Breyanzi is used to treat certain types of large B-cell lymphoma (a type of cancer that begins in the white blood cells) in adults whose cancer has returned or is unresponsive to other treatments. Breyanzi (lisocabtagene maraleucel) is a medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells. Breyanzi is a type of CAR T-cell therapy.

What is Breyanzi used for?

Breyanzi is specifically used to treat adults that have large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. You can only be treated with Breyanzi if:

• 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 may cause a serious or life-threatening reaction called cytokine release syndrome (CRS).A doctor or nurse will monitor you carefully during your infusion and for at least 4 weeks afterwards. Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions to lisocabtagene maraleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, fast or irregular heartbeat, muscle pain, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.

Breyanzi may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with this medicine. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

Bryanzi is only available through a special restricted distribution program. A Breyanzi REMS program (Risk Evaluation and Mitigation Strategy) has been set up because of the risks of CRS and neurological toxicities. You can only receive the medication from a doctor and healthcare facility that participates in the program. Ask your doctor if you have any questions about this program.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with this medicine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. The medication guide is available here on Breyanzi Professional Information.

Special Precautions

Important precautions that you should be aware of are:

• that Breyanzi may make you drowsy and cause confusion, weakness, dizziness, seizures, and coordination problems. Do not drive a car or operate machinery for at least 8 weeks after your last dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive this medicine.
• check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your Breyanzi treatment, and until your doctor tells you that your immune system has recovered.

Breyanzi comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a doctor's office or infusion center. It is usually given as two infusions over a total period of up to 30 minutes as a one-time dose. Before you receive this medicine your doctor or nurse will administer other chemotherapy medications to prepare your body for Breyanzi treatment.

Before your dose of Breyanzi is to be given, a sample of your white blood cells will be taken at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). Because this medication is made from your own cells, it must be given only to you. It is important to be on time and not miss your scheduled cell collection appointment(s) or to receive your treatment dose. You should plan to stay near where you received your Breyanzi treatment for at least 4 weeks after your dose.

Your healthcare provider will check to see if your treatment is working and monitor you for any possible side effects. Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure.

Before receiving Breyanzi:

• tell your doctor and pharmacist if you are allergic to Breyanzi, any other medications, or any of the ingredients in lisocabtagene maraleucel. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had hepatitis B virus or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You will need to have a pregnancy test before you start this medicine If you become pregnant while receiving this medicine call your doctor immediately.

Breyanzi may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• stomach pain
• loss of appetite
• rash
• numbness, pain, tingling, or burning feeling in feet or hands

Some Breyanzi side effects can be serious. If you experience any of these symptoms or those listed in the Warning section, call your doctor immediately or get emergency medical treatment:

• feeling tired
• bruising or bleeding
• fever, sore throat, chills, or other signs of infection
• confusion
• fast or irregular heartbeat.

Breyanzi may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication. This medication may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ([WEB]) or by phone (1-800-332-1088).

Other drugs may affect this medicine , including prescription and over-the-counter medicines, vitamins, and herbal products. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

To check for interactions with Breyanzi click on the link below.