Budde, Klemens, Tedesco-Silva, Helio, Pestana, Jose Medina, Glander, Petra, Neumayer, Hans-H, Felipe, Claudia Rosso, Machado, Paula Pinheiro, Sechaud, Romain and Schmouder, Robert (2007) Enteric-coated mycophenolate sodium provides higher mycophenolic acid predose levels compared with mycophenolate mofetil: implications for therapeutic drug monitoring. Therapeutic drug monitoring, 29 (3). pp. 381-384. ISSN 0163-4356

Abstract

The delayed release of mycophenolic acid (MPA) from enteric-coated mycophenolate sodium (EC-MPS) may lead to different MPA predose (C0) levels compared with mycophenolate mofetil (MMF). A post hoc analysis was performed on MPA morning predose values assessed in 88 maintenance renal transplant patients from three studies converted from MMF (1000 mg twice a day) to equimolar EC-MPS (720 mg twice a day) or vice versa, both in combination with cyclosporine. The median MPA predose level was approximately 30% higher when patients received EC-MPS (2.40 microg/mL; range, 0.49-39.30 microg/mL) compared with MMF (1.83 microg/mL; range, <0.1-12.80 microg/mL). Rare cases (3.0%) of high MPA C0 levels 15 microg/mL or greater were observed with EC-MPS consistent with a very prolonged release of MPA from this formulation. Both EC-MPS and MMF exhibited a poor correlation between MPA C0 levels and exposure as assessed by MPA area under the curve. Physicians targeting a certain MPA predose level have to be aware of the higher morning C0 levels with EC-MPS, whereas the overall MPA exposure is not different to MMF.

Item Type:	Article
Date Deposited:	05 Oct 2012 23:45
Last Modified:	05 Oct 2012 23:45
URI:	https://oak.novartis.com/id/eprint/8693