Tecartus is a genetically modified T cell immunotherapy medicine.

Tecartus is used to treat mantle cell lymphoma in adults. 

Tecartus is also used to treat acute lymphoblastic leukemia in adults.

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

This medicine is given after other treatments did not work or have stopped working.

A common but serious side effect of Tecartus 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.

It is important to tell your healthcare provider that you received Tecartus and to show them your Tecartus Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

Before taking this medicine

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

To make sure Tecartus is safe for you, 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 Tecartus 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 Tecartus. Ask your doctor about any risk.

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

Tecartus 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 this medicine is given, you will be pre-treated with chemotherapy to help prepare your body for Tecartus.

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

Once your body is ready to receive Tecartus, 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 Tecartus.

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

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

Tecartus 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.

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

To make sure Tecartus is safe for you, 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 Tecartus 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 Tecartus. 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 Tecartus injection is very important to the success of your treatment for mantle cell lymphoma.

Since this medicine 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 Tecartus.

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 to Tecartus: 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.

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 Tecartus side effects 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 interact with 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.