Note: This document contains side effect information about axicabtagene ciloleucel. Some dosage forms listed on this page may not apply to the brand name Yescarta.
Applies to axicabtagene ciloleucel: intravenous suspension.
Warning
Intravenous route (Suspension)
Cytokine release syndrome and neurologic toxicitiesCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel. Do not administer axicabtagene ciloleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with axicabtagene ciloleucel. Provide supportive care and/or corticosteroids as needed.Axicabtagene ciloleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
Serious side effects of Yescarta
Along with its needed effects, axicabtagene ciloleucel (the active ingredient contained in Yescarta) 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 of Yescarta
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]
