Tecartus
Tecartus (brexucabtagene autoleucel) is an immunotherapy known as chimeric antigen receptor (CAR) T-cell therapy. It’s used to mantle cell lymphoma (MCL) and acute lymphocytic leukemia (ALL) in adults when other treatments haven’t worked well. Treatment involves taking T-cells from your own body, programming them to better find cancer cells, and then infusing them back to your body so they can fight cancer. The entire treatment process, including preparation and recovery, can take over a month. Tecartus (brexucabtagene autoleucel) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems.
What is Tecartus (brexucabtagene autoleucel)?
What is Tecartus (brexucabtagene autoleucel) used for?
- Advanced mantle cell lymphoma (MCL)
- Advanced B-cell precursor acute lymphocytic leukemia (ALL)
How Tecartus (brexucabtagene autoleucel) works
Your immune system can not only help fight off infections, but certain immune cells (T-cells) can also fight cancer. Sometimes, cancer cells try to hide from the T-cells. So in order for T-cells to work best to fight cancer, they need to tell the difference between healthy and cancer cells.
Tecartus (brexucabtagene autoleucel) is a type of immunotherapy, also called CAR-T therapy. During treatment, your T-cells are removed from your body and sent to a lab. There, they’re programmed specifically to find and attack cancer cells, such as lymphoma or leukemia cells, in your body. Once ready, the T-cells are infused back into your body to destroy cancer cells.
Drug facts
More on Tecartus (brexucabtagene autoleucel) essentials
Side effects of Tecartus (brexucabtagene autoleucel)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low blood cell counts (up to 99%)
- Fever (up to 96%)
- Cytokine release syndrome (up to 92%)
- Lower blood pressure (up to 69%)
- Faster heartbeat (up to 63%)
- Confusion, poor memory, and other symptoms of encephalopathy (63%)
- Tiredness (up to 48%)
- Blood electrolyte changes (up to 47%)
- Infection (43%)
- Chills (up to 41%)
- Nausea (41%)
- Fast breathing, dizziness, and other symptoms of low oxygen levels (40%)
- Tremor (up to 38%)
- Cough (38%)
- Headache (up to 38%)
- Muscle pain (up to 37%)
- Swelling (up to 35%)
Less Common Side Effects
- Diarrhea
- Constipation
- Lower appetite
- Vomiting
- Trouble breathing
- Rash
- Trouble communicating
- Trouble sleeping
Tecartus (brexucabtagene autoleucel) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome: Fever, trouble breathing, dizziness, chills, low blood pressure, fast heartbeat, headache, tiredness
- Serious nervous system problems: headache, confusion, changes in personality, depression, difficulty speaking, difficulty writing, weakness in the arms and legs, tingling in the hands and feet, tremor, slower movement, seizures
- Serious infections: fever, body aches, fast heartbeat, chills
- Bleeding (from low platelets): nosebleeds, blood in urine, blood in stool, unexplained bruising
The following Tecartus (brexucabtagene autoleucel) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Loss of appetite
- Muscle pain
- Nausea
- Swelling of the ankles, hands, or feet
Pros and cons of Tecartus (brexucabtagene autoleucel)
Pros
- Works in a more targeted way than traditional chemotherapy
- Recommended treatment for certain people with mantle cell lymphoma (MCL)
- Given as a one-time treatment
Cons
- Can cause a serious reaction called cytokine release syndrome (CRS)
- Treatment requires a multi-step process that takes over a month
- Can't drive for at least 2 months after the infusion
Pharmacist tips for Tecartus (brexucabtagene autoleucel)
- Your oncology team needs to closely monitor you for several weeks after you receive Tecartus (brexucabtagene autoleucel) because treatment can lead to serious side effects. You'll need to stay close by the treatment center where you received Tecartus (brexucabtagene autoleucel) for at least 3 weeks after your treatment. If needed, ask your healthcare team about how to plan for your stay and recommended places for lodging.
- If you develop a temperature of 100.4 Fahrenheit or higher, seek medical help right away. This means you have a fever. A fever with Tecartus (brexucabtagene autoleucel) can be serious, because it can mean you have an infection or it can be an early sign of cytokine release syndrome (CRS).
- Let your oncology team know right away if you notice symptoms of cytokine release syndrome (CRS), such as chills, fever, tiredness, and trouble breathing. These can happen days after you receive Tecartus (brexucabtagene autoleucel). If you have CRS, your care team will need to give you medical attention right away to prevent life-threatening complications.
- Because Tecartus (brexucabtagene autoleucel) treatment can weaken your immune system, you’re at risk for developing serious infections, even months after your treatment. You can help prevent infection by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them.
- It's unclear how live vaccines might affect Tecartus (brexucabtagene autoleucel) treatment. To be safe, you should avoid getting any live vaccines within 6 weeks of the start of chemotherapy (lymphodepletion). Also, avoid live vaccines until after your immune system has recovered from Tecartus (brexucabtagene autoleucel). Your oncology team will let you know when it’s safe for you to receive live vaccines.
- It's best to avoid driving or doing activities that needs lot of focus and attention for at least 2 months after you receive Tecartus (brexucabtagene autoleucel). This is because Tecartus (brexucabtagene autoleucel) can cause some serious side effects after the infusion, including dizziness and coordination problems. Please work with your caregiver, family, or friends to plan transportation to and from appointments, as well as for help at home during this time.
Common questions about Tecartus (brexucabtagene autoleucel)
Chimeric antigen T-cell therapy, or CAR-T therapy, is a type of immunotherapy used to treat cancer. This treatment uses cells from your own immune system, called T-cells, to attack and kill cancer cells. After collecting T-cells from your blood, a special lab programs the T-cells to attack proteins found on the outside of your cancer cells. Then you’ll take an infusion of the T-cells back into your body, where they can then attack the cancer cells. There are several types of CAR-T therapy, and each one programs T-cells to target proteins specific to the type of cancer you have. Tecartus (brexucabtagene autoleucel) is programmed to attack a specific protein found on MCL or ALL cells.
The Risk Evaluation and Mitigation Strategy (REMS) program is a medication safety program created by the FDA for certain medications that can cause serious side effects. The REMS program gives specific instructions on how to minimize or manage serious side effects of the medications. Tecartus (brexucabtagene autoleucel) is part of the REMS program because it can cause cytokine release syndrome (CRS) and neurotoxicity, which can be life-threatening. As part of Tecartus (brexucabtagene autoleucel) REMS, you can only receive treatment at certified hospitals or clinics, and your oncology team needs to complete training on how to recognize and treat these side effects. Make sure to carry the Tecartus Patient Wallet Card with you at all times and get medical help right away if you notice symptoms of CRS or neurotoxicity, including fever, muscle pain, numbness in the hands and feet, and trouble with memory or movement.
The most common side effect of Tecartus (brexucabtagene autoleucel) treatment is low white blood cell (WBC) count. The low-dose chemotherapy you receive before the Tecartus (brexucabtagene autoleucel) infusion can cause your WBC count to drop. And it can take several weeks to months before your WBC level can recover. When your WBC count is low, you’re at higher risk for infections. If appropriate, your oncology team might recommend you to take an antibiotic or antiviral medication to help protect you from infection. Your care team will check your blood cell counts regularly in the weeks after you receive Tecartus (brexucabtagene autoleucel). Check your temperature regularly, and call your oncology team right away if you have a temperature of 100.4 degrees Fahrenheit or higher. This means you have a fever, which might be a sign of infection.
Yes, Tecartus (brexucabtagene autoleucel) can cause cytokine release syndrome (CRS), which is a serious immune reaction to the medication. This reaction happens when small immune proteins called cytokines overreact to the Tecartus (brexucabtagene autoleucel) infusion and cause problems in your body. Symptoms of CRS can include fever, trouble breathing, tiredness, and low blood pressure. Typically, symptoms appear about a week after Tecartus (brexucabtagene autoleucel) infusion and usually lasts 1 to 2 weeks. Rarely, symptoms can last for several months. Because CRS can be life-threatening, your oncology team will ask you to stay at or close by the treatment center where you received Tecartus (brexucabtagene autoleucel) for at least 3 weeks after the infusion. This is so that they can monitor you regularly for symptoms of CRS and other serious side effects, and if needed, give you treatment as quickly as possible.
You should avoid driving or doing any potentially dangerous activities that need a lot of focus for 2 months after receiving Tecartus (brexucabtagene autoleucel) infusion. This is because Tecartus (brexucabtagene autoleucel) can raise the risk for certain side effects related to the brain and spinal cord, including confusion, tremors, and memory loss. These side effects typically appear about a week after the infusion and can last for several weeks, and sometimes longer. These side effects can make it dangerous for you to drive. Before receiving Tecartus (brexucabtagene autoleucel), it’s important that you and your caregivers have a conversation about transportation and other needs during your recovery period.
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Risks and warnings for Tecartus (brexucabtagene autoleucel)
Tecartus (brexucabtagene autoleucel) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
Cytokine release syndrome (CRS) is a potentially life-threatening immune reaction that the body can have to the Tecartus (brexucabtagene autoleucel) infusion. Most people who experienced CRS had symptoms within the first week after receiving Tecartus (brexucabtagene autoleucel) and symptoms usually lasted for 1-2 weeks. Symptoms of CRS can include fever, tiredness, chills, and trouble breathing. Rarely, people can also develop other serious immune-related reactions such as hemophagocytic lymhohistiocytosis (HLH) or macrophage activation syndrome (MAS). These complications can cause organ damage and are life-threatening.
Your oncologist will monitor you for symptoms for several weeks after your infusion. If you develop symptoms of CRS, get medical help right away. Typically, you’ll need to go to the hospital for treatment with corticosteroids and a medication called Actemra (tocilizumab) to manage it.
Nervous system problems (neurotoxicities)
Tecartus (brexucabtagene autoleucel) can cause nervous system problems. Common symptoms include headache, tremor, and feeling confused. More serious symptoms include trouble speaking or problem understanding others. Symptoms typically appear within the first week of the Tecartus (brexucabtagene autoleucel) infusion and can last for several weeks.
Your oncology team will monitor you for symptoms of nervous system problems closely after you receive Tecartus (brexucabtagene autoleucel). You’ll need to stay at or close to the treatment center for at least 3 weeks after your infusion so you can get regular check ups and receive medical attention if needed.
REMS program
Because Tecartus (brexucabtagene autoleucel) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems, it's only available through a special program called Risk Evaluation and Mitigation Strategy (REMS). Some requirements of this program including ensuring the healthcare facility where you receive treatment to be certified and to keep certain medications used to manage side effects, such as Actemra (tocilizumab), available in case you need it.
Lower blood cell counts
Tecartus (brexucabtagene autoleucel) treatment, including the lymphodepleting chemotherapy before T-cell infusion, can lower blood cell counts in your body. This might last longer than 2 months after the Tecartus (brexucabtagene autoleucel) infusion. Having lower blood cell counts puts you at higher risk for infections, bleeding, and anemia.
Your oncology team will closely monitor your blood cell counts after Tecartus (brexucabtagene autoleucel) treatment. Make sure you go to all lab appointments so that your care team recommends so that they can keep a close eye on your blood cell counts.
Serious infections
People who received Tecartus (brexucabtagene autoleucel) have developed serious and life-threatening infections, including bacterial, viral, and fungal infections. Tecartus (brexucabtagene autoleucel) can cause your white blood cell (WBC) levels to drop, which can raise your risk for getting sick. People who had hepatitis B in the past might have a new infection (hepatitis B reactivation) after starting Tecartus (brexucabtagene autoleucel). Your oncology team will monitor your WBC levels with lab tests, and they might prescribe medications, such as antibiotics or antivirals, to help protect you from serious infections.
You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your healthcare team right away if you have any signs or symptoms of infection such as fever, body aches, and chills.
Risk of new cancers
People who receive Tecartus (brexucabtagene autoleucel) might be at higher risk for developing T-cell-related cancers. Your oncology team will monitor you for new cancers regularly after Tecartus (brexucabtagene autoleucel) treatment. Ask your care team if you’re concerned about the risk of cancers from Tecartus (brexucabtagene autoleucel).
Low immunoglobulins
Some people taking Tecartus (brexucabtagene autoleucel) experienced low immunoglobulin levels. Immunoglobulins are proteins that are an important part of your immune system, and help fight infection. When your immunoglobulins are low, this raises your risk for getting sick.
Your oncology team will monitor your immunoglobulin levels. If they’re too low, you might need to take an antibiotic to protect you from infection, or receive a medication called intravenous immunoglobulin (IVIG) to replace immunoglobulins in your body.
More research is needed to understand how Tecartus (brexucabtagene autoleucel) treatment affects your body’s response to vaccines. Your oncologist will ask you to avoid live vaccines at least 6 weeks before you start low-dose chemotherapy for Tecartus (brexucabtagene autoleucel), until your immune system recovers.
Allergic reaction
People who receive Tecartus (brexucabtagene autoleucel) infusion might experience allergic reactions. You're at higher risk for allergic reactions if you're sensitive to the preservative called dimethyl sulfoxide (DMSO) in the medication or to gentamicin. Tell your nurse right away if you have any symptoms of an allergic reaction during your infusion, such as itching, trouble breathing, rash, swelling, or fast heartbeat.
Risks with driving or using machines
Tecartus (brexucabtagene autoleucel) treatment might cause nervous system changes that can include tiredness, confusion, and seizures. Don’t drive or participate in activities that would be dangerous if you couldn’t focus for 2 months after treatment. Talk with your oncology team and caregivers so that you have a plan in place to help you with transportation to appointments, chores at home, and emotional support, before you start Tecartus (brexucabtagene autoleucel).
Tecartus (brexucabtagene autoleucel) dosage
Typical dosage for Tecartus (brexucabtagene autoleucel)
Tecartus (brexucabtagene autoleucel) is usually given at a qualified treatment center or in a hospital setting. The treatment process takes several stages:
- Blood collection: Your immune cells are collected from your body. Your T cells are separated, while the rest of your immune cells are infused back into your body. This process takes 3 to 4 hours.
- Making Tecartus: Your T-cells are sent to a lab and made into Tecartus that’s specific for you. This step takes about 2-3 weeks.
- Pre-treatment with chemotherapy: To prepare your body to receive Tecartus, your oncologist will prescribe 3 days of chemotherapy, typically cyclophosphamide and fludarabine.
- Receiving Tecartus: Two days (sometimes longer) after last dose of chemotherapy, your oncologist will infuse Tecartus into the vein as a one-time infusion over 30 minutes.
After treatment, you’ll need to stay at or near the qualified treatment center for at least 3 weeks so your oncology team can monitor your recovery and check for side effects.
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