Axicabtagene ciloleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 10, 2023.

Applies to axicabtagene ciloleucel: intravenous suspension.

Serious side effects

Along with its needed effects, axicabtagene ciloleucel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking axicabtagene ciloleucel:

More common

• Agitation
• back pain
• bleeding gums
• bloody urine
• blue lips and fingernails
• blurred vision
• chest pain, discomfort, or tightness
• chills
• confusion as to time, place, or person
• cough
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• decreased frequency or amount of urine
• diarrhea
• difficult, fast, noisy breathing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• holding false beliefs that cannot be changed by fact
• increase in heart rate
• increased blood pressure
• increased menstrual flow or vaginal bleeding
• increased sweating
• increased thirst
• irregular breathing
• irritability
• lightheadedness
• loss of appetite
• loss of consciousness
• lower back or side pain
• mood or mental changes
• muscle, joint, or bone pain
• nausea
• nervousness
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pounding in the ears
• problems with speech or speaking
• prolonged bleeding from cuts
• rapid breathing
• red or black, tarry stools
• red or dark brown urine
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness and unsteady walk
• slow heartbeat
• stiff neck
• sunken eyes
• swelling of the face, fingers, feet, or lower legs
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thirst
• trembling or shaking of the hands or feet
• trouble breathing
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting
• weight gain
• wrinkled skin

Less common

• Cloudy urine
• muscle twitching or jerking
• rhythmic movement of the muscles
• stomach pain
• unusual bleeding or bruising

Incidence not known

• Difficulty in moving or walking
• difficulty swallowing
• muscle stiffness

Other side effects

Some side effects of axicabtagene ciloleucel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• decreased appetite and weight
• pain in the arms or legs

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

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), coagulopathy^[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, neuropathy, seizure, dysphasia

Frequency not reported: Leukoencephalopathy, cerebral edema

Uncommon (0.1% to 1%): Spinal cord edema, myelitis, quadriplegia^[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%)

Common (1% to 10%): Hypocalcemia, hypoalbuminemia^[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%), anxiety

Common (1% to 10%): Insomnia^[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%), unspecified pathogen infections, viral infections, bacterial infections, histiocytosis hematophagic

Common (1% to 10%): Fungal infections^[Ref]

Frequently asked questions

• What is the cost of Yescarta?
• How is Yescarta administered?
• What type of drug is Yescarta (axicabtagene ciloleucel)?

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.

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