Note: This document contains side effect information about delandistrogene moxeparvovec. Some dosage forms listed on this page may not apply to the brand name Elevidys.

Applies to delandistrogene moxeparvovec: intravenous kit.

General

The most common adverse reactions occurring in greater than 5% of patients included vomiting, nausea, liver function test increased, pyrexia, and thrombocytopenia. Adverse reactions were typically seen within the first 2 weeks (nausea, vomiting, thrombocytopenia, pyrexia) or within the first 2 months (immune-mediated myositis, liver function test increased).^[Ref]

Cardiovascular

Frequency not reported: Myocarditis^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting, occurring as early as on the day of infusion (up to 65%), nausea (up to 40%)^[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (a transient, mild, asymptomatic decrease in platelet counts, 12%)^[Ref]

Hepatic

Very common (10% or more): Liver function test increased, including increased AST, ALT, GGT, GLDH, hepatic enzymes, transaminases, and blood bilirubin (up to 37%)

Frequency not reported: Acute serious liver injury^[Ref]

Immunologic

Very Common (10% or more): Elevated anti-AAVrh74 total binding antibodies titers (100%)^[Ref]

Musculoskeletal

Frequency not reported: Immune-mediated myositis^[Ref]

Other

Very common (10% or more): Pyrexia (up to 24%)