Mycophenolate mofetil in islet cell transplant: Variable pharmacokinetics but good correlation between total and unbound concentrations

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Abstract

The authors investigated the pharmacokinetics of mycophenolic acid over 1 year in 8 Caucasian women undergoing islet cell transplantation. Total mycophenolic acid AUC0-12 mcg•h/mL before day 60 was 62.1-67.8, declining to 33.6-64.7 thereafter (P = .61). Median total trough concentrations were 1.16-2.90 mcg/mL. Unbound AUC0-12 was 412-673 ng•h/mL and did not change over time (P = .30). Median percent unbound mycophenolic acid was 0.95% of total concentrations. Individual unbound and total mycophenolic acid concentrations were highly correlated (r2 = 0.94). Total mycophenolic acid trough concentration and total AUC0-12 were modestly correlated (r2 = 0.65). Intra- and interpatient variability of systemic mycophenolic acid exposure was high. Six patients required dose reductions prior to day 60 due to adverse effects. All subjects achieved insulin independence; 3 later lost graft function. The trend toward higher exposure in the early periods followed by dose reductions suggests that lower initial doses and therapeutic drug monitoring may be necessary.

Original languageEnglish (US)
Pages (from-to)901-909
Number of pages9
JournalJournal of Clinical Pharmacology
Volume45
Issue number8
DOIs
StatePublished - Aug 2005

Keywords

  • Mycophenolate mofetil
  • Mycophenolic acid
  • Mycophenolic acid glucuronide
  • Pharmacokinetics

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