Fidanacogene elaparvovec Disease Interactions

There is limited information on the safety and effectiveness of fidanacogene elaparvovec in patients with HIV infection. Perform HIV testing prior to infusion, and do not administer this product to patients with either CD4+ cell count less than 200 mm3 or viral load equal to or greater than 20 copies/mL in case of serological evidence of HIV-1 or HIV-2 infection.

Fidanacogene elaparvovec has not been studied in patients with liver dysfunction. Furthermore, administration of this product can lead to liver transaminase elevations and hepatocyte injury. Patients should undergo a liver health assessment prior to treatment, which includes liver function tests, screening for active hepatitis B or C, and elastography and/or ultrasound to assess liver fibrosis. This product should not be administered to patients with current liver-related coagulopathy, hypoalbuminemia, persistent jaundice, or cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy, hepatic fibrosis, or active viral hepatitis.

Fidanacogene elaparvovec, a liver-targeting gene therapy, may carry the theoretical risk of hepatocellular carcinoma development. Patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) should be monitored with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following treatment.

Fidanacogene elaparvovec has not been studied in patients with renal dysfunction.