An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics

In recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an i...

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Bibliographic Details
Main Authors: Roberto Bernardini, Gaia Toschi Vespasiani, Arianna Giannetti
Format: Article
Language:English
Published: MDPI AG 2022-04-01
Series:Medicina
Subjects:
Online Access:https://www.mdpi.com/1648-9144/58/5/625
Description
Summary:In recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an important public health issue, especially for children with rare conditions or with diseases not responsive to conventional treatments. The present paper is a narrative review of the literature of off-label drug use in children. The aim of our study is to summarize the main works dealing with the off-label use of biological drugs in paediatrics. Further studies analyzing their efficacy, safety, and cost–benefit ratios are needed to extend the use of biological therapies to the paediatric population.
ISSN:1010-660X
1648-9144