Elevidys

Risk of acute serious liver injury (esp. preexisting liver impairment, chronic hepatic condition, or acute hepatic viral infection). Monitor liver function (eg, clinical exam, GGT, total bilirubin) prior to infusion, weekly for the 1^st 3 months, then as clinically indicated until unremarkable results. Obtain platelets and troponin-I prior to infusion, weekly for the 1^st 2 weeks (platelets) and weekly for the 1^st month (troponin-I), then as clinically indicated. Increased risk of serious systemic immune response; delay infusion in those with concurrent infections until resolved. Risk of immune-mediated myositis (esp. deletions in the DMD gene in exons 1–17 and/or exons 59–71); if symptoms occur, consider additional immunomodulatory treatment (eg, calcineurin-inhibitor). Perform baseline anti-AAVrh74 antibody testing (Total Binding Antibody ELISA) prior to infusion. Elevated anti-AAVrh74 total binding antibody titers ≥1:400: not recommended. Consult a specialist if acute serious liver injury/liver failure is suspected or troponin elevations accompanied by signs/symptoms. Hepatic impairment or elevated GGT. Elderly. Pregnancy, nursing mothers: not applicable.