Brexucabtagene Autoleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 24, 2024.

Applies to brexucabtagene autoleucel: intravenous suspension.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Tell your doctor right away if pregnancy occurs while you are using this medicine.

This medicine may cause cytokine release syndrome (CRS). This may be life-threatening and requires immediate attention. Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), which is caused by an overactive immune system. Check with your doctor right away if you have a fever, cough that does not go away, right upper abdominal or stomach pain and fullness, rash, redness in one part of your body, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, seizures, or warm feeling or swelling of your skin.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.

While you are being treated with brexucabtagene autoleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

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:

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:

For healthcare professionals

Applies to brexucabtagene autoleucel: intravenous suspension.

General adverse events

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]

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]

Hematologic

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

See also:

Further information

Brexucabtagene autoleucel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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