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.
Dan and Jodi’s Breyanzi® story
Dan was part of the Breyanzi clinical trial and the FDA approved Breyanzi for use after a patient’s second treatment in June 2022.
Dan and Jodi’s Breyanzi® story
When I heard about CAR T cell therapy,
I had a lot of faith
and a lot of hope.
—Jodi, wife and care partner
An unforgettable day
One summer day, Jodi wheeled her husband Dan into a Boston hospital to receive CAR T cell therapy. They didn’t know what to expect. But they did know that diffuse large B-cell lymphoma (DLBCL) was spreading through Dan’s body, and they had to do something.
A feeling washed over the couple as they settled in for their stay. It was going to be okay. Later, their nurse would write something on the whiteboard in Dan’s room.
“Day One”—two words Dan and Jodi will never forget.
“Danny and I have known each other for 30 years, and we’ve been married for nine,” Jodi says. “But that day truly was our day one.”
Three months to live
A few years earlier, Dan worked in construction and Jodi in human resources. Life was good. They had bought a boat—something cheap, just to see if they liked it. They did.
Though Boston had been home for years, the couple started dreaming of a bigger boat and a longer adventure.
Dan had always been healthy. Ever since he started building homes as a teenager, Dan had never even taken a sick day—until a mysterious lump on his neck led to a diagnosis of DLBCL.
The diagnosis didn’t slow him down at first. For 3 years, Dan and Jodi watched and waited. But then Dan started feeling tired and short of breath.
Tests revealed a tumor wrapped around his small intestine. Dan started chemotherapy at their community hospital. Six rounds was the plan, but after 3, scans showed the chemo wasn’t working.
At that point, our only hope was getting into a trial.
After consulting more specialists, Dan started a more aggressive chemo and planned for a stem cell transplant. The doctors had already harvested Dan’s stem cells and were ready to go forward with a transplant when a scan showed his tumor was still growing.
The doctors gave Dan 2 or 3 months to live.
“At that point, our only hope was getting into a trial,” Jodi says. At the time, she worked for a company that did genomic testing, so they tested Dan’s tumor. It looked like immunotherapy could be an option, and the couple was referred to a doctor at a major healthcare center in Boston.
A promising treatment option
Because Dan had received at least 2 previous treatments that didn't work or stopped working, the specialist told Jodi and Dan about a trial for a CAR T cell therapy, now approved as Breyanzi, which would be made from Dan’s T cells (a type of white blood cell) to help fight the cancer.
“I had never heard of CAR T cell therapy, but after the doctor explained it, I said, ‘That’s what I’d like to have,’” Dan says. “I liked the idea that you’re using your own reprogrammed white blood cells to help fight the cancer.”
Dan asked to get on the hospital’s waiting list. His doctor replied, “You already are.”
I liked the idea that you’re using your own white blood cells to help fight the cancer.
In the meantime, Dan and Jodi considered the risks. They learned about the potential side effects of Breyanzi that are life-threatening and can lead to death, including cytokine release syndrome and neurologic toxicity, as well as other common side effects, including fever, low white or red blood cells, severe diarrhea, or severe nausea. But Dan and Jodi felt Breyanzi would be the right option for him.
See additional Breyanzi Important Safety Information.
“In my mind, what was my choice? I knew I might not make it if we didn’t do something. We had to go for it,” Dan says.
Fortunately, he didn’t have to wait long. He rose to the top of the list, and soon, Dan’s T cells were collected through a process called leukapheresis. For 4 weeks, Jodi and Dan went to the hospital 3 to 4 days a week for transfusions, infusions, and salvage chemo—trying to keep Dan alive so he could receive his CAR T cell therapy.
By this time, the always healthy Dan could only walk 12 to 15 feet before having to rest for 10 minutes. Jodi was worried, but Dan, as always, put a smile on her face.
“Danny has this amazing attitude, and I think we laughed every day throughout the horrible journey,” she says. “We were able to find some good in every single day.”
For Dan, it was just his way of life.
“You’ve got to keep a positive attitude,” he says.
Day One: Infusion Day
One day, they got the call: “Your T cells are coming.”
After 3 days of tests, bloodwork, scans, and lymphodepletion chemo to make sure he was ready, Dan was admitted to the hospital for his CAR T cell treatment.
“The nurse came into my room and spent hours setting up every possible contingency. When the doctor finally came in, the infusion took less than a half hour,” Dan says.
As the CAR T cells entered his body, Dan and Jodi held on to hope, the words “Day One” written on the whiteboard nearby.
In the days following his infusion, Dan remained in the hospital for monitoring and treatment for Breyanzi side effects. Ten days later, he managed to walk from the hospital to the car. He had to remain close to the hospital for at least 4 weeks, for continued monitoring for potentially serious side effects, but 1 month later, PET scans revealed that Dan was in remission. Because of the risk of cytokine release syndrome, neurologic toxicity, and other side effects, patients like Dan must remain at, or close to, where they received treatment for at least 4 weeks after the infusion for side effect monitoring.
“When we saw the scans, everyone was so happy for Danny, which was incredible,” Jodi says. “I was crying my eyes out in gratitude.”
While the scans showed that Dan was in remission, it does not mean he's cancer-free. Dan continues to be monitored for possible disease recurrence and long-term side effects from CAR T cell therapy.
The Great Loop
Dan finally bought his dream boat—a 43-foot power catamaran. He and Jodi spent any chance they could familiarizing themselves with the boat and the East Coast. Then, after retiring, they took off on their dream adventure, the Great Loop.
They started in Florida, sailing up the East Coast to the Hudson River and Erie Canal, through the Great Lakes, down the Illinois and Mississippi rivers, across the Gulf, and back to Florida.
10,000 miles, countless memories, and friendships to last a lifetime.
Dan had always wanted to do this. We know how lucky we are. We say it every single day.
—Jodi, wife and care partner
Now that they’ve returned home, their days are filled with family, friends—and their young granddaughter. They continue living each day to the fullest.
Like each day is Day One.
What appeals to me about CAR T cell therapy is using your own cells to fight the cancer.
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