Breyanzi

What is Breyanzi?

Breyanzi is a treatment for certain kinds of B-cell lymphoma (a kind of cancer that starts with white blood cells) in patients who have cancer that has recurred or is not responding to other treatment options. Breyanzi (lisocabtagene maraleucel) is a medication that is made using cells from the patient's blood. It is a drug that activates your body's immune system (a collection of cells, tissues, and organs that guard the body from attacks by viruses, bacteria, cancer cells, and other substances that cause illness) to fight off cancer cells. Breyanzi is a form of CAR T-cell therapy.

Functions

Breyanzi is used specifically to treat patients suffering from big B-cell lymphoma (LBCL), which includes diffuse B-cell lymphoma (DLBCL) not yet identified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma. The only way Breyanzi can treat you is in the following situations:

• Your first treatment hasn't resulted in a cure, or your cancer has returned within a year after the first treatment.
• The first treatment you tried hasn't resulted in a cure, or you have had cancer return after your first treatment, and you're not qualified for hematopoietic stem cell transplantation due to health conditions or old age.
• Two or more types of treatment haven't worked or have stopped working.

How to take Breyanzi?

Breyanzi is available as an infusion (liquid) that is administered intravenously (into the vein) by a physician or nurse at the office of a doctor or infusion centers. It is typically administered as two injections over a period of between 30 and 60 minutes as an all-in-one dose. Before receiving this medicine, your physician or nurse will also administer other chemotherapy drugs in preparation for Breyanzi treatment.

Prior to the time your dose of Breyanzi is given, A sample of white blood cells from you will be collected at a center for cell collection by a process known as leukapheresis (a procedure that takes out all white blood cells in your body). Since this medication is derived from your own cells, it should only be given to you. It is crucial to be punctual and not fail to attend your scheduled gathering appointment(s) or the time to get your dose of treatment. It is recommended to remain close to the place where the treatment was received. Breyanzi treatment for a minimum of 4 weeks following the dose. Your healthcare provider will review your treatment to make sure that it is effective and be on the lookout for any potential adverse or negative effects. Consult your physician about the best way to prepare for leukapheresis as well as what you can expect before and following the procedure.

Prior to using this drug

Prior to receiving the Breyanzi drug:

• Tell your doctor and pharmacist if you're allergic to Breyanzi, other medications, or any other components in lisocabtagene maraleucel. Talk to your pharmacist or consult the Medication Guide for the list of ingredients.
• Inform your pharmacist and doctor about any other prescription or nonprescription medicines, vitamins, nutritional supplements, or herbal products you're using or are planning to use. Your doctor might need to adjust the dosage of your medication or watch closely for adverse consequences.
• Inform your doctor if you are suffering from or have experienced a hepatitis B viral infection or liver disease.
• Inform your doctor if you are pregnant, planning to be pregnant, or breastfeeding. You'll need an ultrasound pregnancy test before you begin this medication. If you fall pregnant while taking this medication, contact your doctor immediately.

Warnings

Breyanzi can trigger an extremely serious and life-threatening reaction known as cytokine release syndrome (CRS). A nurse or doctor will observe closely during the infusion for at least 4 weeks following. Inform your doctor if you suffer from an inflammatory disorder or suspect that you are suffering from an infection currently. The doctor will prescribe medications 30 to 60 minutes prior to your infusion in order to avoid reactions to maraleucel lisocabtagene. If you notice any of the following symptoms after and during your infusion, inform your physician right away: chills, fever, irregular or fast heartbeats, muscle shaking, diarrhea, weakness, fatigue, difficulty breathing, breath shortness, and confusion. nausea, dizziness, vomiting, or lightheadedness. Breyanzi can cause serious or life-threatening reactions to the central nervous system. These reactions can be experienced following treatment with this medication. Inform your doctor if you've had seizures, strokes, or a loss of memory. If you are experiencing one of these symptoms, inform your doctor right away: headache, dizziness, difficulty sleeping or being able to sleep, restlessness, anxiety, confusion, or uncontrollable shaking in a specific area of the body or mind, agitation, seizures, difficulty standing, or trouble speaking. Bryanzi is available only through a specific, limited distribution plan. The Breyanzi REMS Program (Risk Evaluation and Mitigation Strategy) was created due to the risk of neurological toxicities and CRS. It is only possible to receive the medication through a physician or health care facility that is a participant in the program. Talk to your doctor if you have any questions about the program.

Your pharmacist or doctor will provide you with the patient information sheet from the manufacturer (Medication Guide) before you begin treatment with this medication and every time you fill your prescription. Be sure to read the information thoroughly and consult your physician or pharmacist if you have any concerns.

Cautions

Important safety precautions to be aware of include:

• Breyanzi could make you sleepy and can cause dizziness, confusion, weakness, seizures, and coordination issues. Don't drive or operate machines for at least 8 weeks after the last dose.
• Don't donate organs, blood, or tissues to be transplanted after receiving this medication.
• Consult your physician to determine if you need to get any vaccines. Make sure you do not receive any vaccinations without consulting your physician at least six weeks prior to beginning chemotherapy or during the course of your Breyanzi treatments, and then until your doctor informs you that your immune system is fully recovered.

Side Effects of Breyanzi

Breyanzi could cause adverse effects. Inform your doctor in the event that you experience any symptoms that appear extreme or persist completely.

• Constipation.
• Stomach pain.
• Loss of appetite.
• Rashes.
• Numbness, pain, tingling, burning, or numbness in the hands or feet.

Certain Breyanzi adverse effects could be severe. If you notice any of these symptoms or those mentioned in the warning section, consult your doctor immediately or seek urgent medical attention.

• Feeling tired.
• There may be bleeding or bruising.
• The fever, sore throat, chills, fever, or any other indications of illness.
• Confusion.
• Rapid or irregular heartbeat.

Breyanzi could increase your chance of developing certain types of cancer. Discuss with your physician the risks of taking this drug. This medication could cause additional adverse effects. Contact your physician if you encounter any unusual issues when taking this medication. If you experience a severe adverse reaction or a serious side effect, you or your physician can report it with the FDA's (FDA) MedWatch Adverse Event Reporting program on the internet ([WEB]) or by telephone (1-800-332-1088).

Interaction with other drugs

Other drugs can impact the effectiveness of this medication, such as prescription and non-prescription medications such as vitamins and herbal supplements. It is essential to keep a list of all prescription and non-prescription (over-the-counter) drugs you're using, as well as all products like minerals, vitamins, and other dietary supplements. It is recommended to bring this list along every time you see a doctor or are admitted to an inpatient hospital. It's also important to keep it on hand in the event of an emergency.

To find out if there are interactions with Breyanzi, click the link below.

Further Information

• Schedule appointments with your physician, the cell collection center, and the laboratory. Your doctor might order specific tests for your lab prior to and following your treatment to assess the body's reaction to this medication.
• Before you undergo any test in the laboratory, be sure to inform your doctor as well as the laboratory personnel that you are taking this medication.
• Consult your pharmacist, doctor, or health care provider with any questions you might have regarding Breyanzi.