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.