학술논문
Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data
Document Type
article
Author
Lucia Gozzo; Antonella Nardo; Serena Brancati; Antongiulio Judica; Andrea Duminuco; Cinzia Maugeri; Marina Parisi; Laura Longo; Daniela Cristina Vitale; Rosy Ruscica; Giovanni Luca Romano; Elisa Mauro; Paolo Fabio Fiumara; Giuseppe Alberto Maria Palumbo; Francesco Di Raimondo; Calogero Vetro; Filippo Drago
Source
Healthcare, Vol 11, Iss 10, p 1479 (2023)
Subject
Language
English
ISSN
2227-9032
Abstract
Gilteritinib has been approved as monotherapy in adults with acute myeloid leukemia (AML) FLT3 mutated with relapsed or refractory disease, in light of its advantages in terms of survival and the favorable safety profile. Hepatobiliary disorders and musculoskeletal and connective tissue disorders represent the most frequent adverse reactions associated with gilteritinib, whereas the most frequent serious adverse reaction is acute kidney injury. In the summary of product characteristics, gastrointestinal (GI) events are indicated as very common, in particular diarrhea, nausea and stypsis. Furthermore, serious GI disorders have been observed with gilteritinib in clinical trials, including GI hemorrhage, GI perforation and GI obstruction. However, the association with the FLT3 inhibitor has not been confirmed. Nevertheless, serious GI AEs have been recognized as an important potential risk to be monitored in postmarketing surveillance. We present three cases of serious self-limiting GI events observed in patients on gilteritinib treatment for AML, and an analysis of relevant available postmarketing surveillance data.