mg bid; n=159) or continue receiving MMF (1000 mg bid; n=163)
The intent-to-treat (ITT) population included 322 patients who had received a first or second cadaveric, living unrelated, or living related donor kidney transplant at least 6 months previously
The overall efficacy results of this study clearly confirm that myfortic is as effective as MMF. Converting patients receiving MMF to myfortic did not jeopardize efficacy

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