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Axicabtagene ciloleucel Side Effects

For the Consumer

Applies to axicabtagene ciloleucel: intravenous suspension

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
  • bloody urine
  • blue lips and fingernails
  • blurred vision
  • chest pain or discomfort
  • chills
  • confusion as to time, place, or person
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • 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
  • extreme tiredness or weakness
  • 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 sweating
  • increased thirst
  • irregular breathing
  • irritability
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • mood or mental changes
  • muscle or joint pain
  • nausea
  • nervousness
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • problems with speech or speaking
  • rapid breathing
  • 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
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • troubled 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

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
  • difficulty in moving
  • muscle stiffness
  • pain in the joints, 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

-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.

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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