QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Résumé Extracto Full Text PDF Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Articles Ahead of Print [Order Reprint] Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gabardi, S. Articles by Clarkson, M. R Search for Related Content PubMed PubMed Citation Articles by Gabardi, S. Articles by Clarkson, M. R

NEW DRUG DEVELOPMENTS

Enteric-Coated Mycophenolate Sodium

Renal Transplant Clinical Specialist, Department of Pharmacy Services, Brigham and Women's Hospital; Assistant Clinical Professor, Department of Pharmacy Practice, Bouvé College of Pharmacy, Northeastern University, Boston, MA

Jennifer L Tran

Student, Bouvé College of Pharmacy, Northeastern University

Michael R Clarkson, MD

Renal Fellow, Department of Nephrology, Brigham and Women's Hospital

Reprints: Steven Gabardi PharmD, Department of Pharmacy Services, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115-6110, FAX 617/566-2396, sgabardi{at}partners.org

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of mycophenolate sodium.

DATA SOURCES: Primary literature was obtained via a MEDLINE search (1966–June 2003). Abstracts were obtained from the manufacturer and included in the analysis.

STUDY SELECTION AND DATA EXTRACTION: All studies and abstracts evaluating mycophenolate sodium in solid organ transplantation were considered for inclusion. English-language studies and abstracts were selected for inclusion, but were limited to those consisting of human subjects.

DATA SYNTHESIS: Mycophenolate sodium, a mycophenolic acid prodrug, is an inhibitor of T-lymphocyte proliferation. Mycophenolic acid reduces the incidence of acute rejection in renal transplantation. Mycophenolate sodium is enteric coated and has been suggested as a potential method to reduce the gastrointestinal adverse events seen with mycophenolate mofetil. Both mycophenolate mofetil and mycophenolate sodium have been shown to be therapeutically equivalent at decreasing the incidence of allograft rejection and loss. The frequency of adverse events is similar between both compounds, with the most common events being diarrhea and leukopenia.

CONCLUSIONS: Mycophenolate sodium is effective in preventing acute rejection in renal transplant recipients. At doses of 720 mg twice daily, the efficacy and safety profiles are similar to those of mycophenolate mofetil 1000 mg twice daily. Mycophenolate sodium has been approved in Switzerland; approval in the US is pending.

Key Words: EC-MPS, ERL, ERL080, MPS, mycophenolate sodium, mycophenolic acid, renal transplantation, solid organ transplantation

Published Online, October 3, 2003. www.theannals.com, DOI 10.1345/aph.1D063

This article has been cited by other articles:

				M Hartmann and A Enk Mycophenolate mofetil and skin diseases Lupus, March 1, 2005; 14(3_suppl): s58 - s63. [Abstract] [PDF]

				M. Hartmann and A. Enk Mycophenolate mofetil and skin diseases Lupus, January 1, 2005; 14(1_suppl): s58 - s63. [Abstract] [PDF]

				R. G Morris Immunosuppressant Drug Monitoring: Is the Laboratory Meeting Clinical Expectations? Ann. Pharmacother., January 1, 2005; 39(1): 119 - 127. [Abstract] [Full Text] [PDF]

				P. F. Halloran Immunosuppressive Drugs for Kidney Transplantation N. Engl. J. Med., December 23, 2004; 351(26): 2715 - 2729. [Full Text] [PDF]