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

Bruce Kaplan, Herwig Ulf Meier-Kriesche, Paula Minnick, Marie Claude Bastien, Romain Sechaud, Ching Ming Yeh, Sebastien Balez, Franck Picard, Robert Schmouder

    Research output: Contribution to journalArticlepeer-review

    43 Scopus citations

    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 Cmax,ss 19% lower and MPA Cmin,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.

    Original languageEnglish (US)
    Pages (from-to)551-558
    Number of pages8
    JournalClinical Transplantation
    Volume19
    Issue number4
    DOIs
    StatePublished - Aug 1 2005

    Keywords

    • Calcineurin inhibitors
    • Cyclosporine microemulsion
    • Enteric-coated mycophenolate sodium
    • Myfortic®
    • Pharmacokinetics
    • Tacrolimus

    ASJC Scopus subject areas

    • Transplantation

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