Besponsa and Liver dysfunction

Hepatotoxicity, including severe, life-threatening, and sometimes fatal hepatic veno-occlusive disease (VOD) may occur during or following treatment with inotuzumab ozogamicin. The risk of VOD is greater in patients who underwent hematopoietic stem cell transplant (HSCT) after inotuzumab ozogamicin treatment, total bilirubin level greater than or equal to the ULN before HSCT, ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of treatment cycles. Patients who have experienced prior VOD or have serious ongoing hepatic liver disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis) are at an increased risk for worsening of liver disease, including developing VOD, following treatment with inotuzumab ozogamicin. Monitor closely for signs and symptoms of VOD; these may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. It is recommended to monitor liver tests in all patients, including ALT, AST, total bilirubin, and alkaline phosphatase, before and following each dose of inotuzumab ozogamicin. Elevations of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of treatment.