Safety considerations with mycophenolate sodium.

Following 10 years of clinical use of mycophenolate mofetil (MMF), a prodrug of mycophenolic acid, the FDA has approved enteric-coated mycophenolate sodium (EC-MPS). EC-MPS was developed to reduce the upper-gastrointestinal (GI) effects of MMF. Unlike oral MMF, where absorption starts in the stomach, EC-MPS releases MPA in the small intestine. Along with the pharmacology and pharmacokinetics, three randomized, controlled clinical trials in solid-organ transplantation, comparing MMF and EC-MPS, are reviewed. Disappointingly, EC-MPS was similar to MMF in efficacy and safety and did not significantly improve the GI side effects. Moreover, bioequivalence dosing has only been established with concomitant ciclosporin. The pharmacokinetic characteristics must be studied in greater detail. EC-MPS is a safe and effective immunosuppressive agent approved for use in the prevention of acute rejection after renal transplantation. However, the anticipated improvement of GI side effects has not been forthcoming.