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Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium.

Kaplan, Bruce and Meier-Kriesche, Herwig-Ulf and Minnick, Paula and Bastien, Marie-Claude and Sechaud, Romain and Yeh, Ching-Ming and Balez, Sebastien and Picard, Franck and Schmouder, Robert (2005) Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium. Clinical transplantation, 19 (4). pp. 551-558. ISSN 0902-0063

Abstract

Enteric-coated mycophenolate sodium (EC-MPS) (myfortic) is an advanced formulation delivering mycophenolic acid (MPA), designed to improve MPA-related upper gastrointestinal adverse events by delaying the release of MPA until the small intestine. A randomized, calcineurin inhibitor crossover, steady-state pharmacokinetic study in stable renal transplant patients receiving EC-MPS demonstrated increased MPA exposure of 19% higher, MPA C(max,ss) 19% lower and MPA C(min,ss) approximately twofold higher with tacrolimus, than cyclosporine microemulsion. No study drug-related adverse events were recorded, but mean blood glucose concentration was higher in patients receiving tacrolimus (p = 0.031). The dose changes in relation to MPA exposure in patients is dependent on the clinical situation and may not always be warranted. These observations should be taken into consideration when switching from one calcineurin inhibitor to another, but the final dosage should be based on both this pharmacokinetic data and the clinical situation.

Item Type: Article
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Date Deposited: 05 Oct 2012 23:45
Last Modified: 05 Oct 2012 23:45
URI: https://oak.novartis.com/id/eprint/8697

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