Delandistrogene Moxeparvovec-Rokl Interactions

FDA Black Box Warning

WARNING: 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 )]. WARNING: ACUTE SERIOUS LIVER INJURY AND ACUTE LIVER FAILURE See full prescribing information for complete boxed warning. Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred with ELEVIDYS. ( 5.1 ) Patients with preexisting liver impairment may be at higher risk. ( 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. ( 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. ( 2.1 ) Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acu