Corticosteroid regimen is required before ELEVIDYS administration. Patients should complete vaccinations at least 4 weeks prior to corticosteroid initiation due to immunosuppressive effects.
Source: NLP:delandistrogene moxeparvovec-rokl
Delandistrogene Moxeparvovec-Rokl Interactions
Brand names: Elevidys
Route: Intravenous
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
Contraindications
4 CONTRAINDICATIONS ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9, including a deletion of any portion or the entirety of these exons, in the DMD gene [see Warnings and Precautions ( 5.5 )] . ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9, including a deletion of any portion or the entirety of these exons, in the DMD gene. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary ELEVIDYS is not intended for use in pregnant women. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
1 interaction on record