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Managing side effects

Medical staff monitoring patient’s possible side effects of CAR T-cell therapy.

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What are the possible side effects of TECARTUS?

Because TECARTUS is a treatment that works on your immune system, there is a risk that your immune system may become overactive and affect the rest of your body in unwanted ways. You can learn about the possible side effects of TECARTUS by reading the Important Safety Information.

Two side effects that many patients have experienced are Cytokine Release Syndrome (CRS)? and Neurotoxicity?:

CRS and Neurotoxicity can become life-threatening and can lead to death. Call or see your healthcare provider or get emergency help right away if you get any of the following:

  • Fever (100.4°F/38°C or higher)
  • Difficulty breathing
  • Chills or shaking chills
  • Confusion
  • Dizziness or lightheadedness
  • Severe nausea, vomiting, or diarrhea
  • Fast or irregular heartbeat
  • Severe fatigue or weakness

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.

The most common side effects of TECARTUS include:

  • 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

These are not all the possible side effects of TECARTUS. It’s important to talk to your treatment team about how you are feeling, and let them know if you notice any symptoms. Each person's experience and potential side effects will be different.

How will the treatment team manage side effects and keep me safe?

Your safety and care are top priority. There will be multiple safety measures in place throughout your TECARTUS treatment experience:

You will receive TECARTUS at a certified treatment center?. These hospitals are well equipped to deal with serious side effects.

The treatment team at the certified treatment center has extensive experience and specific training in monitoring and treating CAR T side effects. During your time there, you will be in expert hands.

When discharged from the treatment center, you will be given a Patient Wallet Card that contains the contact information of your treatment team. Be sure to carry it with you at all times, and show it to any healthcare providers you have to see.

What is my role in managing side effects?

Both patients and caregivers play an important role during CAR T treatment. See below for what you can do and how your responsibilities may shift throughout treatment.

Remember that you can always ask your treatment team if you have questions about side effects and how to look for them.

During TECARTUS infusion and close monitoring

To help prepare for your CAR T-cell infusion, your treatment team may give you premedications.

You will need to stay at the treatment center for at least 1 week after the infusion for patients with MCL, and 2 weeks after infusion for patients with ALL, in case serious side effects happen. During this time, you will be under the care of your treatment team. Serious side effects are most likely in the first few weeks after infusion.

Your treatment team is well equipped to manage and treat side effects. They will regularly complete health checks? and ask you to do some simple tasks? to identify and track any symptoms. If needed, they may treat CRS or neurotoxicity with corticosteroids or other medications.

A patient with the oncologist and caregiver during TECARTUS® (brexucabtagene autoleucel) infusion at a certified treatment center.

Your treatment team is well equipped to manage and treat side effects. They will regularly complete health checks? and ask you to do some simple tasks? to identify and track any symptoms. If needed, they may treat CRS or neurotoxicity with corticosteroids or other medications.

What you can do

Proactively tell the treatment team if you notice any changes in how you're feeling. Caregivers may be the first to notice side effects, as some symptoms can be difficult for patients to recognize by themselves.

The treatment team can also answer any questions you may have about side effects and how to look for them.

Learn more about what to expect and how to prepare for this step on the Receiving TECARTUS page.

During continued monitoring

When the treatment team feels you are ready, you may be able to leave the treatment center but you will still need to stay nearby so you can return quickly if any side effects occur. Your treatment team will let you know how close you need to stay.

A caregiver closely monitoring a patient while the patient recovers at home.

What you can do

Follow your treatment team's instructions for monitoring for signs and symptoms of side effects. You will be responsible for monitoring side effects once you've left the center. Notify your treatment team immediately if you notice any changes. Receiving medical attention right away may keep side effects from becoming more serious.

You will receive a Patient Wallet Card to carry with you. You will need to show it to any healthcare providers you visit.

“I'm glad we asked lots of questions about what to do and who to call if something happens. We had someone we could call 24/7 during the first 30 days as we transitioned from the treatment center to a temporary apartment close by.”

DavidTECARTUS Patient

This testimonial is representative of the patient’s own experience. Individual treatment results and experience may vary.

David TECARTUS® (brexucabtagene autoleucel) patient ambassador sitting in a chair.

This testimonial is representative of the patient’s own experience. Individual treatment results and experience may vary.

Learn more about what to expect and how to prepare for this step on the Receiving TECARTUS page.

During recovery at home

When the treatment team thinks you are ready—at least 4 weeks after infusion—you'll no longer be required to stay near the treatment center. If you had to travel for treatment, this means you can now return home. You may also start returning to your local oncologist for follow-up appointments.

A patient recovering at home after treatment with continued caregiver support.

What you can do

Continue to look out for side effects and talk to your healthcare teams about how you are feeling. Make sure to attend follow-up appointments. If you miss an appointment, it's important to reschedule as soon as possible.

You should continue carrying the Patient Wallet Card and show it to any healthcare providers you visit.

Learn more about what to expect and how to prepare for this step on the Receiving TECARTUS page.

Have questions? Call us

Your treatment team is the best resource for support throughout treatment.

If you have questions at any step of the CAR T process, our dedicated team at Kite can also help. You can call them at:

1-844-454-KITE [5483]5483
Monday–Friday 8 am–9 pm ET 5 am–6 pm PT
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Cytokine Release Syndrome (CRS)

SY-toh-kine reh-LEES SIN-drome

CRS happens when your immune system becomes overactive.

After infusion, when the modified T cells recognize and kill cancer cells, they may release proteins called cytokines.

A buildup of cytokines can lead to symptoms including:

  • fever
  • chills
  • rapid heart rate
  • low blood pressure
  • low blood oxygen level

CRS typically lasts between 1–2 weeks and typically begins in the first week after infusion, when you are staying at the treatment center under the care of the treatment team.

Neurotoxicity

NOOR-oh-tok-SIH-sih-tee

Neurotoxicity is a side effect that happens when there is damage to the brain and spinal cord.

Neurotoxicity can cause symptoms like:

  • changes in the way the brain functions
  • seizures
  • changes in level of consciousness
  • difficulty with speech
  • tremors
  • confusion

Symptoms of neurotoxicity can last for 2–3 weeks and typically begin around 1 week after TECARTUS infusion.

Some health checks your treatment team might do:

Patient undergoing health checks.
  • Temperature: to check if you have a fever or an elevated temperature (over 100.4ºF or 38ºC)
  • Blood pressure: to check if it is low
  • Oxygen levels: to check if they are low
  • Blood tests: to monitor for infections or any changes in function of internal organs

Certified treatment centers

In order to provide TECARTUS, cancer treatment centers must first be certified. Certified treatment centers have specifically-trained medical staff, strict treatment protocols, and safety measures in place for CAR T-cell therapy. These centers are often first to use best care practices learned through research.

Certified treatment centers are sometimes known as authorized treatment centers.

Approved Uses

TECARTUS is a treatment for adults with mantle cell lymphoma or acute lymphoblastic leukemia ...

Important Safety Information

What is the most important information I should know about TECARTUS? TECARTUS may cause side effects that are life-threatening and can lead to death ...

Approved Uses and Important Safety Information

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Approved Uses

TECARTUS is a treatment for adults with mantle cell lymphoma or acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.

Important Safety Information

What is the most important information I should know about TECARTUS?

TECARTUS may cause side effects that are life-threatening and can lead to death. Call or see your healthcare provider or get emergency help right away if you get any of the following:

  • Fever (100.4°F/38°C or higher)
  • Difficulty breathing
  • Chills or shaking chills
  • Confusion
  • Dizziness or lightheadedness
  • Severe nausea, vomiting, or diarrhea
  • Fast or irregular heartbeat
  • Severe fatigue or weakness

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 getting TECARTUS, tell your healthcare provider about all your medical problems, including if you have or have had:

  • Neurologic problems (such as seizures, stroke, or memory loss)
  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive TECARTUS?

  • Since TECARTUS is made from your own white blood cells, your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
  • Your blood cells will be sent to a manufacturing center to make your TECARTUS.
  • Before you get TECARTUS, you will get 3 days of chemotherapy to prepare your body.
  • When your TECARTUS is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
  • You will be monitored where you received your treatment daily for at least 7 days for patients with MCL and at least 14 days for patients with ALL after the infusion.
  • You should plan to stay close to the location where you received your treatment for at least 4 weeks after getting TECARTUS. Your healthcare provider will help you with any side effects that may occur.
  • You may be hospitalized for side effects. Your healthcare provider will discharge you if your side effects are under control and it is safe for you to leave the hospital.
  • Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving TECARTUS?

  • Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get TECARTUS because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of TECARTUS?

The most common side effects of TECARTUS include:

  • 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

These are not all the possible side effects of TECARTUS. Call your healthcare provider about any side effects that concern you. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Important Facts, including IMPORTANT WARNINGS.

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Some simple tasks your treatment team might ask you to do:

Patient conducting simple task checks with supervision from treatment team.
  • Write something, like a standard sentence
  • Say something, like naming the date and location you are in, pointing to and naming objects in the room, counting backwards from 100 by increments of 10
  • Follow a simple instruction, like holding up two fingers