Atidarsagene autotemcel Side Effects
Applies to atidarsagene autotemcel: intravenous suspension.
Warning
You may get infections or bleed more easily. Call your doctor if you have unusual bleeding or signs of infection (fever, cough, skin sores, painful urination).
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Tell your medical caregivers right away if you have:
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unusual bruising or bleeding;
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sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;
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problems with thinking or memory, muscle movement problems, weakness, vomiting, trouble swallowing; or
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chills, fever, infections.
Common side effects may include:
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fever, mouth sores, skin sores, sore throat, cough;
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swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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blisters or ulcers in your mouth, red or swollen gums, trouble swallowing, stomach upset;
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cold symptoms such as stuffy nose, sneezing, sore throat;
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rash; or
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abnormal lab results.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to atidarsagene autotemcel: intravenous suspension.
General
The most common adverse reactions occurring in at least 10% of all pediatric patients within the first year of treatment included febrile neutropenia, stomatitis, elevated D-dimer, respiratory tract infections, rash, device-related infections, other viral infections, neutropenia, elevated liver enzymes, pyrexia, gastroenteritis, and hepatomegaly. The reported adverse effects include events potentially related to busulfan-based myeloablative conditioning.[Ref]
Cardiovascular
Frequency not reported: Veno-occlusive disease
Dermatologic
Very common (10% or more): Rash (33%)
Rash also includes dermatitis, bullous dermatitis, erythematous rash, drug eruption, and maculopapular rash.
Gastrointestinal
Very common (10% or more): Stomatitis (77%), gastroenteritis (21%)
Gastroenteritis also includes enteritis, Aeromonas gastroenteritis, and rotavirus gastroenteritis.
Hematologic
Very common (10% or more): Febrile neutropenia (85%), elevated levels of D-dimer greater than 4.2 nmol/L (67%), neutropenia following conditioning (28%)
Common (1% to 10%): Anemia
Frequency not reported: Delayed platelet engraftment
Hepatic
Very common (10% or more): Hepatomegaly (18%), elevated liver enzymes (23%)
Frequency not reported: Elevated liver enzymes (AST/ALT)
Immunologic
Frequency not reported: Anti-arylsulfatase A antibodies
Nervous system
Frequency not reported: Encephalitis, cerebral infarction secondary to a thrombotic event
Other
Very common (10% or more): Pyrexia (21%), device-related infections (31%), other viral infections (28%)
Device-related infections also includes events of bacterial sepsis, catheter-site cellulitis, catheter-site infection, sepsis, and vascular-device infection.
Other viral infections also includes adenovirus infection, cytomegalovirus infection, cytomegalovirus test positive, cytomegalovirus viremia, enterovirus infection, hand-foot-and-mouth disease, herpes zoster, positive SARS-CoV-2 test, and viral infection (excluding rotavirus gastroenteritis).
Respiratory
Very common (10% or more): Respiratory infections (54%)
Respiratory infections also includes bronchitis, nasopharyngitis, pharyngitis, pneumonia, rhinitis, tonsillitis, upper respiratory fungal infection, and upper respiratory tract infection.
More about atidarsagene autotemcel
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- Dosage information
- During pregnancy
- Drug class: miscellaneous uncategorized agents
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References
1. (2024) "Product Information. Lenmeldy (atidarsagene autotemcel)." Orchard Therapeutics
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.