Brexucabtagene autoleucel is an immunotherapy medicine used to treat mantle cell lymphoma in adults. brexucabtagene autoleucel is given after other treatments did not work or have stopped working.

Brexucabtagene autoleucel is made using white blood cells removed from blood that is drawn from your body through a vein.

Brexucabtagene autoleucel may also be used for purposes not listed in this medication guide.

A common but serious side effect of brexucabtagene autoleucel is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Brexucabtagene autoleucel is available only at an authorized hospital or clinic, and must be given by specially trained healthcare professionals.

Brexucabtagene autoleucel is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis).

During leukapheresis, some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood.

The cells are then sent to a laboratory where they are made into brexucabtagene autoleucel. Because it will take time to process your blood cells into brexucabtagene autoleucel, you will not receive the medicine on the same day your blood cells are drawn.

Beginning 5 days before brexucabtagene autoleucel is given, you will be pre-treated with chemotherapy to help prepare your body for brexucabtagene autoleucel.

About 30 to 60 minutes before you receive brexucabtagene autoleucel, you will be given other medications to help prevent serious side effects or allergic reaction.

Once your body is ready to receive brexucabtagene autoleucel, your care providers will inject the medicine as an infusion into a vein.

Your doctor will need to check your progress on a daily basis for at least 7 days after the infusion.

For at least 4 weeks, plan to stay near the hospital or clinic where you received brexucabtagene autoleucel.

Brexucabtagene autoleucel affects your immune system. You may get infections more easily, even serious or fatal infections.

If you've ever had hepatitis B, using brexucabtagene autoleucel can cause this virus to become active or get worse. You may need frequent liver function tests.

Brexucabtagene autoleucel can have long lasting effects on your body. You may need frequent medical tests while using this medicine and for a short time after your last dose.

Usual Adult Dose for Lymphoma:

PRETREATMENT: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV on each of the fifth, fourth, and third days before infusing this drug.

Each single infusion bag contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL; the dose is 2 x 10(6) CAR-positive viable T cells/kg, with a maximum of 2 x 10(8) CAR-positive viable T cells

Comments:
-Premedicate with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to infusing this drug.
-Avoid prophylactic use of systemic corticosteroids as it may interfere with the activity of this drug.

Use: For the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)

You should not be treated with this medicine while you have an active infection (such as fever, chills, flu-like symptoms).

Tell your doctor if you have ever had:

• an active or chronic infection;

• a stroke;

• a seizure;

• memory problems;

• breathing problems;

• hepatitis B or C;

• HIV;

• heart problems;

• liver disease;

• kidney disease; or

• if you have received a vaccine within the past 6 weeks.

Using brexucabtagene autoleucel may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

Tell your doctor if you are pregnant. Brexucabtagene autoleucel may harm an unborn baby. Use effective birth control to prevent pregnancy. Talk with your doctor if you plan to become pregnant after you are treated with this medicine.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your pre-treatment chemotherapy. The timing of your chemotherapy and brexucabtagene autoleucel injection is very important to the success of your treatment for mantle cell lymphoma.

Since brexucabtagene autoleucel is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with brexucabtagene autoleucel.

Ask your doctor before you receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Do not donate blood, organs, tissues, or cells for transplantation.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Brexucabtagene autoleucel may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness;

• trouble speaking or writing;

• trouble with daily activities;

• a seizure;

• severe ongoing nausea, vomiting, or diarrhea;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats.

You may need to be treated in a hospital if you have certain side effects.

Common side effects of brexucabtagene autoleucel may include:

• slurred speech;

• fever, chills, cough, or other signs of infection;

• feeling tired or light-headed;

• fast or irregular heartbeats;

• tremor, problems with speech or muscle movement;

• headache, muscle or joint pain;

• nausea, loss of appetite;

• diarrhea, constipation;

• swelling, kidney problems;

• rash; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect brexucabtagene autoleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.