Breyanzi
Breyanzi (lisocabtagene maraleucel) is an immunotherapy known as chimeric antigen receptor (CAR) T-cell therapy. It's used to treat adults with certain relapsed or advanced blood cancers, including large B-cell lymphoma (LBCL) and follicular lymphoma (FL). Breyanzi (lisocabtagene maraleucel) treatment is a one-time infusion where your T-cells are collected, changed in a lab, and infused back into your body to fight cancer. The process, including preparation and recovery, can take several weeks and requires a hospital stay for monitoring. Some serious side effects include cytokine release syndrome and neurological symptoms like confusion or headaches.
What is Breyanzi (lisocabtagene maraleucel)?
What is Breyanzi (lisocabtagene maraleucel) used for?
- Relapsed or advanced large B-cell lymphoma (LBCL) in adults, when at least 1 other treatment haven’t worked well
- Relapsed or advanced chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) in adults, when at least 2 previous treatments haven’t worked well, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor
- Relapsed or advanced follicular lymphoma (FL) in adults, when 2 or more previous treatments haven’t worked well
- Relapsed or advanced mantle cell lymphoma (MCL) in adults, when 2 or more previous treatments haven’t worked well, including a BTK inhibitor
How Breyanzi (lisocabtagene maraleucel) works
Your immune system can not only help fight off infections, but certain immune cells (T-cells) can also fight cancer. Sometimes, cancer cells try to hide from the T-cells. So in order for T-cells to work best to fight cancer, they need to tell the difference between healthy and cancer cells.
Breyanzi (lisocabtagene maraleucel) is a type of immunotherapy, also called CAR-T therapy. During treatment, your T-cells are removed from your body and sent to a lab. There, they’re programmed specifically to find and attack cancer cells, such as lymphoma cells, in your body. Once ready, the T-cells are infused back into your body to destroy cancer cells.
Drug facts
More on Breyanzi (lisocabtagene maraleucel) essentials
Side effects of Breyanzi (lisocabtagene maraleucel)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low white blood cell levels (98%)
- Fever (55%)
- Cytokine release syndrome (49%)
- Low platelet levels ( 48%)
- Muscle pain (36%)
- Headache ( 34%)
- Low red blood cell levels (32%)
- Tiredness (28%)
- Nausea (24%)
- Constipation (20%)
- Dizziness (20%)
Note: Side effects listed were reported by people who received Breyanzi for large B-cell lymphoma.
Less Common Side Effects
- Trouble sleeping
- Tremors
- Muscle spasms or weakness
- Diarrhea
- Stomach pain
- Vomiting
- Swelling from fluids
- Infections
- Rash
- Bleeding
Breyanzi (lisocabtagene maraleucel) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome: Fever, trouble breathing, chills, low blood pressure, changes in heart rhythm, headache
- Serious nervous system problems: headache, confusion, difficulty speaking, difficulty writing, seizures
- Serious infection: fever, body aches, fast heartbeat, chills
- Serious bleeding (from low platelets): nosebleeds, blood in urine, blood in stool, bruising that won't go away, bleeding that's difficult to stop, stomach pains
The following Breyanzi (lisocabtagene maraleucel) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Constipation
- Diarrhea
- Dizziness
- Fatigue
- Headache
- Muscle pain
- Nausea
Pros and cons of Breyanzi (lisocabtagene maraleucel)
Pros
- Recommended treatment for certain people with B-cell lymphoma, including those who aren’t able to have a stem cell transplant
- Works in a targeted, more specific way than traditional chemotherapy
- Treatment option for advanced CLL/SLL, FL, and MCL
Cons
- Can cause a serious reaction called cytokine release syndrome
- Treatment requires a multi-step process including blood collection, lymphodepleting chemotherapy, and Breyanzi (lisocabtagene maraleucel) infusion
- Need to stay at and close to treatment facility for weeks after the infusion for monitoring
Pharmacist tips for Breyanzi (lisocabtagene maraleucel)
- After you receive the Breyanzi (lisocabtagene maraleucel) infusion, you’ll need to stay at the treatment center for a week for monitoring. But after this time, you’ll need to stay within 2 hours of the treatment center for at least 4 more weeks so you can continue your check ups. Talk with your caregivers and healthcare team about housing or other logistics needed during this time.
- If you develop a fever before or after receiving Breyanzi (lisocabtagene maraleucel), let your oncology team know right away. If you develop a fever before the infusion, your team might need to postpone treatment until after you recover. And if you develop a fever after the infusion, it might be an early sign of cytokine release syndrome (CRS) or serious infection, and you’ll need medical attention right away.
- Some people receiving Breyanzi (lisocabtagene maraleucel) developed serious infections. You can help prevent infection by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them.
- Even though it’s usually mild, you might experience some nausea during lymphodepleting chemotherapy and Breyanzi (lisocabtagene maraleucel) treatment. Ask your oncology team about anti-nausea medications, such as ondansetron (Zofran) or prochlorperazine (Compazine), to help manage your symptoms.
- It’s unclear whether it’s safe to get live vaccines while preparing for and after receiving Breyanzi (lisocabtagene maraleucel). Live vaccines aren’t recommended starting from at least 6 weeks before lymphodepleting chemotherapy until after your immune system recovers after Breyanzi (lisocabtagene maraleucel) infusion. Ask your oncology team if you’re not sure whether you can receive certain vaccines.
- Breyanzi (lisocabtagene maraleucel) can cause tiredness and nervous system problems. Because of these risks, you shouldn’t drive or handle any type of dangerous machine for 2 months after your treatment. Make sure you have family, friends, or a caregiver to help drive you to and from appointments.
Common questions about Breyanzi (lisocabtagene maraleucel)
Chimeric antigen T-cell therapy, or CAR-T therapy, is a type of immunotherapy used to treat cancer. This treatment uses cells from your own immune system, called T-cells, to attack and kill cancer cells. After collecting T-cells from your blood, a special lab programs the T-cells to attack proteins found on the outside of your cancer cells. The cells are then infused back into your body so they can attack and kill cancer cells. There are many types of CAR-T therapy, and each one programs T-cells to attack proteins specific to the type of cancer you have. Breyanzi (lisocabtagene maraleucel) is used to treat certain types of lymphomas, and so T-cells for this treatment are programmed to attack a protein called CD19. This is because the CD19 protein is found on lymphoma cells.
The most common side effect of Breyanzi (lisocabtagene maraleucel) treatment is low white blood cell (WBC) count. Lymphodepleting chemotherapy might cause your white blood cell levels to drop, and they can stay low for several weeks. Because your WBC typically helps fight infection, you can get sick easier when their levels are low. Your oncology team will check your blood cell counts, including your WBC levels, regularly before and after you receive Breyanzi (lisocabtagene maraleucel). If appropriate, they might prescribe an antibiotic or antiviral medication to protect you from infections. Check your temperature regularly, and call your oncology team right away if you have a fever.
Cytokine release syndrome (CRS) is a serious side effect of CAR-T therapies, including Breyanzi (lisocabtagene maraleucel). It happens when small proteins in your immune system called cytokines overreact to the Breyanzi (lisocabtagene maraleucel) infusion. CRS typically occurs 4-5 days after the infusion, which is why you need to remain at or close to the treatment center for several weeks after you receive treatment. If you have a milder case of CRS, you might experience symptoms like fever, tiredness, or muscle aches. More serious symptoms can include low blood pressure and confusion. Your oncology team can treat mild CRS with fluids and fever medications. But in serious cases, they might need to use medications like corticosteroids and Actemra (tocilizumab). Get medical care right away if you have symptoms of CRS.
Typically, your oncology team will prescribe three days of chemotherapy before you have this Breyanzi (lisocabtagene maraleucel) infusion. This is called lymphodepleting chemotherapy or lymphodepletion, usually with fludarabine and cyclophosphamide. Lymphodepletion is given to help prepare your body for the Breyanzi (lisocabtagene maraleucel) infusion. The chemotherapies dampen the activity of other immune cells in your body, so they don’t attack or remove the Breyanzi (lisocabtagene maraleucel) cells from your body. This helps make sure the Breyanzi (lisocabtagene maraleucel) cells will work better to fight and kill cancer cells.
You should avoid driving or doing any potentially dangerous activities that need a lot of focus for at least 2 months after receiving Breyanzi (lisocabtagene maraleucel) infusion. This is because Breyanzi (lisocabtagene maraleucel) can raise the risk for certain side effects related to the brain and spinal cord, including confusion, tremors, and seizures. These side effects typically appear about a week after the infusion and can last for 2 to 3 weeks, and sometimes longer. These side effects can make it dangerous for you to drive. Before receiving Breyanzi (lisocabtagene maraleucel), it’s important that you and your caregivers have a conversation about transportation and other needs during your recovery period.
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Risks and warnings for Breyanzi (lisocabtagene maraleucel)
Breyanzi (lisocabtagene maraleucel) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
People who receive Breyanzi (lisocabtagene maraleucel) commonly experience an immune reaction called cytokine release syndrome (CRS). The most common symptoms include fever, low blood pressure, fast heartbeat, chills, and headache. Sometimes, CRS can cause serious problems such as heart rhythm changes, heart attack, and serious lung problems. Because CRS typically develops within a week after the Breyanzi (lisocabtagene maraleucel) infusion, your oncologist will monitor you daily for CRS symptoms the week after your infusion. After this time, you’ll need to stay close to the treatment center for at least 4 weeks. This way, if you have CRS symptoms, you can get medical help right away. If you develop CRS, typically you’ll need to stay in the hospital and be treated with corticosteroids and a medication called Actemra (tocilizumab). Because CRS can be life-threatening, get medical help right away if you experience any CRS symptoms, even if it has been many weeks after your infusion.
Breyanzi (lisocabtagene maraleucel) can also trigger another serious hypersensitivity reaction called immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). People have reported this reaction 1-3 weeks after the Breyanzi (lisocabtagene maraleucel) infusion. IEC-SH tends to occur in people who've already been treated for CRS. Your healthcare team will also monitor you for IEC-SH in the weeks after your infusion.
Nervous system problems
Some people taking Breyanzi (lisocabtagene maraleucel) have developed nervous system problems. The more common symptoms include headache, trouble with speech, and tremor. Potentially life-threatening symptoms include seizures and swelling in the brain. Nervous system problems typically develop around 8 days after the Breyanzi (lisocabtagene maraleucel) infusion. Your oncology team will monitor you for symptoms for at least 4 weeks after your treatment. If you have symptoms of nervous system problems, seek medical help right away.
REMS program
Because Breyanzi (lisocabtagene maraleucel) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems, it’s only available through a special program called a Risk Evaluation and Mitigation Strategy (REMS). This program requires your oncology team to complete special training to prescribe Breyanzi (lisocabtagene maraleucel). Additionally, the hospital or treatment center where you receive treatment must keep certain medications used to manage side effects, such as Actemra (tocilizumab), available in case you need it.
Risk of new cancers
Though not common, some people who received Breyanzi (lisocabtagene maraleucel) in clinical trials have developed new cancers, including blood cancers such as myelodysplastic syndrome (MDS). Some of these cancers appeared over a year after their Breyanzi (lisocabtagene maraleucel) infusions. Your oncology team will monitor you for new cancers regularly after Breyanzi (lisocabtagene maraleucel) treatment. Ask your care team if you’re concerned about the risk of cancers from Breyanzi (lisocabtagene maraleucel).
Lower blood cell counts
Breyanzi (lisocabtagene maraleucel) treatment, including the lymphodepleting chemotherapy before T-cell infusion, can lower blood cell counts in your body. This might last longer than a month after the Breyanzi (lisocabtagene maraleucel) infusion. Having lower blood cell counts puts you at higher risk for infections, bleeding, and anemia.
Your oncology team will closely monitor your blood cell counts before and after Breyanzi (lisocabtagene maraleucel) treatment. Make sure you go to all lab appointments so that they can keep a close eye on your blood cell counts.
Serious infections
People who received Breyanzi (lisocabtagene maraleucel) have developed serious and life-threatening infections, including bacterial, viral, and fungal infections. Breyanzi (lisocabtagene maraleucel) can cause your white blood cell (WBC) levels to drop, which can raise your risk for getting sick. People who had hepatitis B in the past might have a new infection (hepatitis B reactivation) after starting Breyanzi (lisocabtagene maraleucel). Your oncology team will monitor your WBC levels with lab tests, and they might prescribe medications, such as antibiotics or antivirals, to help protect you from serious infections.
You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your healthcare team right away if you have any signs or symptoms of infection such as fever, body aches, and chills.
Allergic reactions
It’s possible for you to have an allergic reaction to Breyanzi (lisocabtagene maraleucel), including anaphylaxis. Allergic reactions may be due to dimethyl sulfoxide (DMSO), a preservative in the cell product. Let your nurse or oncologist know right away if you have symptoms of an allergic reaction during or immediately after your infusion, such as itching, trouble breathing, rash, swelling, or fast heartbeat.
Low immunoglobulins
Some people taking Breyanzi (lisocabtagene maraleucel) experienced low immunoglobulin levels. Immunoglobulins are proteins that are an important part of your immune system, and help fight infection. When your immunoglobulins are low, this raises your risk for getting sick.
Your oncology team will monitor your immunoglobulin levels. If they’re too low, you might need to take a medication called intravenous immunoglobulin (IVIG) to replace immunoglobulins in your body.
Risks driving or using machines
Breyanzi (lisocabtagene maraleucel) treatment might cause nervous system changes that can include tiredness, confusion, and seizures. Don’t drive or participate in activities that would be dangerous if you couldn’t focus for 2 months after treatment. Talk with your oncology team and caregivers so that you have a plan in place to help you with transportation to appointments, chores at home, and emotional support, before you start Breyanzi (lisocabtagene maraleucel).
Breyanzi (lisocabtagene maraleucel) dosage
Typical dosage for Breyanzi (lisocabtagene maraleucel)
Breyanzi is usually given at a qualified treatment center or in a hospital setting. The treatment process takes several stages:
- Blood collection: Your immune cells are collected from your body. Your T cells are separated, while the rest of your immune cells are infused back into your body. This process typically takes several hours.
- Making Breyanzi: Your T cells are sent to a lab and made into Breyanzithat’s specific for you. This step takes about 1 month.
- Pre-treatment with chemotherapy: To prepare your body to receive Breyanzi, your oncologist will prescribe 3 days of chemotherapy, typically cyclophosphamide and fludarabine.
- Receiving Breyanzi: About 2-7 days after chemotherapy, your oncologist will infuse Breyanzi into your veins in two back-to-back 15-minute infusions.
After treatment, you’ll need to stay at or near the qualified treatment center for at least 4 weeks so your oncology team can monitor your recovery and check for side effects.
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