Afamitresgene Autoleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 10, 2024.

Applies to afamitresgene autoleucel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

Tell your medical caregivers if you have symptoms of a serious side effect such as fever, chills, trouble breathing, vomiting, or severe tiredness.

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 if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tell your caregivers or seek emergency medical attention if you have signs of life-threatening neurological problems: problems with speech, problems with thinking or memory, confusion, or a seizure.

Call your doctor at once if you have:

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite;

• easy bruising or bleeding, unusual weakness; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• swelling in any part of your body;

• chest pain;

• fast heart rate;

• stomach or back pain;

• trouble breathing;

• low blood cell counts;

• nausea, vomiting, constipation, or diarrhea;

• loss of appetite;

• low blood pressure; or

• fever, chills, tiredness, or other signs of infection.

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 afamitresgene autoleucel: intravenous suspension.

General adverse events

The most frequently reported side effects included abdominal pain, back pain, constipation, cytokine release syndrome, decreased appetite, diarrhea, dyspnea, edema, fatigue, hypotension, infections, nausea, non-cardiac chest pain, pyrexia, tachycardia, and vomiting.

The most frequently reported serious side effects included cytokine release syndrome and pleural effusion.^[Ref]

Cardiovascular

• Very common (10% or more): Edema (21%), hypotension (21%), sinus tachycardia or tachycardia (21%), hypertension (16%)^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (14%)^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (66%), vomiting (36%), constipation (32%), abdominal pain (25%), diarrhea (21%)^[Ref]

Hematologic

• Very common (10% or more): Decreased lymphocyte count (98%), decreased neutrophil count (96%), decreased white blood cell (96%), decreased red blood cell (96%), decreased platelet count (82%)^[Ref]

Hepatic

• Very common (10% or more): Increased alanine aminotransferase (46%)^[Ref]

Immunologic

• Very common (10% or more): Cytokine release syndrome (75%)^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (23%)^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (21%), pain in extremity (14%)^[Ref]

Nervous system

• Very common (10% or more): Headache (18%), dizziness (11%)
• Common (1% to 10%): Immune effector cell-associated neurotoxicity syndrome^[Ref]

Other

• Very common (10% or more): Fatigue (34%), infection (32%), pyrexia (32%), chills (16%), chest pain (14%), decreased weight (11%)^[Ref]

Psychiatric

• Very common (10% or more): Asthenia (17%)^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (25%), non-cardiac chest pain (23%), cough (18%)^[Ref]

Further information

Afamitresgene autoleucel 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