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Annals of Hematology
Published in: Annals of Hematology 11/2023

Open Access 22-08-2023 | Acute Myeloid Leukemia | Original Article

Gilteritinib and the risk of intracranial hemorrhage: a case series of a possible, under-reported side effect

Authors: Salvatore Perrone, Stefano Imperatore, Giuseppe Sucato, Ermanno Notarianni, Andrea Corbingi, Costanza Andriola, Mariasanta Napolitano, Alessandro Pulsoni, Matteo Molica

Published in: Annals of Hematology | Issue 11/2023

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Abstract

Gilteritinib is currently approved for patients with relapsed/refractory AML with FLT3 mutations, based on the positive results of the pivotal ADMIRAL study. In ADMIRAL trial, no increased risk of bleeding was reported, but in the previous dose finding study, a single event of intracranial hemorrhage (ICH) was registered after exposure to subtherapeutic doses of gilteritinib. Here, we report the first case series on five ICHs diagnosed in patients with FLT3-mutated AML, occurred within the first month of exposure to gilteritinib. Our cohort included 24 patients treated in three Italian centers. Most of these ICH cases were non-severe and self-limiting, while one was fatal. This link with ICHs remains in any case uncertain for the presence of active AML. We further reported that an analysis of the post-marketing surveillance data (EudraVigilance) retrieved other 11 cases of ICHs present in the database after gilteritinib treatment. A causality assessment was performed according to the Dx3 method to evaluate the possibility that ICHs might be an actual side effect of gilteritinib. In conclusion, further research is needed to elucidate the potential role of gilteritinib in the pathogenesis of ICHs.
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Metadata
Title
Gilteritinib and the risk of intracranial hemorrhage: a case series of a possible, under-reported side effect
Authors
Salvatore Perrone
Stefano Imperatore
Giuseppe Sucato
Ermanno Notarianni
Andrea Corbingi
Costanza Andriola
Mariasanta Napolitano
Alessandro Pulsoni
Matteo Molica
Publication date
22-08-2023
Publisher
Springer Berlin Heidelberg
Published in
Annals of Hematology / Issue 11/2023
Print ISSN: 0939-5555
Electronic ISSN: 1432-0584
DOI
https://doi.org/10.1007/s00277-023-05392-2

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