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Published on: November 8, 2015

Safety considerations with mycophenolate sodium

Guido Filler1, Ilan Buffo

  • 1The University of Western Ontario, Department of Paediatrics, Children's Hospital of Western Ontario, Schulich School of Medicine & Dentistry, London, Ontario, Canada. guido.filler@lhsc.on.ca

Expert Opinion on Drug Safety
|August 11, 2007
PubMed

Insights

Enteric-coated mycophenolate sodium (EC-MPS) offers no significant gastrointestinal (GI) benefit over mycophenolate mofetil (MMF) in transplant patients. Both immunosuppressants demonstrate similar efficacy and safety profiles.

Area of Science:

  • Immunology
  • Pharmacology
  • Transplantation Medicine

Background:

  • Mycophenolate mofetil (MMF) has been widely used for over a decade.
  • Enteric-coated mycophenolate sodium (EC-MPS) was developed as an alternative to MMF.
  • EC-MPS aims to reduce upper gastrointestinal (GI) side effects by releasing mycophenolic acid (MPA) in the small intestine, unlike MMF which absorbs in the stomach.

Purpose of the Study:

  • To review the pharmacology, pharmacokinetics, and clinical trial data comparing EC-MPS and MMF.
  • To evaluate the efficacy, safety, and GI tolerability of EC-MPS versus MMF in solid-organ transplantation.

Main Methods:

  • Review of three randomized, controlled clinical trials comparing MMF and EC-MPS.
  • Analysis of pharmacological and pharmacokinetic data for both agents.

Main Results:

  • EC-MPS demonstrated similar efficacy and safety compared to MMF.
  • No significant improvement in GI side effects was observed with EC-MPS.
  • Bioequivalence dosing for EC-MPS was only established when co-administered with cyclosporine.

Conclusions:

  • EC-MPS is a safe and effective immunosuppressant for preventing acute rejection in renal transplantation.
  • The anticipated reduction in GI side effects with EC-MPS was not realized.
  • Further pharmacokinetic studies are needed for EC-MPS.

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