Brexucabtagene autoleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 29, 2022.

Applies to brexucabtagene autoleucel: intravenous suspension.

Warning

Intravenous route (Suspension)

Warning: Cytokine Release Syndrome and Neurologic ToxicitiesCytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving brexucabtagene autoleucel. Do not administer brexucabtagene autoleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurologic toxicities, including life-threatening reactions, occurred in patients receiving brexucabtagene autoleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with brexucabtagene autoleucel. Provide supportive care and/or corticosteroids, as needed.Brexucabtagene autoleucel is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta(TM) and Tectartus(TM) REMS Program.

Serious side effects

Along with its needed effects, brexucabtagene autoleucel 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 brexucabtagene autoleucel:

More common

Agitation
anxiety
back pain
bloody urine
blurred vision
chest pain or tightness
chills
coma
confusion as to time, place, or person
cough
decreased frequency in urinating
diarrhea
difficulty swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drooling
drowsiness
dry mouth
fast, pounding, or irregular heartbeat or pulse
fever
hallucinations
headache
heartburn
hoarseness
holding false beliefs that cannot be changed by fact
increased thirst
irritability
loss of appetite
lower back or side pain
mood or mental changes
muscle or bone pain
muscle spasm or twitching
nausea and vomiting
problems with speech or speaking
seizures
stiff neck
stomach pain
sweating
swelling of the face, fingers, feet, or lower legs
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site
trouble breathing
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
weight gain

Less common

Blue lips and fingernails
difficult, fast, noisy breathing
pale skin
unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

Dark urine
hives, itching, skin rash
light-colored stools
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
upper right stomach pain
yellow eyes and skin

Other side effects

Some side effects of brexucabtagene autoleucel 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
trouble sleeping

Less common

Darkening of the skin
dry skin
increased sweating
loss or thinning of the hair

For Healthcare Professionals

Applies to brexucabtagene autoleucel: intravenous suspension.

Hematologic

Very common (10% or more): Leukopenia (95%), neutropenia (95%), thrombocytopenia (63%), anemia (55%)^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity, anaphylaxis^[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (all Grades: 91%; Grade 3: 18%), infection pathogen unspecified (43%), viral infection (18%), hypogammaglobulinemia (e.g., hypogammaglobulinemia, blood immunoglobulin G decreased) (16%), bacterial infection (13%)

Common (1% to 10%): Fungal infections

Frequency not reported: Immunogenicity^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., arthralgia, back pain, bone pain, dysarthria, flank pain, groin pain, myalgia, neck pain, pain in extremity (37%), motor dysfunction (e.g., asthenia, intensive care acquired weakness, mobility decreased, muscle twitching, muscular weakness, myopathy) (17%)^[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (30%), anorexia (26%), hypocalcemia (21%), hypokalemia (10%)

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

Psychiatric

Very common (10% or more): Insomnia (21%), delirium (e.g., delirium, agitation, disorientation, hallucination, hypomania, irritability, nervousness, personality change) (38%), anxiety (16%)^[Ref]

Genitourinary

Very common (10% or more): Coagulopathy (e.g., coagulopathy, disseminated intravascular coagulation, international normalized ratio increased) (10%)^[Ref]

Hepatic

Very common (10% or more): Aspartate aminotransferase increased (15%), alanine aminotransferase increased (15%)^[Ref]

Oncologic

Frequency not reported: Secondary malignancies^[Ref]

Respiratory

Very common (10% or more): Hypoxia (40%), cough/upper airway cough syndrome (38%), dyspnea/dyspnea exertional (24%), pleural effusion (21%)

Common (1% to 10%): Respiratory failure, pulmonary edema^[Ref]

Other

Very common (10% or more): Pyrexia (94%), fatigue/lethargy/malaise (48%), chills 41%), edema (e.g., eyelid edema, face edema, generalized edema, localized edema, edema peripheral, periorbital edema, peripheral swelling, scrotal edema, swelling face) (35%), pain (e.g., allodynia, dysesthesia, ear pain, facial pain, non-cardiac chest pain) (17%)^[Ref]

General

The most common adverse reactions (20% or greater) are: pyrexia, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection (pathogen unspecified), chills, hypoxia, cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, and aphasia.^[Ref]

Nervous system

Very common (10% or more): Encephalopathy (e.g., encephalopathy, altered state of consciousness, amnesia, balance disorder, cognitive disorder, confusional state, disturbance in attention, dysgraphia, dyskinesia, memory impairment, mental status changes, neurotoxicity, somnolence) (51%), tremor (38%), headache/migraine (35%), aphasia/ communication disorder (20%), dizziness (e.g., dizziness, presyncope, syncope) (18%), neuropathy (e.g., hyperesthesia, neuropathy peripheral, paresthesia, paresthesia oral) (13%)

Common (1% to 10%): Ataxia, seizure, intracranial pressure increased^[Ref]

Cardiovascular

Very common (10% or more): Hypotension/orthostatic hypotension (57%), tachycardia/sinus tachycardia (45%), hypertension (18%), thrombosis (e.g., thrombosis, deep vein thrombosis, embolism, pulmonary embolism) (17%), bradycardia/sinus bradycardia (10%), non-ventricular arrhythmias (e.g., fibrillation, atrial flutter, cardiac flutter, palpitations, supraventricular tachycardia) (10%)

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

Dermatologic

Very common (10% or more): Rash (e.g., erythema, rash erythematous, rash maculopapular, rash pustular) (22%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (35%), constipation (29%), diarrhea (28%), abdominal pain (e.g., abdominal pain lower, abdominal pain upper, abdominal tenderness) (17%), oral pain (e.g., gingival pain, lip pain, oral mucosal erythema, oropharyngeal pain) (16%), vomiting (13%), dysphagia (10%)

Common (1% to 10%): Dry mouth^[Ref]