BREYANZI is a prescription medicine used to treat a type 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...Read more
See links below for full Prescribing Information, including Boxed WARNINGS and Medication Guide.
*The treatment process includes blood collection, chimeric antigen receptor (CAR) T cell creation, administration, and side-effect monitoring.
Not actual patients or care partner.
Please see full Prescribing Information, including Boxed WARNINGS and
Medication Guide.
Indications
BREYANZI is a prescription medicine used to treat a type 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.
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.
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.
Full Prescribing Information, including Boxed WARNINGS and Medication Guide
DOWNLOAD
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.
A one-time* infusion of Breyanzi involves a few different steps, which take about 2 to 3 months from start to finish. Your healthcare team will be with you throughout the process.
STEP 1:
Blood collection
(apheresis)
STEP 2:
Creating Breyanzi
STEP 3:
One-time* infusion of
Breyanzi
Initial follow-up monitoring: After your infusion, you will be monitored every day for a week. Plan to stay close to the treatment center for at least 4 weeks.†
Initial follow-up monitoring: After your infusion, you will be monitored every day for a week. Plan to stay close to the treatment center for at least 4 weeks.†
*The treatment process includes blood collection, CAR T cell creation, administration, and side-effect monitoring.
†Some patients treated with Breyanzi may develop other cancers. Your healthcare team will provide lifelong monitoring for these cancers.
Breyanzi will be given at an authorized treatment center by a specially trained healthcare team. They will decide if it is possible for you to receive your infusion without continuing to stay at the treatment center.
STEP 1:
Blood collection
Your white blood cells will be collected through a process called apheresis (sometimes called leukapheresis)
- Your blood is drawn, and the components are separated into groups
- Your T cells are collected and the other parts of your blood are returned back into your body
- Apheresis can be done in 1 day and usually takes 2 to 6 hours
STEP 2:
Creating Breyanzi
Making your Breyanzi CAR T cells
- Your T cells will be sent to a special manufacturing site where the
hooks–CARs–will be added. This may take about 3 to 4 weeks, but time can vary - During this time, you may receive other treatments for the large B-cell lymphoma
STEP 3:
Receiving Breyanzi
Before your Breyanzi infusion, you’ll receive low-dose chemotherapy
- You’ll receive 3 days of a low-dose chemotherapy, called lymphodepleting chemotherapy, to help prepare your body for Breyanzi
You’ll be given Breyanzi as a one-time infusion*
- Through this infusion, you’ll receive 2 different types of cells given one right after the other
- The time for infusion will vary but will usually be less than 15 minutes for each of the 2 cell types
*2–7 days after receiving low-dose chemotherapy.
Monitoring
You’ll be closely monitored for side effects following your Breyanzi infusion
- Breyanzi will be given at an authorized treatment center by a specially trained healthcare team. Your doctor will decide if you need to stay in the hospital or if you can leave after treatment
- During the first week, you will be monitored daily by the facility where you receive Breyanzi. Plan to stay close to this location for at least 4 weeks after infusion
- 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
Follow-up monitoring
- 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
Long-term monitoring for secondary cancers
- Some patients treated with Breyanzi may develop other cancers. Your healthcare team will provide lifelong monitoring for these cancers
[My doctor] said to think of [my CAR T cells] as little soldiers that are there to help kill the lymphoma cells. The cells that were altered would recognize lymphoma cells, as well as some healthy cells, and attack them.”
—Karla, treated with Breyanzi
