Enteric-coated mycophenolate sodium.
OBJECTIVE
To review the pharmacology, pharmacokinetics, efficacy, and safety of mycophenolate sodium.


METHODS
Primary literature was obtained via a MEDLINE search (1966-June 2003). Abstracts were obtained from the manufacturer and included in the analysis.


METHODS
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.


RESULTS
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.
Gabardi
Steven
S
Department of Pharmacy Services, Brigham and Women's Hospital, Boston, MA 02115-6110, USA. sgabardi@partners.org
Tran
Jennifer L
JL
Clarkson
Michael R
MR
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D004347:Drug Interactions; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use*; D011355:Prodrugs / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D013608:Tablets, Enteric-Coated
D007166:Immunosuppressive Agents; D011355:Prodrugs; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid