Delandistrogene moxeparvovec Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 4, 2024.

Applies to delandistrogene moxeparvovec: intravenous suspension.

Serious side effects

Along with its needed effects, delandistrogene moxeparvovec 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:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• pinpoint red spots on the skin
• unusual bleeding or bruising

Incidence not known

• Chest pain or discomfort
• cough
• dark urine
• fast heartbeat
• fever and chills
• loss of appetite
• muscle pain
• nausea or vomiting
• redness or swelling in the ear
• sore throat
• stomach pain, severe
• stuffy or runny nose
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

For Healthcare Professionals

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%)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer