Acute Serious Liver Injury and Acute Liver Failure

• Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred with ELEVIDYS [see Warnings and Precautions (5.1)].
• Patients with preexisting liver impairment may be at higher risk [see Warnings and Precautions (5.1)].
• Prior to infusion, assess liver function by clinical examination and laboratory testing. Administer systemic corticosteroids before and after ELEVIDYS infusion. Continue to monitor liver function weekly for the first 3 months after infusion and continue until results are unremarkable [see Dosage and Administration (2.1, 2.2, 2.4)].
• Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by the healthcare provider, for at least 2 months following ELEVIDYS infusion [see Dosage and Administration (2.1)].
• Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected [see Dosage and Administration (2.2), Warnings and Precautions (5.1)].