Casgevy Side Effects

Generic name: exagamglogene autotemcel

Note: This document provides detailed information about Casgevy Side Effects associated with exagamglogene autotemcel. Some dosage forms listed on this page may not apply specifically to the brand name Casgevy.

Applies to exagamglogene 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.

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:

• chills, fever, infections;

• severe headache;

• unusual bruising or bleeding; or

• nosebleeds, bleeding gums, blood in your urine or vomit, bloody or tarry stools, or coughing up blood.

Common side effects may include:

• fever, mouth sores, skin sores, sore throat, cough; or

• 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 adverse events

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^[Ref]

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^[Ref]

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]

Further information

Casgevy 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.

Medical Disclaimer