title: [Not Available].
abstract: Everolimus has proven efficacy for prevention of rejection in adult de novo renal and cardiac transplant recipient in combination with ciclosporine and corticosteroids. Therapeutic drug monitoring (TDM) with target trough concentration (C0) value from 3 to 8 μg/L has been proposed. Through a systematic review of the literature, this work explored a level of recommendation for this TDM. Everolimus exhibits both wide interindividual pharmacokinetic variability and poor relationship between dose and exposure. A good relationship has been reported between C0 values and global exposure to the drug (i.e. AUC). Although C0 > 3 μg/L has been associated with a decreased incidence of rejection, the upper limit of 8 μg/L has never been formally validated. No clinical trial testing other exposure indices or comparing efficacy and/or toxicity of everolimus therapy with and without TDM has been published so far. Consequently the level of recommendation for everolimus monitoring is "recommended".
authors.affiliation: Laboratoire de Pharmacologie et Toxicologie, CHU Dijon, France. Electronic address: francoise.goirand@u-bourgogne.fr.
authors.forename: Françoise
authors.initials: F
authors.lastname: Goirand
authors.affiliation: Laboratoire de Pharmacologie et Toxicologie, Hôpital Jean Minjoz, Besançon, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Royer
authors.affiliation: Laboratoire de Pharmacologie et Toxicologie, AP-HP, CHU Henri Mondor, Créteil, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Hulin
authors.affiliation: Laboratoire de Pharmacologie et Toxicologie, CHU Limoges, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Saint-Marcoux
keywords: everolimus; level of evidence; monitoring; niveau de preuve; suivi thérapeutique et pharmacologique; therapeutic drug; évérolimus