Tecartus (brexucabtagene autoleucel)

What is Tecartus?

Tecartus is a brand-name prescription cell therapy. It’s used to treat mantle cell lymphoma (a rare form of non-Hodgkin lymphoma) in adults.

Tecartus is FDA-approved for mantle cell lymphoma that’s relapsed (come back after past treatment) or refractory (hasn’t improved with other treatment).

Tecartus can only be given by a healthcare professional in a REMS-certified healthcare facility. REMS, which stands for Risk Evaluation and Mitigation Strategies, is a safety program set up by the FDA. It helps make sure that certain treatments are provided safely by specially trained healthcare professionals.

Treatment details

Tecartus is a type of cancer treatment called CAR T-cell therapy. This is a form of immunotherapy (a treatment that stimulates your immune system to attack cancer cells).

Tecartus contains the active ingredient brexucabtagene autoleucel, which is made from your own T cells. T cells are a type of white blood cell that play a key role in your immune system. Tecartus is made by collecting T cells from your blood and altering them in a lab. The altered cells are programmed to find lymphoma cells and help your immune system attack them. The altered cells are then infused back into your blood.

Tecartus is given by intravenous infusion (an injection into a vein that’s given slowly over a period of time). It’s approved as a one-time treatment. Prior to the infusion, you’ll need to have a short course of chemotherapy.

FDA approval

The Food and Drug Administration (FDA) first approved Tecartus for mantle cell lymphoma in 2020. The treatment was granted accelerated approval based on successful results from early clinical studies.

The FDA may grant accelerated approval to treatments for conditions with few effective treatment options. This can speed up access to certain therapies and medications. Full approval may be granted if results from further clinical studies confirm a treatment’s effectiveness.

Effectiveness

For information about the effectiveness of Tecartus, see the “Tecartus uses” section below.

Tecartus generic or biosimilar

Tecartus is a biologic cell therapy that’s available only as a brand-name treatment. Tecartus isn’t available in generic or biosimilar form.

Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. But biologics are treatments made using living cells, so it’s not possible to make exact copies of these. Instead of a generic, biologics sometimes have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. Biosimilars and generics usually cost less than brand-name drugs.

Tecartus is made by collecting your own T cells and altering them in a lab. The active ingredient in Tecartus is called brexucabtagene autoleucel.

Tecartus cost

To learn about the cost of Tecartus, talk with your doctor or insurance company.

Before approving coverage for Tecartus, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the treatment. The insurance company will review the prior authorization request and decide if the treatment will be covered.

If you’re not sure whether you’ll need prior authorization for Tecartus, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Tecartus, or if you need help understanding your insurance coverage, help is available.

Gilead Sciences Inc., the manufacturer of Tecartus, offers a program called Kite Konnect. This program provides various support options, including reimbursement information about Tecartus. For more information and to find out if you’re eligible for support, call 844-454-KITE (844-454-5483) or visit the program website.

Generic or biosimilar version

Tecartus is a biologic cell therapy that’s available only as a brand-name treatment. Tecartus isn’t available in generic or biosimilar form.

Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. But biologics are treatments made using living cells, so it’s not possible to make exact copies of these. Instead of a generic, biologics sometimes have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. Biosimilars and generics usually cost less than brand-name drugs.

Tecartus dosage

Your doctor will determine the best Tecartus dosage to fit your needs.

Therapy forms

Tecartus is a type of immunotherapy called CAR T-cell therapy. Tecartus is made from T cells (a type of white blood cell) that are collected from your blood. The T cells are altered in a lab and then infused back into your blood.

Tecartus is given by intravenous infusion (an injection into a vein that’s given slowly over a period of time).

Dosage for mantle cell lymphoma

Tecartus is given as a one-time treatment.

Your doctor will calculate the dose of Tecartus you need based on your body weight in kilograms. Talk with your doctor if you have questions about what your specific dose will be.

What if I miss my dose?

It’s important to keep your appointment to have your Tecartus infusion. If you miss it, call your doctor’s office right away to reschedule. To help make sure that you don’t miss your appointment, try setting an alarm on your phone.

Will I need to use this therapy long term?

No, Tecartus isn’t meant to be used as a long-term treatment. You’ll have just one Tecartus infusion.

Tecartus side effects

Tecartus can cause mild or serious side effects. The following lists contain some of the key side effects that may occur with Tecartus treatment. These lists do not include all possible side effects.

For more information about the possible side effects of Tecartus, talk with your doctor or pharmacist. They can give you tips about how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Tecartus, you can do so through MedWatch.

Mild side effects

Mild side effects* of Tecartus can include:

• fever
• fatigue (lack of energy)
• minor infections
• cough
• tremor
• headache
• nausea
• fluid retention that causes swelling
• constipation
• diarrhea
• pain in your muscles, bones, or joints
• loss of appetite
• trouble sleeping

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects that Tecartus may cause. To learn about other mild side effects, talk with your doctor or pharmacist, or view the Tecartus medication guide.

Serious side effects

Serious side effects from Tecartus can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Low levels of white blood cells, red blood cells, platelets (blood cells that help form blood clots), or antibodies that may last for more than a few weeks after treatment. Symptoms can include:
  • fever
  • signs of infection, such as a cough or sore throat
  • tiredness
  • gums or nailbeds that are paler than usual
  • shortness of breath
  • bruising easily
  • bleeding, such as nosebleeds or bleeding gums
• Increased risk of developing other cancers.
• Allergic reaction.*
• Cytokine release syndrome.*†
• Neurological toxicities.*†
• Serious infections.*

* For more information about this side effect, see “Side effect details” below.
† Tecartus has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about treatment effects that may be dangerous.

Side effect details

Here’s some detail about certain side effects that this therapy may cause.

Cytokine release syndrome

Tecartus can cause a strong immune reaction called cytokine release syndrome (CRS).* Cytokines are proteins that help pass instructions between cells in your immune system. With CRS, your immune system releases too many cytokines throughout your body, leading to widespread inflammation (swelling and damage).

In clinical studies, CRS was one of the most common side effects reported in people who received Tecartus.

Most cases of CRS happen in the first few days after a Tecartus infusion, but some can develop in the following weeks.

Symptoms of CRS tend to be mild and typically get better within about 10 days. But CRS can sometimes be serious and even life threatening. In rare cases, it may lead to organ failure and can be fatal.

CRS can cause symptoms such as:

• fever
• chills
• severe fatigue (lack of energy) or weakness
• fast heartbeat
• shortness of breath
• dizziness
• nausea
• diarrhea
• headache
• confusion

To find out how often CRS occurred with Tecartus in clinical studies, see the prescribing information. If you have concerns about CRS, talk with your doctor.

* Tecartus has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about treatment effects that may be dangerous.

Monitoring for CRS

After your Tecartus treatment, you’ll stay for at least 7 days in the healthcare facility where you had your infusion. This is so you can be monitored for symptoms of CRS and treated for it if needed.

CRS is treated with a drug called tocilizumab (Actemra). Before you receive Tecartus, the healthcare facility will make sure tocilizumab is available for you in case you need it. If you develop CRS, you may also be given corticosteroids (drugs that reduce inflammation), depending on how severe your symptoms are. In addition, you might receive other supportive treatments until the CRS gets better.

After you leave the facility where you had your Tecartus infusion, you should stay nearby for at least 4 weeks. This is so you can get treatment for CRS if you need it. Other healthcare facilities may not have the right treatments available.

Call your doctor right away if you develop symptoms of CRS. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Neurological toxicity

Tecartus can sometimes cause neurological toxicity (side effects involving the brain or nervous system). These side effects may happen alone. Or they may happen at the same time or after CRS. (For more information about CRS, see the “Cytokine release syndrome” section above.)

In clinical studies, neurological toxicity was one of the most common side effects reported in people who received Tecartus.*

Most cases of neurological toxicity happen in the first few days after a Tecartus infusion. But some can also develop in the following weeks.

Symptoms of neurological toxicity may include:

• headache
• tremor
• sleepiness
• confusion
• disorientation
• trouble speaking or understanding
• seizures

In most cases, symptoms are mild and get better within about 3 weeks. But neurological toxicity can sometimes be serious or life threatening. In rare cases, it can be fatal.

To find out how often neurological toxicity occurred with Tecartus in clinical studies, see the prescribing information. If you have questions about this side effect, talk with your doctor.

* Tecartus has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about treatment effects that may be dangerous.

Monitoring for neurological toxicity

After your Tecartus treatment, you’ll stay for at least 7 days in the healthcare facility where you had your infusion. This is so you can be monitored for symptoms of neurological toxicity and treated for it if needed.

Depending on its severity, neurological toxicity may be treated with supportive care. Or you may be given medications, such as corticosteroids or seizure medications.

After you leave the facility where you had your Tecartus infusion, you should stay nearby for at least 4 weeks. During this time, call your doctor right away if you develop symptoms of neurological toxicity. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious infections

Tecartus treatment can raise your risk for infections. Some infections may be serious or life threatening. These include fungal, bacterial, or viral infections that may spread throughout your body. In clinical studies, infections were one of the most common side effects reported in people who received Tecartus.

Tecartus raises your risk for infections because it lowers the levels of B cells (a type of white blood cell) in your body. B cells usually produce antibodies that help protect you from infections. So Tecartus can also lower your levels of antibodies.

Your total white blood cell count will also be lowered by the short course of chemotherapy you have before your Tecartus infusion. White blood cells usually help your immune system fight germs that can cause infections.

You’ll have an increased risk for infections until your white blood cells and antibodies increase in numbers again. This typically takes about 1 month, but it can take longer in some people.

Symptoms of infections may include:

• fever
• chills
• cough
• sore throat
• diarrhea

To find out how often infections occurred with Tecartus in clinical studies, see the prescribing information. Talk with your doctor if you’d like to know more about your risk for infections with Tecartus.

Monitoring for serious infections

Before you have Tecartus treatment, your doctor may test you for certain infections, such as hepatitis B. If you have an active infection, you typically won’t have Tecartus treatment until the infection clears up. You may need medication to treat the infection.

After you receive Tecartus, you’ll have frequent blood tests to monitor your levels of white blood cells and antibodies. You may be given medication such as antibiotics to help prevent infections. And you might need treatments to improve your white blood cell or antibody levels.

Tell your doctor right away if you get any symptoms of infection after receiving Tecartus. You’ll likely need medication to treat the infection.

To help prevent infections after receiving Tecartus, you should:

• wash your hands or use hand sanitizer frequently, especially if you’ve been in a public place
• avoid crowds when possible
• stay away from people who are sick
• try to have a healthy diet and get enough rest

Allergic reaction

Some people can have an allergic reaction after receiving Tecartus.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Tecartus, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Tecartus uses

The Food and Drug Administration (FDA) approves prescription therapies such as Tecartus to treat certain conditions. Tecartus may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Tecartus for mantle cell lymphoma

Tecartus is FDA-approved to treat mantle cell lymphoma in adults.*

Lymphomas are cancers that start in the lymphatic system, which is part of your immune system. The lymphatic system includes the lymph vessels, lymph nodes (also called lymph glands), spleen, thymus, and tonsils. Your lymph vessels carry a fluid called lymph around your body. Lymph contains white blood cells that help protect your body from infection and disease.

There are two main types of lymphoma, Hodgkin lymphoma and non-Hodgkin lymphoma. Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma.

Mantle cell lymphoma affects white blood cells called B lymphocytes, commonly called B cells. This type of cancer typically starts in the lymph nodes. But it often spreads to the bone marrow, blood, spleen, and intestines. It may cause symptoms such as:

• painless swelling of lymph nodes in your neck, armpit, or groin
• heavy sweating at night
• loss of appetite
• weight loss
• fatigue (lack of energy)
• diarrhea
• belly pain
• nausea and vomiting

Mantle cell lymphoma is often widespread when it’s first diagnosed. It may also be aggressive and difficult to treat. Tecartus is approved for mantle cell lymphoma that’s relapsed (come back after past treatment) or refractory (hasn’t improved with other treatment).

* Tecartus received accelerated approval from the FDA for mantle cell lymphoma. The treatment was granted accelerated approval based on successful results from early clinical studies. The FDA may grant full approval after more clinical studies confirm a treatment’s effectiveness.

Effectiveness for mantle cell lymphoma

Tecartus has been found to be highly effective for treating relapsed or refractory mantle cell lymphoma. It’s included as a treatment option for this type of cancer in guidelines from the National Comprehensive Cancer Network. For information about how the treatment performed in clinical studies, see the prescribing information for Tecartus.

Tecartus and children

Tecartus isn’t approved for use in children. It hasn’t been studied in children, so it’s not known whether it’s safe or effective for them to receive.

Tecartus use with other drugs

Tecartus is used with certain drugs to treat mantle cell lymphoma.

A few days before you have Tecartus, you’ll be given a short course of chemotherapy. Two chemotherapy drugs are used, cyclophosphamide and fludarabine. This chemotherapy lowers the number of white blood cells in your body, which helps make Tecartus more effective.

You’ll be given the chemotherapy by intravenous (IV) infusion on days 5, 4, and 3 before your Tecartus infusion. An IV infusion is an injection into a vein that’s given slowly over a period of time.

About 30 to 60 minutes before you have your Tecartus infusion, you’ll be given drugs to help reduce certain side effects. These drugs are called premedications. You’ll typically be given acetaminophen (Tylenol) and an antihistamine such as diphenhydramine (Benadryl).

If you have questions about the use of drugs with Tecartus treatment, talk with your doctor.

Tecartus and alcohol

Alcohol isn’t known to interact with Tecartus. But if you have certain side effects after receiving Tecartus, drinking alcohol could make these worse. These side effects include headache, dizziness, sleepiness, and diarrhea.

If you drink alcohol, talk with your doctor about how much is safe for you to drink after receiving Tecartus.

Tecartus interactions

Tecartus isn’t known to interact with other medications, supplements, or foods. But it may interact with certain vaccines.

Before starting Tecartus treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about interactions that may affect you, ask your doctor or pharmacist.

Tecartus and vaccines

You shouldn’t get live vaccines for a period of time before and after receiving Tecartus.

Live vaccines contain weakened forms of live bacteria or viruses. These vaccines don’t usually cause infection in people with a healthy immune system. But Tecartus and the chemotherapy you have before it can both weaken your immune system. These treatments lower the levels of white blood cells that fight infections in your body. If you get live vaccines before or after Tecartus, these vaccines could cause serious infections.

You shouldn’t get live vaccines in the 6 weeks before you have your pre-Tecartus chemotherapy. And you shouldn’t get live vaccines after receiving Tecartus until your white blood cell levels have recovered.

Examples of live vaccines include:

• measles, mumps, and rubella (MMR)
• nasal flu spray (FluMist)
• chickenpox
• yellow fever
• rotavirus

If you’re considering getting vaccines before or after receiving Tecartus, talk with your doctor.

How Tecartus is given

You receive Tecartus by intravenous (IV) infusion, which is an injection into a vein that’s given slowly over a period of time. An infusion of Tecartus typically lasts 30 minutes. It’s a one-time treatment.

Tecartus can only be given by a healthcare professional in a REMS-certified healthcare facility. REMS, which stands for Risk Evaluation and Mitigation Strategies, is a program set up by the Food and Drug Administration (FDA). It helps make sure that certain treatments are provided safely by specially trained healthcare professionals.

There are five stages of Tecartus treatment:

1. T-cell collection. The first stage is to have some of your T cells collected at a healthcare facility. These will be used to make Tecartus. Your blood will be passed through a machine that separates out your T cells. This process is called leukapheresis, and it takes about 3 to 4 hours.
2. T-cell modification. Your T cells are sent to a lab where they’re programmed to find lymphoma cells. This can take 2 to 3 weeks.
3. Pretreatment chemotherapy. When your T cells are ready, you’ll be given low-dose chemotherapy by IV infusion on days 5, 4, and 3 before your Tecartus infusion. The chemotherapy lowers the number of white blood cells in your body, which helps make Tecartus more effective.
4. Tecartus treatment day. You’ll take medication 30 to 60 minutes before your Tecartus infusion. This is called premedication. You’ll typically take acetaminophen (Tylenol) and an antihistamine such as diphenhydramine (Benadryl). Then you’ll be given Tecartus by IV infusion over 30 minutes.
5. Monitoring. After your infusion, you’ll be monitored for possible side effects. For this purpose, you’ll stay at the healthcare facility where you received Tecartus for at least 7 days. After you leave the facility, you’ll need to stay nearby for at least the next 4 weeks. This is so you can go back to the facility if you develop any side effects. To learn about possible side effects of Tecartus, see the “Tecartus side effects” section above.

How Tecartus works

Tecartus is used to treat mantle cell lymphoma that’s relapsed (come back after past treatment) or refractory (hasn’t improved with other treatment).

What happens with mantle cell lymphoma

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma. Lymphomas are cancers that start in the lymphatic system, which is part of your immune system. The lymphatic system contains white blood cells that help protect your body from infection and disease.

With mantle cell lymphoma, white blood cells called B cells become cancerous and don’t work properly. The cancerous B cells multiply and increase in number faster than healthy white blood cells.

What Tecartus does

Tecartus helps your immune system find and destroy the cancerous B cells. It’s a type of cancer treatment called chimeric antigen receptor T-cell therapy (CAR T-cell therapy).

Tecartus is made from your own T cells. T cells are another type of white blood cell that play a key role in your immune system. Tecartus is made by collecting T cells from your blood and altering them in a lab.

In the lab, a harmless virus is used to insert a small piece of genetic code into your T cells. The code programs the T cells to make a particular protein on their surface. This protein is called a chimeric antigen receptor. It allows the T cells to recognize and attach to a protein called CD19. The CD19 protein is found on the surface of cancerous and healthy B cells.

Large amounts of altered T cells are created in the lab. These are then infused back into your blood as a one-time treatment. When they attach to CD19 proteins, they send signals that activate your immune system to attack and kill the cancerous B cells.

How long does it take to work?

Tecartus starts working as soon as you have the infusion. It may take a few weeks before you notice an improvement in your symptoms. But in clinical studies, many people achieved full or partial remission within 1 month after the infusion. Full remission means that the cancer is undetectable. With partial remission, the cancer is much reduced.

Results may vary. Talk with your doctor about what you might expect from Tecartus treatment.

Tecartus and pregnancy

You shouldn’t receive Tecartus if you’re pregnant. This treatment hasn’t been studied during pregnancy. But based on the way Tecartus works, it’s likely to be harmful to a developing fetus.

If you can become pregnant, you’ll have a pregnancy test before receiving Tecartus. This is so that your doctor can be sure you’re not pregnant before giving you this treatment.

If you’re pregnant or plan to become pregnant, your doctor will recommend a treatment other than Tecartus.

Tecartus and birth control

You shouldn’t receive Tecartus if you’re pregnant. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs before and after receiving Tecartus.

For more information about having Tecartus treatment during pregnancy, see the “Tecartus and pregnancy” section above.

Tecartus and breastfeeding

It’s not known if Tecartus gets into breast milk or if it can affect a child who is breastfed. If you’re breastfeeding or plan to breastfeed, talk with your doctor about the best way to feed your child after receiving Tecartus.

Common questions about Tecartus

Here are answers to some frequently asked questions about Tecartus.

Is Tecartus a chemotherapy drug?

No, Tecartus isn’t a chemotherapy drug. It’s a type of cancer treatment called CAR T-cell therapy. This is a form of immunotherapy (a treatment that stimulates your immune system to attack cancer cells).

Although Tecartus isn’t a chemotherapy drug, you will have chemotherapy as part of Tecartus treatment. Chemotherapy kills all cells in your body, such as cancer cells, that are multiplying rapidly.

Tecartus is made by collecting T cells (a type of white blood cell) from your blood and altering them in a lab. The altered cells are programmed to find lymphoma cells and help your immune system attack them.

When your altered cells are ready, you’ll have 3 days of low-dose chemotherapy before the altered cells are infused back into your blood. The chemotherapy lowers the numbers of white blood cells in your body, which helps make Tecartus more effective.

Do I need to be monitored or avoid anything after receiving Tecartus?

Yes, you will need to be monitored. Tecartus can sometimes cause serious side effects. For this reason, you’ll be monitored for at least 7 days after your infusion in the healthcare facility where you received Tecartus. This way, if you need any treatment, it can be given right away.

You’ll also need to stay near the healthcare facility for at least 4 weeks after you’ve left it. This is so you can get treatment for side effects if needed. Specialized treatments for Tecartus side effects may not be available in other healthcare facilities.

Side effects you’ll be monitored for include:

• cytokine release syndrome
• neurological toxicity
• low blood cell counts
• low antibody levels

For more information about these side effects, see the “Tecartus side effects” section above.

After receiving Tecartus, your doctor will also monitor you for signs of cancer. They’ll check to make sure Tecartus is working for your lymphoma. They’ll also check for signs of any other cancers. Tecartus may increase your risk for developing a secondary cancer.

The manufacturer of Tecartus is still collecting information about possible side effects of this treatment. If you are diagnosed with a secondary cancer after receiving Tecartus, you can report it to the manufacturer at 844-454-KITE (844-454-5483).

Tecartus can sometimes cause side effects that may affect your ability to drive or operate machines safely. For example, it could cause sleepiness, confusion, weakness, or coordination problems. For this reason, you should avoid activities such as driving or operating heavy machines for 8 weeks after having your Tecartus infusion.

Will I be able to donate blood or organs after I’ve used Tecartus?

No. After receiving Tecartus, you shouldn’t donate blood, organs, tissues, or cells for transplant.

Your altered T cells may be in the blood or tissue you donate. These cells could attack healthy cells in the person receiving your donation. They could also cause serious side effects such as cytokine release syndrome (CRS) in the other recipient. (See “Tecartus side effects” above to read more about CRS.)