Breyanzi Side Effects

Generic name: lisocabtagene maraleucel

Medically reviewed by Drugs.com. Last updated on Jul 21, 2024.

Note: This document provides detailed information about Breyanzi Side Effects associated with lisocabtagene maraleucel. Some dosage forms listed on this page may not apply specifically to the brand name Breyanzi.

Applies to lisocabtagene maraleucel: intravenous suspension.

Serious side effects of Breyanzi

Along with its needed effects, lisocabtagene maraleucel (the active ingredient contained in Breyanzi) 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 lisocabtagene maraleucel:

Other side effects of Breyanzi

Some side effects of lisocabtagene maraleucel 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 lisocabtagene maraleucel: intravenous suspension.

General adverse events

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (2% or greater) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity/anaphylaxis^[Ref]

Immunologic

• Very common (10% or more): Cytokine release syndrome (79%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%), hypogammaglobulinemia (e.g., hypogammaglobulinemia, immunoglobulins decreased, blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased) (43%), infections pathogen unspecified (41%), viral infections (26%), bacterial infections (19%), fungal infections (13%)
• Common (1% to 10%): Graft versus host disease
• Frequency not reported: Immunogenicity^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (15%), arthralgia (12%), back pain/pain in extremity (10%)
• Common (1% to 10%): Muscle spasms^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (37%), hypophosphatemia (24%), edema (e.g., face edema, generalized edema, localized edema, edema peripheral) (21%), hypokalemia (12%), hyponatremia (11%), weight loss (11%), fluid overload (10%)
• Common (1% to 10%): Tumor lysis syndrome^[Ref]

Psychiatric

• Very common (10% or more): Delirium (21%), anxiety (13%), sleep disorders/insomnia/nightmare (10%)^[Ref]

Hepatic

• Very common (10% or more): Acute kidney injury (e.g., acute kidney injury, anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, blood creatinine increased) (24%), increased alanine aminotransferase (21%), increased bilirubin (21%)

Oncologic

• Frequency not reported: Secondary malignancies/cancer recurrence^[Ref]

Respiratory

• Very common (10% or more): Hypoxia (24%), cough/productive cough (21%), dyspnea/respiratory distress/respiratory failure (16%), pulmonary edema (16%), tachypnea (12%), pleural effusion (10%), nasal congestion (10%)
• Common (1% to 10%): Respiratory distress, respiratory failure, acute respiratory distress syndrome, oropharyngeal pain^[Ref]

Other

• Very common (10% or more): Fatigue/malaise (48%), pyrexia (40%), increased aspartate aminotransferase (28%), hypokalemia (27%), hypophosphatemia pain (18%), fever (16%), chills (12%)
• Common (1% to 10%): Multiple organ dysfunction syndrome^[Ref]

Hematologic

• Very common (10% or more): Lymphopenia (94%), neutropenia (81%), leukopenia (77%), anemia (58%), thrombocytopenia (54%), febrile neutropenia (37%), bleeding episodes (31%), international normalized ratio increased (13%)
• Common (1% to 10%): Histiocytosis lymphocytic hemophagocytosis, coagulopathy, activated partial thromboplastin time prolonged^[Ref]

Nervous system

• Very common (10% or more): Headache/migraine (30%), encephalopathy (e.g., encephalopathy, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, lethargy, mental status changes, somnolence, automatism) (29%), delirium (e.g., delirium, agitation, hallucination, hallucination visual, irritability, restlessness) (21%), peripheral neuropathy (11%)
• Common (1% to 10%): Tremor, dizziness, seizure, speech disorder/aphasia/dysarthria, motor dysfunction^[Ref]

Renal

• Very common (10% or more): Acute kidney injury (24%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (26%), tachycardia/sinus tachycardia (25%)
• Common (1% to 10%): Disseminated intravascular coagulation, cardiac arrest, cardiac failure, capillary leak syndrome, thrombosis^[Ref]

Dermatologic

• Very common (10% or more): Rash/rash maculopapular/rash papular/rash pruritic (16%)^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (33%), diarrhea (26%), constipation (23%), vomiting (21%), abdominal pain (21%)^[Ref]

Ocular

• Common (1% to 10%): Visual impairment^[Ref]

Frequently asked questions

• What is the success rate of Breyanzi?

Further information

Breyanzi 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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