Applies to brexucabtagene autoleucel: intravenous suspension.

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]