Possible serious side effects of Breyanzi® chimeric antigen receptor (CAR) T cell therapy

Breyanzi may cause side effects, such as cytokine release syndrome and neurologic toxicity, that are life-threatening and can lead to death. These are not all the possible side effects of Breyanzi. Your healthcare team will be trained on how to manage these serious side effects that you may experience after receiving Breyanzi.

Cytokine release syndrome (CRS)

Cytokine release syndrome, or CRS, is a condition that is life-threatening and can lead to death. It can occur after the Breyanzi infusion and is caused by a quick release of cytokines (a type of protein) into the blood.

In the clinical study

CAR T Cell Therapy Side Effects; 46% (122/268) Any Grade Cytokine Release Syndrome (CRS)

of people who received Breyanzi experienced CRS (any grade from mild to fatal)

CAR T Cell Therapy Side Effects; 46% (122/268) Any Grade Cytokine Release Syndrome (CRS)

of people who received Breyanzi experienced CRS (any grade from mild to fatal)

  • 4% of people experienced severe to fatal CRS
  • One patient had fatal CRS and 2 had ongoing CRS at time of death
  • In the clinical study, the median time it took for CRS to occur after infusion was 5 days, and the length of time it lasted was a median of 5 days
    • Median means half of the people had a larger/longer result while half of the people had a smaller/shorter result
  • CRS generally occurred 1 to 15 days after receiving Breyanzi and lasted 1 to 30 days

Neurologic toxicity

Neurologic toxicity is a condition that is life-threatening and can lead to death. It can occur after the Breyanzi infusion and it affects the body’s nervous system and can make you feel unlike yourself.

In the clinical study

CAR T Cell Therapy Side Effects; 35% (95/268) Any Grade Neurologic Toxicity

of people who received Breyanzi experienced neurologic toxicity (any grade from mild to fatal)

CAR T Cell Therapy Side Effects; 35% (95/268) Any Grade Neurologic Toxicity

of people who received Breyanzi experienced neurologic toxicity (any grade from mild to fatal)

  • 12% experienced severe to fatal neurologic toxicity
  • Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death
  • In the clinical study, the median time it took for the first neurologic event to occur after infusion was 8 days, and the length of time it lasted was a median of 15 days
  • Neurologic toxicity generally occurred 1 to 46 days after receiving Breyanzi and lasted 1 day to just over 2 years

If you have a fever (100.4ºF/38ºC or higher) or show any other signs or symptoms of CRS or neurologic toxicity, immediately call your healthcare provider or go to the emergency room as instructed by your healthcare team.

If you have questions about starting treatment, or are wondering about available treatment support, Cell Therapy 360® is here to help.

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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.