Skip to Content

Axicabtagene ciloleucel Side Effects

For the Consumer

Applies to axicabtagene ciloleucel: 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.

A serious side effect of axicabtagene ciloleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed, or feeling very weak or tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

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

Also call your doctor at once if you have:

  • headaches, dizziness;

  • tremors, anxiety, trouble sleeping;

  • unusual thoughts or behavior;

  • trouble speaking or understanding what is said to you; or

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

Common side effects may include:

  • nausea, diarrhea;

  • low blood cells;

  • confusion; or

  • fast heartbeats.

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 axicabtagene ciloleucel: intravenous suspension

General

-The most common adverse reactions (reported incidence of 30% or greater) include lymphopenia, leukopenia, cytokine release syndrome, neutropenia, fever, anemia, thrombocytopenia, encephalopathy, hypotension, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, nausea, hypoxia, tremor, and cough.

-In the event of a manufacturing failure (1% in clinical trials), a second manufacturing of this drug may be attempted; while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period.[Ref]

Hematologic

-The reported hematologic adverse reactions are either Grade 3 or 4.
-Due to the on-target effect of this drug, a period of B-cell aplasia is expected.[Ref]

Very common (10% or more): Lymphopenia (100%), leukopenia (96%), neutropenia (93%), anemia (66%), thrombocytopenia (58%), febrile neutropenia (36%)
Common (1% to 10%): Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)[Ref]

Other

Very common (10% or more): Fever (86%), fatigue (46%), chills (40%), infections-pathogen unspecified (26%), edema (19%), viral infections (16%), bacterial infections (13%)
Common (1% to 10%): Fungal infections[Ref]

Cardiovascular

Very common (10% or more): Hypotension (57%), tachycardia (57%), arrhythmia (23%), hypertension (15%), thrombosis (10%)
Common (1% to 10%): Cardiac failure, cardiac arrest, capillary leak syndrome[Ref]

Nervous system

Very common (10% or more): Encephalopathy (57%), headache (45%), tremor (31%), dizziness (21%), aphasia (18%)
Common (1% to 10%): Ataxia, seizure, dyscalculia, myoclonus
Frequency not reported: Leukoencephalopathy, cerebral edema[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (50%), decreased appetite (44%), hyponatremia (19%), decreased weight (16%), increased uric acid (13%), dehydration (11%), hypokalemia (10%)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (38%), nausea (34%), vomiting (26%), constipation (23%), abdominal pain (14%), dry mouth (11%)[Ref]

Respiratory

Very common (10% or more): Hypoxia (32%), cough (30%), dyspnea (19%), pleural effusion (13%)
Common (1% to 10%): Pulmonary edema[Ref]

Musculoskeletal

Very common (10% or more): Motor dysfunction (19%), pain in extremity (17%), back pain (15%), muscle pain (14%), arthralgia (10%)[Ref]

Psychiatric

Very common (10% or more): Delirium (17%)
Common (1% to 10%): Insomnia, anxiety[Ref]

Hepatic

Very common (10% or more): Increased direct bilirubin (13%), increased ALT (10%)[Ref]

Renal

Very common (10% or more): Renal insufficiency (12%)[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (94%), hypogammaglobulinemia (15%)[Ref]

References

1. "Product Information. Yescarta (axicabtagene ciloleucel)." Kite Pharma, Inc., El Segundo, CA.

Some side effects of axicabtagene ciloleucel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide