Casgevy Side Effects
Generic name: exagamglogene autotemcel
Note: This document contains side effect information about exagamglogene autotemcel. Some dosage forms listed on this page may not apply to the brand name Casgevy.
Applies to exagamglogene autotemcel: intravenous suspension.
Warning
Tell your doctor if you use other medicines or have other medical conditions or allergies.
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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severe headache;
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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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fever, mouth sores, skin sores, sore throat, cough; 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 exagamglogene autotemcel: intravenous suspension.
General
The most common grade 3 or 4 adverse reactions occurring in 25% or more patients were mucositis, febrile neutropenia, and decreased appetite. The most common grade 3 or 4 laboratory abnormalities occurring in 50% or more patients were neutropenia, thrombocytopenia, leukopenia, anemia, and lymphopenia.[Ref]
Cardiovascular
Common (1% to 10%): Tachycardia, hypotension, hot flush
Dermatologic
Very common (10% or more): Pruritus (up to 11%)
Common (1% to 10%): Petechiae, rash, dry skin, erythema, subcutaneous hematoma, skin abrasion, skin laceration
Frequency not reported: Alopecia, pigmentation disorder[Ref]
Rash included dermatitis, erythematous rash, and maculopapular rash.[Ref]
Endocrine
Common (1% to 10%): Amenorrhea, premature menopause, intermenstrual bleeding, dysmenorrhea, irregular menstruation[Ref]
Gastrointestinal
Very common (10% or more): Mucositis (up to 86%), abdominal pain/upper abdominal pain (up to 11%)
Common (1% to 10%): Mouth ulceration, gastritis, gingival bleeding, dyspepsia, dysphagia, gastrointestinal inflammation, esophagitis
Frequency not reported: Constipation, oropharyngeal pain[Ref]
Mucositis included mucosal inflammation, pharyngeal inflammation, and stomatitis.[Ref]
Hematologic
Very common (10% or more): Febrile neutropenia (up to 48%), neutropenia (up to 100%), thrombocytopenia (up to 100%), leukopenia (up to 98%), anemia (up to 84%), lymphopenia (up to 50%), decreased CD4 lymphocytes (up to 23%), prolonged activated partial thromboplastin time (up to 14%)
Common (1% to 10%): Splenomegaly[Ref]
Hepatic
Very common (10% or more): Cholelithiasis (up to 11%)
Common (1% to 10%): Veno-occlusive liver disease, hepatomegaly, hyperbilirubinemia, increased gamma-glutamyltransferase[Ref]
Immunologic
Common (1% to 10%): Hemophagocytic lymphohistiocytosis[Ref]
Metabolic
Very common (10% or more): Decreased appetite (up to 41%)
Common (1% to 10%): Hypocalcemia, hypoalbuminemia, hypomagnesemia
Frequency not reported: Hypokalemia, fluid retention, hypophosphatemia
Musculoskeletal
Very common (10% or more): Musculoskeletal pain (up to 14%)
Common (1% to 10%): Arthralgia[Ref]
Musculoskeletal pain included back pain, musculoskeletal chest pain, neck pain, non-cardiac pain, and pain in extremity.[Ref]
Nervous system
Very common (10% or more): Headache
Common (1% to 10%): Paresthesia, cerebellar hemorrhage, hydrocephalus, neuralgia[Ref]
Ocular
Common (1% to 10%): Blurry vision[Ref]
Other
Very common (10% or more): Infusion-related reactions (up to 14%)
Common (1% to 10%): Pyrexia, chills, increased weight, increased c-reactive protein, increased INR, delayed engraftment
Frequency not reported: Pain, sepsis, klebsiella sepsis[Ref]
Infusion-related reactions included abdominal pain, nausea, non-cardiac chest pain, pruritus, sinus tachycardia, and vomiting.[Ref]
Renal
Common (1% to 10%): Hematuria[Ref]
Respiratory
Common (1% to 10%): Acute respiratory distress syndrome, idiopathic pneumonia syndrome, epistaxis, cough, dyspnea
Frequency not reported: Pneumonia, COVID-19, respiratory failure[Ref]
More about Casgevy (exagamglogene autotemcel)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous uncategorized agents
- En español
Patient resources
Professional resources
Related treatment guides
References
1. Product Information. Casgevy (exagamglogene autotemcel). Vertex Pharmaceuticals. 2023.
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.