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Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co‐administered enteric‐coated mycophenolate sodium
Author(s) -
Kaplan Bruce,
MeierKriesche HerwigUlf,
Minnick Paula,
Bastien MarieClaude,
Sechaud Romain,
Yeh ChingMing,
Balez Sebastien,
Picard Franck,
Schmouder Robert
Publication year - 2005
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/j.1399-0012.2005.00387.x
Subject(s) - medicine , pharmacokinetics , calcineurin , mycophenolate , enteric coated , pharmacology , mycophenolic acid , enteric coating , sodium , randomized controlled trial , transplantation , dosage form , chemistry , organic chemistry
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.