Mycophenolate mofetil pharmacokinetic monitoring in pediatric kidney transplant recipients

L. Ghio, M. Ferraresso, S. M. Viganò, F. Ginevri, F. Perfumo, B. Gianoglio, L. Murer, G. Zacchello, L. Dello Strologo, M. Cardillo, S. Tirelli, U. Valente, A. Edefonti

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Abstract

This open-label, longitudinal, long-term study of de novo pediatric renal transplant recipients was designed to investigate the pharmacokinetics (PK) of mycophenolic acid (MPA) and its possible interaction with cyclosporine (CsA). Thirty-four children on an immunosuppressive regimen of CsA, prednisone, and mycophenolate mofetil (MMF, 300-400 mg/m 2 twice daily) were investigated at 6, 30, 180, and 360 days after transplantation. Considerable interindividual variability in the areas under the concentration curve (AUC (0-12)) of MPA was observed during the follow-up, although the dose of MMF remained the same over the same time. Predose levels (C0) increased significantly during the first 6 months after transplantation: C0 at 6 and 180 days after transplantation was 0.8 ± 0.6 and 1.9 ± 1.1 μg/mL (P <.0001). A significant time-dependent increase in the AUC of MPA was also observed during the first 6 posttransplant months: AUC (0-12) at 6 and 180 days after transplantation was 23.3 ± 10.8 and 40 ± 11.6 mg*h/L (P = .003). MPA concentrations 3 and 4 hours after MMF intake were the individual time points that best correlated with the full MPA AUC (r = 0.8 and 0.79; P <.001). The abbreviated MPA AUC (0-4 hours) correlated reasonably with the full AUC (r = 0.87; P <.001). Finally, a significant reduction in CsA dose during the first 6 posttransplant months (P <.001) matched the significant increases in both MPA C0 and full MPA AUC, thus demonstrating the interaction of the 2 immunosuppressive drugs. These observations suggest the need for therapeutic drug monitoring when adjusting the dose of MMF in children.

Original languageEnglish
Pages (from-to)856-858
Number of pages3
JournalTransplantation Proceedings
Volume37
Issue number2
DOIs
Publication statusPublished - Mar 2005

ASJC Scopus subject areas

  • Surgery
  • Transplantation

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