Elevidys Side Effects

Generic name: delandistrogene moxeparvovec

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

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 suspension.

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:

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]