Breyanzi Side Effects

Generic name: lisocabtagene maraleucel

Medically reviewed by Drugs.com. Last updated on Oct 8, 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.

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.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.

This medicine may cause cytokine release syndrome (CRS), which 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 serious allergic reactions, including anaphylaxis, which may 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 lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

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.

While you are being treated with lisocabtagene maraleucel (the active ingredient contained in Breyanzi) 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.

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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Serious side effects of Breyanzi

Along with its needed effects, lisocabtagene maraleucel 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]

See also:

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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