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.
David’s Breyanzi® story
David’s Breyanzi® story
You have to have hope that there is a
chance. That’s what CAR T cell therapy
was for me.
—David
The ultimate battle
The last thing David expected to hear on the other end of the phone line was that he had cancer. A feeling of utter devastation took over when he found out he had diffuse large B-cell lymphoma (DLBCL).
It was difficult to convey the news to my family because there was a lot that I
didn’t know and little that I did know.
When talking to his doctor about what treatment would be like, the prognosis didn’t look good. His doctor told him that the chances of beating his cancer weren’t in his favor. Determined to fight those odds, David went into fighting mode.
Being a Seattle native and lover of sports, David looked to his favorite team, the Seattle Seahawks, for inspiration on perseverance and maintaining a positive mindset. A mindset that he’d depend on.
He promised himself that he would do everything he could to fight the disease.
Every month I’d draw strength from my online community; after sharing my own inspirational message, I would sign my posts with Seahawks-inspired quotes of strength and positive mentality as a reminder to myself and others that I wasn’t about to give up.
The letdowns
Over the next couple of years, David went through multiple rounds of chemotherapy, 3 episodes of radiation, and 4 lumbar punctures before his doctor gave him the news of being in “full metabolic remission.”
I’d cycle between sick days and sicker days, I couldn’t even walk around the block or up the stairs because I was so weak. So, when my doctor told me the news, I didn’t really know what it meant. All I heard was ‘full’ and ‘remission.’ I was thrilled.
Unfortunately, that feeling didn’t last long. After receiving a bone marrow biopsy, he quickly deflated after hearing the results—he still had cancer in his marrow.
Determined not to fall prey to a negative mindset, David looked for next steps. “I was always committed to pressing on. I prayed for the strength to keep going,” he says.
An allogeneic stem cell transplant was David’s next option. “We couldn’t find a donor right away,” says David, “so I was on maintenance medications to help me tread water while a transplant could be lined up.”
After months of waiting, a donor was finally found, and the transplant was scheduled. Two weeks out from the procedure, David went in for a scan, which revealed 2 new tumors. The location of the tumors proved to be an obstacle for the transplant to move forward. David could no longer go through with the procedure.
I was too diseased. Finding out that the transplant fell through, well, it was some of the worst news of my life.
The knocks kept coming
When I couldn’t get the transplant because of the tumors, I didn’t know what my options were. Where could I turn? I was scared and at one of my lowest points.
The only option remaining was to use radiation in an attempt to reduce the tumors enough for an autologous transplant, a procedure David’s doctors warned was risky. David agreed to the plan and, once recovered enough, was finally able to get his stem cell transplant. After spending 28 days in the hospital and weeks of hoping for positive results, David had reached remission.
I was hoping that would be the end of my treatment. But, after a couple of months, the transplant failed—I started to feel the tumors coming back in my armpits, and knew that couldn’t be good news.
Feeling like he already knew what was going on, David went in for a scan. Sure enough, he was right. “My cancer was stronger than I gave it credit for.”
David’s doctors were at a point where they didn’t have a clear treatment direction left for him. “David was pretty much out of options. He’d been given about 6 months to live if he didn’t have another treatment,” says Audrey, David’s wife. His doctor gave him the option of foregoing further treatment, conceding to the cancer, and living his remaining days as comfortably as possible. “Conceding” was not in David’s vocabulary. He told his doctor that he still had too much to live for and would continue the fight.
Never give up
I wanted to keep fighting. It was fear of dying, but it was also a renewal of faith and confidence. I was 58 years old and my kids were still in high school. There was no way I was going to give up when there was still too much to do in my life.
Because David had received at least 2 previous treatments that didn't work or stopped working, the doctor called David and told him about a clinical trial for CAR T cell therapy, now known as Breyanzi. David was very interested in learning more. They went over the procedure and talked about potential serious side effects of Breyanzi that can be life-threatening and can lead to death, such as 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.
See additional Breyanzi Important Safety Information.
With few options remaining, David believed that Breyanzi would be right for him. “I promised to try everything possible, and while I understood the risks, the alternative was giving in to cancer in palliative care.”
When the doctor called and told David that he was accepted into the clinical trial for Breyanzi, we were incredibly excited to get started. He was running out of options, and we really felt like CAR T cell therapy was the right choice for David.
—Audrey, wife and care partner
About 4 weeks after apheresis, David received his Breyanzi cells and found that the day of infusion wasn’t as long as he thought it would be. “Two vials in, and then I was sent to recover,” says David. After getting a low-grade fever, David was admitted to the hospital for almost a week to be treated for cytokine release syndrome. Side effects like cytokine release syndrome and neurologic toxicity can be life-threatening and can lead to death. Because of the risk of cytokine release syndrome, neurologic toxicity, and other side effects, patients like David must remain at, or close to, where they received treatment for at least 4 weeks after the infusion for side effect monitoring.
A few weeks later, when it came time to receive his scans, David’s results came back clean. “At the first clean scan at the end of 1 month, my doctor told me there were too little data to form any clear conclusions,” David said. After the second clean scan another month later, David asked the doctor what that meant. David said that his doctor responded, “Well, 2 clean scans are better than 1!”
David was getting better as 2 clean scans turned to 3, then 4, and his scans continued to remain clear.
I was overjoyed once David went into remission again because we had been given a pretty dire prognosis before that, and the fact that he had repeated clean scans was amazing.
—Audrey, wife and care partner
While David’s scans were clean, they do not mean he’s cancer-free. David continues to be monitored for possible disease recurrence and long-term side effects from CAR T cell therapy.
Life as we know it
David believes that his faith had a part to do with his recovery. It instilled confidence in him, and that confidence was shown to his doctors and those around him. There was a commitment to keep fighting.
David is going to ball games and traveling with his family on vacations. “I felt better after the infusion,” he says.
I feel indebted to Bristol Myers Squibb because
CAR T cell therapy is why I’m here today, living day to day.
If there is one thing David wants others to know, it’s to commit yourself to pursue every reasonable opportunity to get better.
Hopefully it never gets so bad that you lose all hope. Have confidence in your doctors, in your treatment plan, and in yourself.
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