Safety evaluation of inotuzumab ozogamicin: a pharmacovigilance study based on the FAERS database

Int J Surg. 2025 May 12. doi: 10.1097/JS9.0000000000002435. Online ahead of print.

ABSTRACT

OBJECTIVE: Given inotuzumab ozogamicin (InO) relatively recent market introduction and ongoing new drug surveillance period, further research is needed on its adverse drug events (ADEs) in the real world.

METHODS: Retrieve and analyze ADE reports associated with InO from the FAERS database, covering the period from 2004Q1 to 2024Q3, and employ the reporting odds ratio (ROR) methodology to conduct signal detection for InO-related ADEs.

RESULTS: This study analyzed 1007 (2725 ADEs) patients, focusing on critical issues like veno-occlusive liver disease (VOD) (n = 97, ROR = 486.02), infections (n = 20, ROR = 3.27), and febrile neutropenia (n = 57, ROR = 20.43). Additionally, it also revealed some new ADEs, including sepsis (n = 35, ROR = 7.14), cytokine release syndrome (n = 22, ROR = 36.78), graft-versus-host disease (n = 20, ROR = 62.21), enterocolitis infectious (n = 3, ROR = 69.07), pneumonia fungal (n = 6, ROR = 30.76), and multiple organ dysfunction syndrome (n = 21, ROR = 10.65), among others. Consequently, it is imperative to exercise increased vigilance regarding these potential ADEs in the clinical administration of InO.

CONCLUSION: This study underscores the potential ADEs and associated risks with the clinical application of InO, with particular emphasis on the risks of VOD, infections, and febrile neutropenia. The implementation of a vigilant monitoring strategy is crucial for the early detection and timely management of these potential complications.

PMID:40359557 | DOI:10.1097/JS9.0000000000002435