Exagamglogene autotemcel Side Effects

Applies to exagamglogene autotemcel: intravenous suspension.

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

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

Rash included dermatitis, erythematous rash, and maculopapular rash.^[Ref]

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]

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

Infusion-related reactions included abdominal pain, nausea, non-cardiac chest pain, pruritus, sinus tachycardia, and vomiting.^[Ref]

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]

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

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.

Medical Disclaimer