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Yescarta Side Effects

Generic name: axicabtagene ciloleucel

Medically reviewed by Drugs.com. Last updated on Nov 12, 2023.

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

Less common

Incidence not known

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

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

References

1. Product Information. Yescarta (axicabtagene ciloleucel). Kite Pharma, Inc. 2017.

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.