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