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
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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.
Karla’s Breyanzi® story
Karla’s Breyanzi® story
Breyanzi gave me so much hope. It opened up a future. And that sounded pretty darn good to me.
—Karla
Karla was part of a Breyanzi clinical study. Based on the results of this study, the Food and Drug Administration (FDA) approved Breyanzi for use after 1 treatment didn't work or stopped working (June 2022).
An aching back that became a medical emergency
From water skiing, to playing softball, and getting into golf, Karla was always active.
However, as Karla describes it, she had no idea she was sick. Not until some pain in her back became a medical emergency that involved taking a helicopter to a major medical center.
The back pain was caused by a tumor on her spine, and it needed to be surgically removed. During surgery, the doctor took a sample of her tissues to see what else was going on.
Karla had Stage 4 large B-cell lymphoma. She was stunned.
“It was devastating at first. It was very frightening.”
Other than the intense back pain, Karla had no symptoms that would suggest cancer, such as swollen lymph glands and sweats. Karla took the time to learn that lymphoma is a cancer of the blood, meaning it can travel throughout her whole body.
After the spinal surgery, Karla was unable to walk and was in a wheelchair for awhile. It would be a month before treatment for the cancer could start, so that she had time to recover.
A short-lived benefit
Following spinal surgery, Karla was able to start focusing on treatment for the lymphoma. She had chemotherapy, followed by radiation.
After treatment, Karla was in remission. “I was confident that I was never going to go through this again because I’ve never been sick in my life.” Unfortunately, less than a year later, the cancer came back. Karla was devastated.
I was thinking that I just don’t want to go through chemo or radiation again.
The confidence to try something new
When the cancer came back, Karla was referred to a bone marrow transplant specialist.
One of the first options they talked about was stem cell transplant. The idea of asking a friend or family member for their cells was not something that Karla could do. That’s when the doctor told Karla about Breyanzi CAR T cell therapy—a treatment that uses her own cells to fight the cancer.
Because Karla had already received 1 previous line of treatment that didn’t work or stopped working, Karla was a candidate to receive Breyanzi as a second line of treatment. Karla talked about treatment options with her oncologist and decided to join a Breyanzi clinical trial.
Think of them as little soldiers that are there to help kill the cancer cells
Since Karla had never heard of CAR T cell therapy before, she went to the doctor with the questions she had. Her doctor’s answers helped explain every step, making very clear what was going to happen.This helped Karla to imagine what was happening inside her body.
She explained that they would remove the blood cells. These cells would then be, after a process, returned to me as Breyanzi. She said to think of them as little soldiers that are there to help kill the cancer cells. The cells that were altered would recognize cancer cells, as well as some healthy cells, and attack them.
Karla was curious: CAR T cell therapy meant that she did not have to ask someone for their cells; she would have her own cells back.
They also talked about the possible side effects that are life-threatening or fatal, including cytokine release syndrome and neurologic toxicity, as well as other common side effects, including fever,
See additional Breyanzi Important Safety Information.
While Karla’s daughter thought that choosing CAR T cell therapy was a “no-brainer,” Karla was on the cusp. She had questions. She wasn’t sure.
After careful consideration, Karla and her doctor felt Breyanzi was the right choice for her. Once the decision was made, things moved forward quickly.
Things got interesting on treatment day
Karla was looking forward to what she hoped would be her second, and last, line of treatment.
“Up to this point, you’re getting ready for it. You're preparing your body to receive treatment. And, oh my gosh, that day of getting those cells injected was when it got really interesting because you think, okay, this is it. It was a very exciting time.”
Karla stayed in the hospital after treatment to be monitored in case she experienced side effects. Her healthcare team took her temperature and monitored her bloodwork closely. Side effects with Breyanzi treatment will vary from patient to patient. Breyanzi can cause side effects that may be life-threatening and can lead to death, such as cytokine release syndrome and neurologic toxicities. Because of the risk of cytokine release syndrome, neurologic toxicity, and other side effects, patients like Karla must remain at, or close to, where they received treatment for at least 4 weeks after the infusion for side effect monitoring.
Accepting help with gratitude
For Karla, one of the hardest parts of treatment was to be cared for by others. However, she was so thankful for the support, especially what she received not long after her infusion.
“Through this, I learned that when people ask if they can do something for you, you accept their help with thanks and gratitude because I know I would do the same thing for someone else.”
It was hard for me to accept it at first. Not anymore. Yes, I need help, and thank you so much!
The results were in
When Karla got her first PET scan after being treated with Breyanzi, she was excited to hear the scans were clear.
When my doctor gave me my results, I was beaming ear to ear. We were so happy.
Now, nearly 2 years after treatment with Breyanzi, Karla is still free from treatments for lymphoma.
While the scans Karla gets every 6 months show that she is in remission, it does not mean she’s cancer free. Karla continues to be monitored for possible disease recurrence and long-term side effects from CAR T cell therapy.
Today, it’s about the little things
Karla says she’s a homebody who loves her home, yard, and doing things with her family. For her, it’s about doing the little things: being with her family and watching them grow and thrive.
I look forward to every little thing I do—every little thing. I'm going to make brownies today. What do you think about that?
—Karla
Karla wants others to talk with their doctor about Breyanzi
Although results will vary from person to person, Karla urges others to talk to their doctors about Breyanzi to see if this treatment approach may be right for them.
Breyanzi gave me so much hope. It opened up a future. And that sounded pretty darn good to me.
See more stories from others treated with Breyanzi
Karla’s Story
"When Breyanzi was given to me as an option, I was unsure. And now that I've done it, I know I did the right thing for me. I'm the living, breathing proof of it. It worked for me."
View StoryBill’s Story
“My wife looked over at me and said, ‘Are you sure you want to do this?’ and I said, ‘Yes.’”
Read MoreDan’s Story
“When I heard about CAR T cell therapy,
I had a lot of faith
and a lot of hope.”
Nick’s Story
“Acknowledge your fears and talk about them, but stay optimistic. Stay open to the possibilities.”
Read MoreDavid’s Story
“You have to hope that there is a chance. That’s what CAR T cell therapy was for me.”
Read More