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Enteric-coated mycophenolate sodium for transplant immunosuppression
1National Institute of Transplantation (NIT), St. Vincent Medical Center, Los Angeles, CA 90057, USA.
Summary
Enteric-coated mycophenolate sodium (EC-MPS) is a safe and effective immunosuppressant for preventing kidney transplant rejection. It offers similar efficacy and safety to mycophenolate mofetil with potentially reduced gastrointestinal side effects.
Area of Science:
- Pharmacology and pharmacokinetics of novel immunosuppressive agents.
- Drug development for organ transplantation.
Background:
- Enteric-coated mycophenolate sodium (EC-MPS) is a prodrug of mycophenolic acid (MPA).
- EC-MPS was developed to mitigate upper gastrointestinal adverse effects associated with mycophenolate mofetil (MMF).
- Unlike MMF, EC-MPS releases MPA in the small intestine, potentially improving tolerability.
Purpose of the Study:
- To review the pharmacology, pharmacokinetics, drug interactions, clinical efficacy, safety, and administration of EC-MPS.
- To evaluate EC-MPS as an alternative immunosuppressive agent in renal transplantation.
Main Methods:
- Review of pharmacological and clinical data for EC-MPS.
- Analysis of Phase III clinical trials comparing EC-MPS to MMF in renal transplant recipients.
- Assessment of pharmacokinetic and safety profiles.
Main Results:
- EC-MPS demonstrates 72% absolute bioavailability with MPA half-life of 8-16 hours.
- MPA is primarily metabolized to MPAG and excreted in urine.
- Phase III trials show comparable efficacy and safety to MMF, with one study reporting improved quality of life.
Conclusions:
- EC-MPS is a safe and effective immunosuppressant for preventing acute rejection post-renal transplantation.
- EC-MPS provides an alternative option for immunosuppression in transplant patients.
- Further Phase IV studies aim to elucidate additional benefits of EC-MPS.