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Therapeutic Drug Monitoring of Mycophenolate Mofetil in Transplantation

van Gelder, Teun MD, PhD*; Meur, Yann Le MD, PhD; Shaw, Leslie M. PhD; Oellerich, Michael MD, HonMD§; DeNofrio, David MD; Holt, Curtis PharmD; Holt, David W. PhD, DSc(Med); Kaplan, Bruce MD**; Kuypers, Dirk MD, PhD††; Meiser, Bruno MD‡‡; Toenshoff, Burkhard MD, PhD§§; Mamelok, Richard D. MD∥∥

doi: 10.1097/
Review Articles

A roundtable meeting to discuss the use of therapeutic drug monitoring (TDM) to guide immunosuppression with mycophenolate mofetil was held in New York in December 2004. Existing recommendations for the initial months after transplantation were updated. After ensuring adequate levels of mycophenolic acid (MPA, the active metabolite of mycophenolate mofetil) immediately after transplantation, optimal efficacy may require only a few dose adjustments, because intrapatient variability in exposure seems low. Recommendations based on current knowledge were made for posttransplantation sampling time points and for target MPA concentrations. Algorithms for estimating MPA exposure using limited sampling strategies were presented, and a new assay for MPA discussed. It was agreed that because of interpatient variability and the influence of concomitant immunosuppressants, TDM might help optimize outcomes, especially in patients at higher risk of rejection. The value of TDM in the general transplant population will be assessed from large, ongoing, randomized studies.

*Department of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands

Department of Nephrology, Central University Hospital Dupuytren, Limoges, France

Department of Pathology and Laboratory Medicine, University of Pennsylvania Medical Center, Philadelphia, PA

§Abteilung Klinische Chemie, Georg-August-Universität Göttingen, Germany

‡‡Department of Cardiac Surgery, University of Munich, Grosshadern Medical Center, Munich, Germany

§§University Children's Hospital, Heidelberg, Germany

Division of Cardiology, Tufts-New England Medical Center, Boston, MA

UCLA Department of Surgery, University of California, Los Angeles, CA

∥∥Mamelok Consulting, Palo Alto, CA

Analytical Unit, St George's University of London, London, UK

**Departments of Medicine and Pharmacology, University of Florida, Gainesville, FL

††Department of Nephrology and Renal Transplantation, University of Leuven, Belgium

This roundtable discussion meeting and preparation of this manuscript were supported by F Hoffmann-La Roche Ltd, Basel, Switzerland.

Reprints: Dr Teun van Gelder, Department of Hospital Pharmacy, Clinical Pharmacology Unit, Erasmus Medical Center, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands (e-mail:

Received for publication October 17, 2005; accepted November 22, 2005

All authors have previously acted as consultants or advisors for F Hoffmann-La Roche, among other pharmaceutical companies. Dr Holt is a consultant on the pharmacokinetics and bioanalytics of immunosuppressive drugs for Novartis, Roche, Wyeth, Astellas, Abbott Diagnostics, Microgenics, and Dade Behring.

© 2006 Lippincott Williams & Wilkins, Inc.