Elevidys Side Effects

Generic name: delandistrogene moxeparvovec

Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.

Note: This document provides detailed information about Elevidys.

Applies to delandistrogene moxeparvovec: intravenous suspension Side Effects associated with delandistrogene moxeparvovec. Some dosage forms listed on this page may not apply specifically to the brand name Elevidys.

Applies to delandistrogene moxeparvovec: intravenous suspension.

Precautions

Your doctor will check your child's progress closely while you are receiving this medicine to see if it is working properly and to decide if you or your child should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if your child has pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause muscle problems (eg, myositis). Check with your doctor right away if your child has difficulty swallowing, muscle pain or weakness, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if your child has chest pain or discomfort, fever and chills, fast heartbeat, or trouble breathing. These maybe symptoms of myocarditis (swelling of the heart).

Your child’s vaccines should be completed at least 4 weeks before starting steroid medicine. Ask your child’s doctor if you have any questions about this.

Serious side effects of Elevidys

Along with its needed effects, delandistrogene moxeparvovec (the active ingredient contained in Elevidys) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking delandistrogene moxeparvovec:

For healthcare professionals

Applies to delandistrogene moxeparvovec: intravenous kit.

General adverse events

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%)

See also:

Frequently asked questions

• How much does Elevidys cost?
• What are the new drugs for DMD (Duchenne muscular dystrophy)?

Further information

Elevidys side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer