title: Review of the immunosuppressant enteric-coated mycophenolate sodium.
abstract: Enteric-coated mycophenolate sodium (EC-MPS; myfortic, Novartis Pharma AG) is an advanced formulation delivering mycophenolic acid (MPA). EC-MPS was designed to improve MPA-related upper gastrointestinal adverse events by delaying the release of MPA until reaching the small intestine. At a dose of 720 mg, EC-MPS exhibits equivalent MPA exposure (area under the concentration curve [AUC]) and maximal MPA concentration (C(max)) to mycophenolate mofetil (MMF; CellCept, Roche AG) 1000 mg. The time to maximal MPA concentration (T(max)) for EC-MPS is delayed relative to that for MMF, consistent with a functioning enteric coating. EC-MPS 720 mg b.i.d. has demonstrated therapeutic equivalence to MMF 1000 mg b.i.d. in renal transplant patients. Recent clinical trials have demonstrated that EC-MPS is as effective and safe as MMF in both de novo and maintenance renal transplant patients. Furthermore, studies have confirmed that maintenance patients can be safely converted from MMF to EC-MPS with no compromise of efficacy or safety. EC-MPS therefore presents physicians and patients with a valid alternative MPA therapy with a comparable efficacy and safety profile to MMF.
authors.affiliation: Humboldt University, Department of Nephrology, Charité, Campus Charité Mitte, Schumannstrasse, D-10117 Berlin, Germany. klemens.budde@charite.de
authors.forename: Klemens
authors.initials: K
authors.lastname: Budde
authors.forename: Petra
authors.initials: P
authors.lastname: Glander
authors.forename: Fritz
authors.initials: F
authors.lastname: Diekmann
authors.forename: Johannes
authors.initials: J
authors.lastname: Waiser
authors.forename: Lutz
authors.initials: L
authors.lastname: Fritsche
authors.forename: Duska
authors.initials: D
authors.lastname: Dragun
authors.forename: Hans-Hellmut
authors.initials: HH
authors.lastname: Neumayer
mesh_terms: D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid