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Yescarta

Generic Name: axicabtagene ciloleucel (AKS ee KAB ta jeen SYE loe LOO sel)
Brand Names: Yescarta
Yescarta (axicabtagene ciloleucel) is an immunotherapy medicine used to treat large B-cell lymphoma in adults. This medicine is given after at least two other treatments have failed.
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Drug Information:
Yescarta (axicabtagene ciloleucel) is an immunoTherapy medicine used to treat large B-cell lymphoma in adults. This medicine is given after at least two other treatments have failed. Yescarta is made from your own white blood cells, removed from a small amount of blood drawn from your body. Yescarta is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine. A serious side effect of Yescarta is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs. Learn more

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Yescarta Side Effects

Note: This document contains side effect information about axicabtagene ciloleucel. Some of the dosage forms listed on this page may not apply to the brand name Yescarta.

For the Consumer

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(TM) REMS.

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
  • 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.

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.

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)

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

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

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

Metabolic

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

Gastrointestinal

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

Respiratory

Very common (10% or more): Hypoxia (32%), cough (30%), dyspnea (19%), pleural effusion (13%)

Common (1% to 10%): Pulmonary edema

Musculoskeletal

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

Psychiatric

Very common (10% or more): Delirium (17%)

Common (1% to 10%): Insomnia, anxiety

Hepatic

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

Renal

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

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction

Dermatologic

Common (1% to 10%): Rash

Immunologic

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

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Yescarta (www.drugs.com/yescarta.html).