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Breyanzi
Lisocabtagene Maraleucel
$642040.00
1
BrandBranded medicine· By Bristol Myers Squibb
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FDA boxed warningCytokine release syndrome, neurologic toxicities, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including fatal or life-threatening 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.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
About Breyanzi
Overview
Breyanzi (lisocabtagene maraleucel) is an immunotherapy made from a patient’s own genetically modified T cells. It treats certain large B-cell lymphomas, chronic lymphocytic leukemia, small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma in adults whose disease has returned or not responded to treatment. Eligibility depends on the cancer type and previous treatments and, for some patients with large B-cell lymphoma, whether a stem cell transplant is suitable. The modified T cells recognize a protein called CD19 on cancerous and normal B cells, triggering an immune response that kills those cells.
What it treats
• Large B-cell lymphoma in adults, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and grade 3B follicular lymphoma, when it has not responded to initial chemoimmunotherapy or has returned within 12 months; when it has not responded or has returned after initial chemoimmunotherapy and age or other medical conditions rule out stem cell transplantation; or after two or more systemic treatments have failed or the cancer has returned. Not indicated for primary central nervous system lymphoma. • Chronic lymphocytic leukemia or small lymphocytic lymphoma in adults whose cancer has returned or not responded after at least two previous treatments, including a BTK inhibitor and a BCL-2 inhibitor. This indication has accelerated approval based on response rate and duration; continued approval may depend on confirmatory trials verifying clinical benefit. • Follicular lymphoma in adults whose cancer has returned or not responded after two or more previous systemic treatments. • Mantle cell lymphoma in adults whose cancer has returned or not responded after at least two previous systemic treatments, including a BTK inhibitor. • Marginal zone lymphoma in adults whose cancer has returned or not responded after at least two previous systemic treatments.
Safety information
Side effects
Common side effects vary by the condition being treated. They include cytokine release syndrome (CRS), fever, tiredness, muscle and joint pain, nausea, swelling, diarrhea, and encephalopathy (problems with brain function). CRS is among the most common reactions in every condition listed in the label. Serious reactions that warrant contacting a doctor include CRS, problems with brain function, allergic reactions during infusion, and serious infections. Blood tests may show severely reduced white blood cells, platelets, or hemoglobin. Low blood cell counts can persist for several weeks after infusion and require monitoring. Breyanzi can also cause low immunoglobulin levels, which require monitoring and may need replacement treatment. New cancers, including T-cell cancers, have occurred after treatment with therapies including Breyanzi. Contact your doctor if a new cancer is diagnosed after treatment.
FDA boxed warning
Cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including fatal or life-threatening 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.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no contraindications for Breyanzi. Breyanzi requires monitoring for allergic reactions during infusion and for signs of serious infection. Severely low blood cell counts may persist for several weeks after infusion, so complete blood counts should be monitored. Low immunoglobulin levels also require monitoring, and immunoglobulin replacement therapy may be considered. Secondary cancers, including T-cell cancers, have occurred after treatment with therapies of this type, including Breyanzi. If a secondary cancer develops after treatment, the healthcare team should contact Bristol-Myers Squibb at 1-888-805-4555.
Using Breyanzi
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label BREYANZI (LISOCABTAGENE MARALEUCEL) KIT [JUNO THERAPEUTICS, INC.] (DailyMed, retrieved 19 September 2026).
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