Everolimus Personalized Therapy: Second Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology
Therapeutic Drug Monitoring, vol. 47, pp. 4–31
Abstract
ABSTRACT: The Immunosuppressive Drugs Scientific Committee of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology established the second consensus report to guide therapeutic drug monitoring (TDM) of everolimus (EVR) and its optimal use in clinical practice 7 years after the first version was published in 2016. This version provides information focused on new developments that have arisen in the last 7 years. For the general aspects of the pharmacology and TDM of EVR that have retained their relevance, readers can refer to the 2016 document. This edition includes new evidence from the literature, focusing on the topics updated during the last 7 years, including indirect pharmacological effects of EVR on the mammalian target of rapamycin complex 2 with the major mechanism of direct inhibition of the mammalian target of rapamycin complex 1. In addition, various concepts and technical options to monitor EVR concentrations, improve analytical performance, and increase the number of options available for immunochemical analytical methods have been included. Only limited new pharmacogenetic information regarding EVR has emerged; however, pharmacometrics and model-informed precision dosing have been constructed using physiological parameters as covariates, including pharmacogenetic information. In clinical settings, EVR is combined with a decreased dose of calcineurin inhibitors, such as tacrolimus and cyclosporine, instead of mycophenolic acid. The literature and recommendations for specific organ transplantations, such as that of the kidneys, liver, heart, and lungs, as well as for oncology and pediatrics have been updated. EVR TDM for pancreatic and islet transplantation has been added to this edition. The pharmacodynamic monitoring of EVR in organ transplantation has also been updated. These updates and additions, along with the previous version of this consensus document, will be helpful to clinicians and researchers treating patients receiving EVR.
Authors 30
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Satohiro Masuda corresponding
Affiliation as printed
Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Himeji Dokkyo University, Himeji, Japan;
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Affiliation as printed
Department of Cardiac and Vascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany;
Department of Cardiac- and Vascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany;
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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, Norway;
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Maria Shipkova corresponding
Affiliation as printed
Bioscientia Healthcare, Ingelheim, 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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Eberhard Wieland corresponding
Affiliation as printed
Bioscientia Healthcare, Ingelheim, Germany;
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Affiliation as printed
Chronix Biomedical GmbH, Göttingen, Germany;
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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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Brenda C. M. de Winter corresponding
Affiliation as printed
Department of Hospital Pharmacy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands;
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Affiliation as printed
Laboratory Management Research Laboratory, Cardiac Surgery Clinic, Heart Center Leipzig GmbH, University Hospital, Leipzig, Germany;
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Affiliation as printed
Integrated Pharmacometrics, Pharmacogenetic and Pharmacokinetics Research Group (PMGK) Louvain Drug for Research Institute (LDRI), Catholic University of Louvain, (UCLouvain), Brussels, Belgium;
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Affiliation as printed
Department of Organ Transplant Surgery; Fujita Health University School of Medicine, Toyoake Aichi, Japan;
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University of Utah · ARUP Laboratories (United States)
Affiliation as printed
University of Utah Health Sciences Center and ARUP Laboratories, Salt Lake City, Utah
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Affiliation as printed
Department of Drug Chemistry, Pharmaceutical and Biomedical Analysis, Faculty of Pharmacy, Medical University of Warsaw, Warsaw, Poland;
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Roland Lawson corresponding
Inserm · Pharmacologie & Transplantation · Université de Limoges
Affiliation as printed
University of Limoges, Inserm U1248, Pharmacology & Transplantation, Limoges, France;
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Bellvitge University Hospital · Institut d'Investigació Biomédica de Bellvitge
Affiliation as printed
Nephrology Department, Hospital Universitari de Bellvitge-Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain;
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Pierre P. Marquet corresponding
Inserm · Centre Hospitalier Universitaire de Limoges · Pharmacologie & Transplantation · Université de Limoges
Affiliation as printed
Department of Pharmacology, Toxicology and Pharmacovigilance, CHU de Limoges, France;
University of Limoges, Inserm U1248, Pharmacology & Transplantation, Limoges, France;
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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 · University of Cincinnati Medical Center
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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Hospital Central de las Fuerzas Armadas
Affiliation as printed
National Center for Liver Transplantation and Liver Diseases, Army Forces Hospital, Montevideo, Uruguay;
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Michael Oellerich corresponding
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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Post Graduate Institute of Medical Education and Research
Affiliation as printed
Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India;
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Affiliation as printed
Department of Drug Chemistry, Pharmaceutical and Biomedical Analysis, Faculty of Pharmacy, Medical University of Warsaw, Warsaw, Poland;
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Affiliation as printed
Labordiagnostic St. Gallen West AG, St. Gallen, Switzerland;
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Affiliation as printed
Department of Clinical Chemistry, Erasmus MC University Medical Center, Rotterdam, 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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Philip D. Walson corresponding
Universitätsmedizin Göttingen · University of Göttingen
Affiliation as printed
University Medical School, Göttingen, Germany;
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Centre Hospitalier Universitaire de Limoges
Affiliation as printed
Department of Pharmacology, Toxicology and Pharmacovigilance, CHU de Limoges, Limoges, France; and
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Affiliation as printed
Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota
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