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A single dose of Lisocabtagene Maraleucel contains a 1:

• 1 CAR-positive viable T cells of the CD8 and CD4 components. Each component is 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.

Lisocabtagene Maraleucel is a type of immunotherapy used to treat adults with relapsed or advanced large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), follicular lymphoma (FL) , or mantle cell lymphoma (MCL).

Lisocabtagene Maraleucel is an immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. With this treatment, your T-cells are removed from your body and sent to a lab. They are then modified to find and attack certain cancer cells in your body. Once this is done, the T-cells are infused back into your body to kill those specific cancer cells.

Once your immune cells are collected and modified, you will be given a regimen of fludarabine and cyclophosphamide. Prior to the infusion you will be pretreated with acetaminophen and an H1 antihistamine. Then Lisocabtagene Maraleucel will be infused into your veins in two back-to-back 15-minute infusions.

Breyzani is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Lisocabtagene Maraleucel:

• Low white blood cell count
• Fever
• Cytokine release syndrome
• Low platelet count
• Muscle pain
• Headache
• Low red blood cell count
• Tiredness
• Nausea
• Constipation
• Dizziness
• Trouble sleeping
• Tremors
• Muscle spasms or weakness
• Diarrhea
• Stomach pain

Serious side effects are rare with Lisocabtagene Maraleucel. Contact your healthcare provider immediately if you experience any of the following:

• Cytokine release syndrome: Fever, trouble breathing, chills, low blood pressure, changes in heart rhythm, headache
• Serious nervous system problems: headache, confusion, difficulty speaking, difficulty writing, seizures
• Serious infection: fever, body aches, fast heartbeat, chills
• Serious bleeding (from low platelets): nosebleeds, blood in urine, blood in stool, bruising that won’t go away, bleeding that’s difficult to stop, stomach pains

The following medications may interact with Lisocabtagene Maraleucel:

• Some commercial HIV nucleic acid tests may yield false-positive results in patients who have received this medication.

Various FDA-approved generic manufacturers

It is not known whether this medication is safe for you and your unborn baby during pregnancy. Talk to your doctor if you are already pregnant or if you have plans on becoming pregnant. They will recommend what is best for you.

• Breyanzi