Pronunciation: tek-ahr-tuhs
Generic name: brexucabtagene autoleucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 1, 2025.

What is Tecartus?

Tecartus is used to treat relapsed or refractory mantle cell lymphoma (MCL) or B-cell precursor acute lymphoblastic leukemia in adults.

• The approval for MCL is under accelerated approval based on the overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Tecartus is a personalized cancer treatment called CAR T-cell therapy that is made from your T-cells and is given as a one-time intravenous infusion over 30 minutes. You may receive chemotherapy for a few days before you receive Tecartus, to prepare your body for the infusion.

Tecartus is created through a process called leukapheresis, where physicians extract T-cells from your blood, which are then transported to a specialized facility. At this facility, the T-cells undergo genetic modification to incorporate a chimeric antigen receptor (CAR). This modification enhances the T-cells' capacity to recognize and bind to cancer cells expressing the CD19 protein. After binding occurs, the modified T-cells destroy the cancer cells, thereby boosting the patient's immune response against the disease. 

Tecartus (brexucabtagene autoleucel) gained FDA approval on July 24, 2020, and is made by Kite Pharma, Inc. There is no generic.

Warnings

The Tecartus product label carries a Boxed Warning for cytokine release syndrome, neurologic toxicities, and secondary blood cancers.

Cytokine Release Syndrome (CRS): A potentially life-threatening condition where the immune system overreacts and releases excessive amounts of cytokines, leading to widespread inflammation and organ dysfunction. Tell your healthcare provider immediately if you develop symptoms such as fever, low blood pressure, trouble breathing, or vomiting. Talk to your healthcare provider about having medication available to quickly treat this condition. 

Brain/Nervous System Effects: The treatment can cause confusion, seizures, difficulty speaking, or other brain problems. These neurological symptoms can be serious or fatal.

T Cell Cancer Risk: Rarely, the modified immune cells used in treatment can themselves become cancerous, creating a new type of blood cancer different from the original disease being treated.

It is important to tell all of your healthcare providers that you have received Tecartus.

Side effects

The most common side effects of Tecartus are:

• fever (100.4°F/38°C or higher)
• low white blood cells (can occur with a fever)
• low red blood cells
• low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
• fast heartbeat
• confusion
• difficulty speaking or slurred speech
• nausea
• diarrhea.

Get emergency medical help if you have signs of an allergic reaction to Tecartus such as hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

• 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.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

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

• 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 risks.

How is Tecartus given?

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 reactions.

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.

Dosing information

Dosing of Tecartus is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.

Dose of Tecartus for Mantle Cell Lymphoma (MCL) in adults:

• 2 × 10⁶ CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10⁸ CAR-positive viable T cells.

Dose of Tecartus for B-cell precursor Acute Lymphoblastic Leukemia (ALL) in adults:

• 1 x 10⁶ CAR-positive viable T cells per kg body weight, with a maximum of 1 x 10⁸ CAR-positive viable T cells.

What happens if I miss a dose?

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.

What should I avoid after receiving Tecartus?

Avoid driving for at least 2 weeks after you get Tecartus.

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

What other drugs will affect Tecartus?

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.

Ingredients

Active ingredients: brexucabtagene autoleucel.
Inactive ingredients: albumin (human); DMSO.

Tecartus is available as a cell suspension for infusion.

• MCL: Comprises a suspension of 2 × 10⁶ CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10⁸ CAR-positive viable T cells in approximately 68 mL.
• ALL: Comprises a suspension of 1 x 10⁶ CAR-positive viable T cells per kg body weight, with a maximum of 1 x 10⁸ CAR-positive viable T cells in approximately 68 mL.

Manufacturer

Tecartus is made by Kite Pharma, Inc., Santa Monica, CA 90404.

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Further information

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