Personalized Therapy for Mycophenolate: Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology
Therapeutic Drug Monitoring, vol. 43, pp. 150–200
Abstract
ABSTRACT: When mycophenolic acid (MPA) was originally marketed for immunosuppressive therapy, fixed doses were recommended by the manufacturer. Awareness of the potential for a more personalized dosing has led to development of methods to estimate MPA area under the curve based on the measurement of drug concentrations in only a few samples. This approach is feasible in the clinical routine and has proven successful in terms of correlation with outcome. However, the search for superior correlates has continued, and numerous studies in search of biomarkers that could better predict the perfect dosage for the individual patient have been published. As it was considered timely for an updated and comprehensive presentation of consensus on the status for personalized treatment with MPA, this report was prepared following an initiative from members of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT). Topics included are the criteria for analytics, methods to estimate exposure including pharmacometrics, the potential influence of pharmacogenetics, development of biomarkers, and the practical aspects of implementation of target concentration intervention. For selected topics with sufficient evidence, such as the application of limited sampling strategies for MPA area under the curve, graded recommendations on target ranges are presented. To provide a comprehensive review, this report also includes updates on the status of potential biomarkers including those which may be promising but with a low level of evidence. In view of the fact that there are very few new immunosuppressive drugs under development for the transplant field, it is likely that MPA will continue to be prescribed on a large scale in the upcoming years. Discontinuation of therapy due to adverse effects is relatively common, increasing the risk for late rejections, which may contribute to graft loss. Therefore, the continued search for innovative methods to better personalize MPA dosage is warranted.
Authors 36
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Stein Bergan corresponding
Oslo University Hospital · University of Oslo
Affiliation as printed
Department of Pharmacology, Oslo University Hospital and Department of Pharmacy, University of Oslo, Oslo, Norway;
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Hospital Clínic de Barcelona · Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · Consorci Institut D'Investigacions Biomediques August Pi I Sunyer · Universitat de Barcelona
Affiliation as printed
Pharmacology and Toxicology Laboratory, Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic of Barcelona, University of Barcelona, IDIBAPS, CIBERehd, Spain;
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Affiliation as printed
Department of Internal Medicine, Division of Nephrology and Transplantation, Erasmus MC, University Medical Center Rotterdam, The Netherlands;
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University of Utah · ARUP Laboratories (United States)
Affiliation as printed
Department of Pathology, University of Utah Health Sciences Center and ARUP Laboratories, Salt Lake City, Utah;
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Affiliation as printed
Department of Drug Chemistry, Faculty of Pharmacy, Medical University of Warsaw, Warszawa, Poland;
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Inserm · Centre Hospitalier Universitaire de Limoges · Pharmacologie & Transplantation · Université de Limoges
Affiliation as printed
INSERM, Université de Limoges, Department of Pharmacology and Toxicology, CHU de Limoges, U1248 IPPRITT, Limoges, France;
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Policlinico San Matteo Fondazione
Affiliation as printed
Clinical and Experimental Pharmacokinetics Lab, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;
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Hospital Central de las Fuerzas Armadas
Affiliation as printed
National Center for Liver Tansplantation and Liver Diseases, Army Forces Hospital, Montevideo, Uruguay;
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Post Graduate Institute of Medical Education and Research
Affiliation as printed
Department of Pharmacology, PGIMER, Chandigarh, India;
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Affiliation as printed
Department of Drug Chemistry, Faculty of Pharmacy, Medical University of Warsaw, Warszawa, Poland;
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Affiliation as printed
Risch Laboratory Group, Buchs, SG, Switzerland;
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Affiliation as printed
Synlab TDM Competence Center, Synlab MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, Germany;
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands;
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands;
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Affiliation as printed
Department of Pharmaceutical Sciences, School of Pharmacy and Department of Pathology, Starzl Transplantation Institute, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania;
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Affiliation as printed
Synlab TDM Competence Center, Synlab MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, Germany;
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Inserm · Centre Hospitalier Universitaire de Limoges · Pharmacologie & Transplantation · Université de Limoges
Affiliation as printed
INSERM, Université de Limoges, Department of Pharmacology and Toxicology, CHU de Limoges, U1248 IPPRITT, Limoges, France;
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands;
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Affiliation as printed
Department of Cardiac- and Vascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany;
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Charité - Universitätsmedizin Berlin
Affiliation as printed
Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany;
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Affiliation as printed
Department of Cardiac Surgery, Heart Center, HELIOS Clinic, University Hospital Leipzig, Leipzig, Germany;
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Affiliation as printed
Integrated PharmacoMetrics, PharmacoGenomics and PharmacoKinetics (PMGK) Research Group, Louvain Drug Research Institute (LDRI), Université Catholique de Louvain (UCLouvain), Brussels, Belgium;
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Cliniques Universitaires Saint-Luc · UCLouvain
Affiliation as printed
Louvain Centre for Toxicology and Applied Pharmacology (LTAP), Institut de Recherche Expérimentale et Clinique, UCLouvain and Department of Clinical Chemistry, Cliniques Universitaires Saint-Luc, Brussels, Belgium;
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International University of Health and Welfare
Affiliation as printed
Department of Pharmacy, International University of Health and Welfare Narita Hospital, Chiba, Japan;
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Hospital Clínic de Barcelona · Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · Consorci Institut D'Investigacions Biomediques August Pi I Sunyer · Universitat de Barcelona
Affiliation as printed
Pharmacology and Toxicology Laboratory, Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic of Barcelona, University of Barcelona, IDIBAPS, CIBERehd, Spain;
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Cincinnati Children's Hospital Medical Center · University of Cincinnati
Affiliation as printed
Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio;
Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands;
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Universitätsmedizin Göttingen · University of Göttingen
Affiliation as printed
Department of Clinical Pharmacology, University Medical Center Göttingen, Georg-August-University Göttingen, Göttingen, Germany;
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Affiliation as printed
Risch Laboratory Group, Buchs, SG, Switzerland;
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University Hospital Heidelberg
Affiliation as printed
Department of Pediatrics I, University Children's Hospital, Heidelberg, Germany;
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Affiliation as printed
Department of Clinical Chemistry, Erasmus MC University Medical Center, Rotterdam, The Netherlands;
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Oslo University Hospital · University of Oslo
Affiliation as printed
Department of Pharmacology, Oslo University Hospital and Department of Pharmacy, University of Oslo, Oslo, Norway;
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International University of Health and Welfare
Affiliation as printed
Department of Pharmacy, International University of Health and Welfare Narita Hospital, Chiba, Japan;
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Cliniques Universitaires Saint-Luc · UCLouvain
Affiliation as printed
Clinical Chemistry Department, Cliniques Universitaires St Luc, Université Catholique de Louvain, LTAP, Brussels, Belgium;
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Oslo University Hospital · University of Oslo
Affiliation as printed
Department of Transplantation Medicine, Oslo University Hospital-Rikshospitalet and Department of Pharmacy, University of Oslo, Oslo, Norway; and
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Affiliation as printed
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota
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