For questions about BMS medicines during this time please call 1-800-721-8909.

Antigen: Any substance that causes the body to make an immune response against that substance. Antigens include toxins, chemicals, bacteria, viruses, or other substances that come from outside the body. Other cells throughout the body can also have antigens on them.

Apheresis: The process of taking blood out of the body, removing certain parts of the blood, and then reintroducing the blood back into the body. This process is done in CAR T cell therapy to remove T cells before adding CARs to them. May also be called leukapheresis.

Authorized treatment center: The place where you will receive Breyanzi CAR T cell therapy. The healthcare team at these centers have been specially trained on how to administer and manage side effects of CAR T cell therapy.

Cancer immunotherapy: A treatment option that uses a person’s immune system to help fight cancer.

CAR (chimeric antigen receptor): A specific receptor (or hook) that is added to a person’s T cells. The receptor can find and fight specific cells.

CAR T cell: A T cell with the specific CAR added to it.

CAR T cell therapy: A type of treatment that uses a person’s T cells to fight certain blood cancers.

Clinical study: A research study that tests the safety and effectiveness of a medicine in people with certain diseases.

Cytokine: A type of protein that is made by certain immune and non-immune cells and has an effect on the immune system. Some cytokines stimulate the immune system and others slow it down.

Cytokine release syndrome (CRS): A side effect of CAR T cell therapy that is potentially life-threatening and can lead to death. It is caused by a large, rapid release of cytokines, a type of protein, into the blood.

Immune system: The body’s natural defense against infection and diseases, including cancer.

Infusion: The method of putting fluids, including medicine, into the bloodstream using an intravenous (IV) method.

Manufacturing site: Where your T cells will be sent to become Breyanzi CAR T cells.

Neurologic toxicity: A side effect of CAR T cell therapy that is potentially life-threatening and can lead to death. It can cause damage to the nervous system.

T cell: A type of cell found in the immune system that plays a role in fighting disease, including cancer.

Breyanzi is only available at authorized treatment centers. Find the closest center to you.

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Important Safety Information

What is the most important information I should know about BREYANZI?

BREYANZI may cause side effects that are life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:

  • difficulty breathing
  • fever (100.4°F/38°C or higher)
  • chills/shaking chills
  • confusion
  • severe nausea, vomiting, diarrhea
  • fast or irregular heartbeat
  • dizziness/lightheadedness
  • severe fatigue or weakness

Important Safety Information

What is the most important information I should know about BREYANZI?

BREYANZI may cause side effects that are life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:

  • difficulty breathing
  • fever (100.4°F/38°C or higher)
  • chills/shaking chills
  • confusion
  • severe nausea, vomiting, diarrhea
  • fast or irregular heartbeat
  • dizziness/lightheadedness
  • severe fatigue or weakness

It is important that you tell your healthcare providers that you have received BREYANZI and to show them your BREYANZI Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

How will I receive BREYANZI?

  • BREYANZI is made from your own white blood cells, so your blood will be collected by a process called leukapheresis.
  • It takes about 3-4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
  • Before you get BREYANZI, you will get 3 days of chemotherapy to prepare your body.
  • When your BREYANZI is ready, your healthcare provider will give it to you through a catheter placed into your vein. BREYANZI is given as infusions of 2 different cell types.
    • You will receive infusions of one cell type, immediately followed by the other cell type.
    • The time for infusion will vary, but will usually be less than 15 minutes for each of the 2 cell types.
  • During the first week, you will be monitored daily by the facility where you received your treatment.
  • You should plan to stay close to this location for at least 4 weeks after getting BREYANZI. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
  • You may be hospitalized for side effects and your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital.
  • Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving BREYANZI?

  • Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get BREYANZI. This is because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, dizziness, and seizures.
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of BREYANZI?

The most common side effects of BREYANZI are:

  • fatigue
  • difficulty breathing
  • fever (100.4°F/38°C or higher)
  • chills/shaking chills
  • confusion
  • difficulty speaking or slurred speech
  • severe nausea, vomiting, diarrhea
  • headache
  • dizziness/lightheadedness
  • fast or irregular heartbeat
  • swelling

BREYANZI can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

BREYANZI can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.

Having BREYANZI in your blood may cause a false-positive HIV test result by some commercial tests.

These are not all the possible side effects of BREYANZI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Indication

BREYANZI is for the treatment of large B-cell lymphoma in patients when at least 2 previous treatments have not worked or have stopped working. BREYANZI is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your lymphoma cells.