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Breyanzi

Last reviewed on RxList: 2/11/2021
Breyanzi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Breyanzi?

Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T cell immunotherapy used to treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

What Are Side Effects of Breyanzi?

Side effects of Breyanzi include:

Dosage for Breyanzi

Dosing of Breyanzi is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. The dose of Breyanzi is 50 to 110 × 106 CAR-positive viable T cells (consisting of CD8 and CD4 components).

Breyanzi In Children

Safety and effectiveness of Breyanzi have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Breyanzi?

Breyanzi may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Breyanzi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Breyanzi; it is unknown how it would affect a fetus. It is unknown if Breyanzi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Breyanzi Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in the labeling:

  • Cytokine Release Syndrome [see WARNINGS AND PRECAUTIONS]
  • Neurologic Toxicities [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Prolonged Cytopenias [see WARNINGS AND PRECAUTIONS]
  • Hypogammaglobulinemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described in this section reflect exposure to BREYANZI in the TRANSCEND study, in which 268 adult patients with R/R large B-cell lymphoma received a flat dose of CAR-positive viable T cells [see Clinical Studies]. Patients with a history of CNS disorders (such as seizures or cerebrovascular ischemia) or autoimmune disease requiring systemic immunosuppression were ineligible. The median duration of follow-up was 9 months. The median age of the study population was 63 years (range: 18 to 86 years); 65% were male. The Eastern Cooperative Oncology Group (ECOG) performance status at screening was 0 in 41% of patients, 1 in 58% of patients, and 2 in 1.5% of patients.

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

Table 3 presents the adverse reactions reported in at least 10% of patients treated with BREYANZI, and Table 4 describes the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients.

The most common nonlaboratory adverse reactions of any grade (≥ 20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Table 3: Summary of Adverse Reactions Observed in at Least 10% of the Patients Treated with BREYANZI in the TRANSCEND Study (N=268)

Adverse ReactionAny Grade (%)Grade 3 or Higher (%)
Cardiac disorders
Tachycardiaa250
Gastrointestinal disorders
Nausea331.5
Diarrhea260.4
Constipation230
Abdominal painb213.0
Vomiting210.4
General disorders and administration site conditions
Fatiguec483.4
Edemad211.1
Fever160
Chills120
Immune system disorders
Cytokine release syndrome464.1
Hypogammaglobulinemiae320
Infections and infestationsf
Infections - pathogen unspecifiedg2916
Bacterial infectious disordersh135
Upper respiratory tract infectioni130.7
Viral infectious disorders101.5
Metabolism and nutrition disorders
Decreased appetite282.6
Musculoskeletal and connective tissue disorders
Musculoskeletal pain j372.2
Motor dysfunctionk101.1
Nervous system disorders
Headachel301.1
Encephalopathym299
Dizzinessn242.6
Tremoro160
Peripheral neuropathyp110
Aphasiaq102.2
Psychiatric disorders
Insomniar140.4
Anxietys100
Deliriumt102.2
Renal and urinary disorders
Renal failureu113.0
Respiratory, thoracic, and mediastinal disorders
Coughv230
Dyspneaw162.6
Skin and subcutaneous tissue disorders
Rashx130.4
Vascular disorders
Hypotensiony263.4
Hypertension144.5
Hemorrhagez101.5
a Tachycardia includes heart rate increased, sinus tachycardia, tachycardia.
b Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness.
c Fatigue includes asthenia, fatigue, malaise.
d Edema includes edema, edema peripheral, fluid overload, fluid retention, generalized edema, hypervolemia, peripheral swelling, pulmonary congestion, pulmonary edema, swelling.
e Hypogammaglobulinemia includes subjects with adverse events of hypogammaglobulinemia (14%) and/or laboratory IgG levels that fell below 500 mg/dL after infusion (21%).
f Infections and infestations are grouped by pathogen type and selected clinical syndromes.
g Infections – pathogen unspecified contains febrile neutropenia (9%).
h Bacterial infection includes infections by pathogen type plus appendicitis, diverticulitis, peritonitis, skin infection, tooth infection.
i Upper respiratory tract infections include nasopharyngitis, pharyngitis, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract congestion, upper respiratory tract infection.
j Musculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, pain in extremity, spinal pain.
k Motor dysfunction includes eyelid ptosis, motor dysfunction, muscle rigidity, muscle spasms, muscle spasticity, muscle tightness, muscle twitching, muscular weakness, myoclonus, myopathy.
l Headache includes headache, head discomfort, migraine, sinus headache.
m Encephalopathy includes amnesia, bradyphrenia, cognitive disorder, confusional state, depersonalization/derealization disorder, depressed level of consciousness, disturbance in attention, encephalopathy, flat affect, hypersomnia, incoherent, lethargy, leukoencephalopathy, loss of consciousness, memory impairment, mental impairment, mental status changes, somnolence.
n Dizziness includes dizziness, presyncope, syncope, vertigo.
o Tremor includes essential tremor, resting tremor, tremor.
p Peripheral neuropathy includes hyperesthesia, hypoesthesia, meralgia paresthetica, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, sciatica, sensory loss.
q Aphasia includes aphasia, disorganized speech, dysarthria, dysphemia, dysphonia, slow speech, speech disorder.
r Insomnia includes insomnia, somnambulism.
s Anxiety includes anxiety, panic attack.
t Delirium includes agitation, delirium, delusion, disorientation, hallucination, ‘hallucination, visual’, irritability, restlessness.
u Renal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal injury.
v Cough includes cough, productive cough, upper-airway cough syndrome.
w Dyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure.
x Rash includes erythema, dermatitis acneiform, perineal rash, rash, rash erythematous, rash macular, rash maculopapular, rash morbilliform, rash papular, rash pruritic, rash pustular.
y Hypotension includes hypotension, orthostatic hypotension.
z Hemorrhage includes catheter site hemorrhage, conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemorrhage, hemorrhage intracranial, pulmonary hemorrhage, retinal hemorrhage, vaginal hemorrhage.

Other clinically important adverse reactions that occurred in less than 10% of patients treated with BREYANZI include the following:

  • Blood and lymphatic system disorders: Coagulopathy (1.5%)
  • Cardiac disorders: Arrhythmia (6%), cardiomyopathy (1.5%)
  • Gastrointestinal disorders: Gastrointestinal hemorrhage (4.1%)
  • Infections and infestations: Pneumonia (8%), fungal infections (8%), sepsis (4.5%), urinary tract infection (4.1%)
  • Injury, poisoning, and procedural complications: Infusion-related reaction (1.9%)
  • Metabolism and nutrition disorders: Tumor lysis syndrome (0.7%)
  • Nervous system disorders: Ataxia/gait disturbance (7%), visual disturbance (5%), paresis (2.6%), cerebrovascular events (1.9%), seizure (1.1%), brain edema (0.4%)
  • Respiratory, thoracic, and mediastinal disorders: Pleural effusion (7%), hypoxia (6%)
  • Vascular disorder: Thrombosis (7%)

Table 4: Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Occurring in ≥ 10% of Patients Following Treatment with BREYANZI in the TRANSCEND Studya (N=268)

Laboratory AbnormalityGrade 3 or 4 (%)
Neutropenia76
Thrombocytopenia39
Anemia23
Hypofibrinogenemia15
Hypophosphatemia13
a NCI CTCAE=Common Terminology Criteria for Adverse Events version 4.03.

Immunogenicity

BREYANZI has the potential to induce anti-product antibodies. The immunogenicity of BREYANZI has been evaluated using an electrochemiluminescence (ECL) immunoassay for the detection of binding antibodies against the extracellular CD19-binding domain of BREYANZI. Preexisting anti-product antibodies were detected in 11% (28/261) of patients. Treatment-induced or treatment-boosted anti-product antibodies were detected in 11% (27/257) of patients. Due to the small number of patients who had anti-product antibodies, the relationship between anti-product antibody status and efficacy, safety, or pharmacokinetics was not conclusive.

Read the entire FDA prescribing information for Breyanzi (Lisocabtagene Maraleucel Suspension for Intravenous Infusion)

Related Resources for Breyanzi

© Breyanzi Patient Information is supplied by Cerner Multum, Inc. and Breyanzi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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