Onasemnogene abeparvovec Disease Interactions

The use of onasemnogene abeparvovec-xioi can increase liver enzyme levels and cause acute serious liver injury. Close monitoring is recommended in patients with pre-existing liver impairment as they may be at higher risk. It is recommended to assess liver function of all patients by clinical examination and laboratory testing (e.g., hepatic aminotransferases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], total bilirubin, and prothrombin time) prior to infusion. Continue to monitor liver function for at least 3 months after infusion; weekly for the first month, and then every other week for the second and third months, until results are unremarkable. Administer systemic corticosteroid to all patients before and after onasemnogene abeparvovec-xioi infusion.

In clinical trials, transient increases in cardiac troponin-I levels (up to 0.176 µg/L) were observed following onasemnogene abeparvovec-xioi infusion. The clinical importance of these findings is not known; however, cardiac toxicity was observed in animal studies. Care should be exercised in patients at risk. It is recommended to monitor troponin-I before infusion and weekly for the first month, and then monthly for the second and third months until troponin-I level returns to baseline as appropriate.

Transient decreases in platelet counts, some of which met the criteria for thrombocytopenia, were observed at different time points after onasemnogene abeparvovec-xioi infusion. Care should be exercised in patients at risk. It is recommended to monitor platelet counts before the infusion and weekly for the first month; every other week for the second and third months until platelet counts return to baseline as appropriate.