Lovotibeglogene Autotemcel Side Effects
Applies to lovotibeglogene autotemcel: intravenous suspension.
Important warnings
This medicine can cause some serious health issues
Tell your doctor if you use other medicines or have other medical conditions or allergies.
Using lovotibeglogene autotemcel may increase your risk of developing blood cancer. Ask your doctor about your individual risk.
You may get infections or bleed more easily.
Call your doctor if you have severe headache, 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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chills, fever, infections;
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swollen glands;
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severe headache;
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stomach or back pain;
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tiredness;
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unusual bruising or bleeding; or
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nosebleeds, bleeding gums, blood in your urine or vomit, bloody or tarry stools, or coughing up blood.
Common side effects may include:
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blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
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fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
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easy bruising, unusual bleeding, purple or red spots under your skin.
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 lovotibeglogene autotemcel: intravenous suspension.
General adverse events
The most commonly reported grade 3 or greater adverse reactions were anemia, febrile neutropenia, leukopenia, neutropenia, stomatitis, and thrombocytopenia.[Ref]
Gastrointestinal
- Very common (10% or more): Stomatitis (71%)
- Common (1% to 10%): Nausea
Hematologic
- Very common (10% or more): Thrombocytopenia (69%), neutropenia (60%), febrile neutropenia (44%), anemia (33%), leukopenia (33%), sickle cell anemia with crisis (16%)
- Frequency not reported: Delayed platelet engraftment, neutrophil engraftment failure
Mobilization and apheresis triggered serious adverse effects of sickle cell crisis in 14% of patients. Sickle cell anemia with crisis included events prior to Month 6 and non-adjudicated occurrences.
Hypersensitivity
- Frequency not reported: Hypersensitivity reactions
Metabolic
- Very common (10% or more): Decreased appetite (11%)
Oncologic
- Frequency not reported: Hematologic malignancy, insertional oncogenesis
Other
- Common (1% to 10%): Bacteremia, pyrexia
- Frequency not reported: Infusion-related reactions
Infusion-related reaction events included hot flush and decreased diastolic blood pressure.
Respiratory
- Very common (10% or more): Pharyngeal inflammation (11%)
Hepatic
- Very common (10% or more): Increased AST (18%), increased ALT (13%), increased gamma-glutamyl transferase (13%)
- Common (1% to 10%): Increased blood bilirubin
References
1. (2023) "Product Information. Lyfgenia (lovotibeglogene autotemcel)." bluebird bio
More about lovotibeglogene autotemcel
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Further information
Lovotibeglogene autotemcel 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.