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.

Before getting BREYANZI, tell your healthcare provider about all your medical problems, including if you have or have had:

• Neurologic problems (such as seizures, stroke, or memory loss)

• Lung or breathing problems

• Heart problems

• Liver problems

• Kidney problems

• A recent or active infection

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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 (intravenous infusion). 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 after infusion, you will be monitored daily by the facility where you received your treatment.

• You should plan to stay within 2 hours of the location where you received your treatment 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. 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 do 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

• low blood pressure

• muscle pain

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.

BREYANZI may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

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. For more information, go to BREYANZI.com or call 1-888-805-4555. You may report side effects 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.

Indications

BREYANZI is a prescription medicine used to treat 4 types of non-Hodgkin lymphoma:

• Large B cell lymphoma, when:
  • your first treatment has not worked or your cancer returned within a year of your first treatment, OR
  • your first treatment has not worked or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age, OR
  • two or more kinds of treatment have not worked or stopped working.
• Chronic lymphocytic leukemia or small lymphocytic lymphoma when two or more kinds of treatment have not worked or stopped working.
• Follicular lymphoma, when two or more kinds of treatment have not worked or stopped working.
• Mantle cell lymphoma when two or more kinds of treatment have not worked or stopped working, including a prior Bruton tyrosine kinase (BTK) inhibitor medicine.

BREYANZI is different than other cancer medicines because it is made from your own white blood cells, which have been genetically modified to recognize and attack your lymphoma cells.