Brand names: Zolgensma
FDA Black Box Warning
WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE Cases of acute liver failure with fatal outcomes have been reported. Acute serious liver injury and elevated aminotransferases can also occur with ZOLGENSMA [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 of all patients by clinical examination and laboratory testing. Administer systemic corticosteroid to all patients before and after ZOLGENSMA infusion. Continue to monitor liver function for at least 3 months after infusion, and at other times as clinically indicated [see Dosage and Administration ( 2.1 , 2.3 )]. WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE See full prescribing information for complete boxed warning. Cases of acute liver failure with fatal outcomes have been reported. Acute serious liver injury and elevated aminotransferases can also occur with ZOLGENSMA. ( 5.1 ) Patients with preexisting liver impairment may be at higher risk. ( 5.1 ) Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing. Administer systemic corticosteroid to all patients before and after ZOLGENSMA infusion. Continue to monitor liver function for at least 3 months after infusion, and at other times as clinically indicated. ( 2.1 , 2.3 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no available data regarding ZOLGENSMA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ZOLGENSMA. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
1 interaction on record
Adjust vaccination schedule to accommodate concomitant corticosteroid administration prior to and following ZOLGENSMA infusion. Substantially immunosuppressive steroid doses (≥2 weeks of 20 mg or 2 mg/kg prednisone or equivalent) contraindicate certain live vaccines.
Source: NLP:onasemnogene abeparvovec-xioi