Etranacogene dezaparvovec Disease Interactions

Therapy with etranacogene dezaparvovec may increase the risk of hepatocellular carcinoma development. Patients with preexisting risk factors for hepatocellular cancer such as cirrhosis, advanced hepatic fibrosis, hepatitis B or C, non-alcoholic fatty liver disease, alcoholism, non-alcoholic steatohepatitis, and advanced age should be monitored annually with a liver ultrasound and alpha-fetoprotein testing during 5 years following administration. The safety and efficacy of this drug in patients with severe hepatic impairment has not been studied.

The safety and efficacy of etranacogene dezaparvovec in patients with severe renal impairment and end-stage renal disease have not been studied. Caution is advised.