BREYANZI® (lisocabtagene maraleucel) suspension for intravenous infusion

BREYANZI® (lisocabtagene maraleucel) suspension for intravenous infusion 

Initial U.S. Approval: 2021 

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES 
See full prescribing information for complete boxed warning. 

• Cytokine Release Syndrome (CRS), including fatal or lifethreatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. 
• Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. 
• BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS

INDICATIONS AND USAGE 
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of 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. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

DOSAGE AND ADMINISTRATION 
For autologous use only. For intravenous use only. 
• Do NOT use a leukodepleting filter. 
• Administer a lymphodepleting regimen of fludarabine and cyclophosphamide before infusion of BREYANZI. 
• Verify the patient’s identity prior to infusion. 
• Premedicate with acetaminophen and an H1 antihistamine. 
• Confirm availability of tocilizumab prior to infusion. 
• Dosing of BREYANZI is based on the number
• The dose is 50 to 110 × 106 CAR-positive viable T cells (consisting of CD8 and CD4 components) . 
• Administer BREYANZI in a certified healthcare facility. 

DOSAGE FORMS AND STRENGTHS 

• BREYANZI is a cell suspension for infusion. • A single dose of BREYANZI contains 50 to 110 × 106 CARpositive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components), with each component supplied separately in one to four single-dose 5 mL vials. Each mL contains 1.5 × 106 to 70 × 106 CAR-positive viable T cells.

CONTRAINDICATIONS 
None (4).

 WARNINGS AND PRECAUTIONS 
• Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. 
• Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately.
 • Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following BREYANZI infusion. Monitor complete blood counts . 
• Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy.
• Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery for at least 8 weeks after BREYANZI administration. 

ADVERSE REACTIONS
 The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) in BREYANZI-treated patients were fatigue, cytokine release syndrome, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema. 

Source 
https://www.fda.gov/media/145711/download

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