Gozzo Lucia, Nardo Antonella, Brancati Serena, Judica Antongiulio, Duminuco Andrea, Maugeri Cinzia, Parisi Marina, Longo Laura, Vitale Daniela Cristina, Ruscica Rosy, Romano Giovanni Luca, Mauro Elisa, Fiumara Paolo Fabio, Palumbo Giuseppe Alberto Maria, Di Raimondo Francesco, Vetro Calogero, Drago Filippo
Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-S. Marco", 95123 Catania, Italy.
Haematology Unit, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-S. Marco", 95123 Catania, Italy.
Healthcare (Basel). 2023 May 18;11(10):1479. doi: 10.3390/healthcare11101479.
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.
鉴于吉瑞替尼在生存方面的优势以及良好的安全性，它已被批准作为单药疗法用于治疗复发或难治性急性髓系白血病（AML）且伴有FLT3突变的成人患者。肝胆疾病以及肌肉骨骼和结缔组织疾病是与吉瑞替尼相关的最常见不良反应，而最常见的严重不良反应是急性肾损伤。在产品特性摘要中，胃肠道（GI）事件被列为非常常见，尤其是腹泻、恶心和便秘。此外，在临床试验中已观察到吉瑞替尼会引发严重的胃肠道疾病，包括胃肠道出血、胃肠道穿孔和胃肠道梗阻。然而，与FLT3抑制剂的关联尚未得到证实。尽管如此，严重的胃肠道不良事件已被确认为上市后监测中需要监测的重要潜在风险。我们报告了3例在接受吉瑞替尼治疗AML的患者中观察到的严重自限性胃肠道事件，并对相关的上市后监测数据进行了分析。
