Delandistrogene Moxeparvovec Side Effects
Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.
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
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 side effects
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- pinpoint red spots on the skin
- unusual bleeding or bruising
Incidence not known
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:
Agamree
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Duvyzat
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Viltepso
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Amondys 45
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Elevidys
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Emflaza
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Vyondys 53
Vyondys 53 is used for Duchenne muscular dystrophy (DMD) in children and young adults with a ...
Exondys 51
Exondys 51 is used for Duchenne Muscular Dystrophy (DMD) in children and young adults with a ...
Vamorolone
Vamorolone (Agamree) is a novel corticosteroid used to treat Duchenne muscular dystrophy (DMD) ...
Givinostat
Givinostat (Duvyzat) is used to treat Duchenne muscular dystrophy (DMD) to delay symptoms and ...
References
1. (2023) "Product Information. Elevidys (10-10.4 kg) (delandistrogene moxeparvovec)." Sarepta Therapeutics
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Further information
Delandistrogene moxeparvovec 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.