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Clin Transplant ; 19(4): 551-8, 2005 Aug.
Article in English | MEDLINE | ID: mdl-16008604

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.


Subject(s)
Calcineurin Inhibitors , Enzyme Inhibitors/administration & dosage , Enzyme Inhibitors/pharmacokinetics , Kidney Transplantation , Mycophenolic Acid/administration & dosage , Mycophenolic Acid/pharmacokinetics , Adult , Aged , Blood Glucose/analysis , Cross-Over Studies , Cyclosporine/pharmacokinetics , Emulsions , Female , Humans , Male , Middle Aged , Sodium/administration & dosage , Tablets, Enteric-Coated , Tacrolimus/pharmacokinetics
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