AUCATZYL is a treatment for adults with acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment. AUCATZYL is a medicine made from your own white blood cells, which have been genetically modified to recognize and attack your leukemic cells.

Frequently Asked Questions

The power to spark remission starts with knowledge

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Whether you are considering AUCATZYL, starting treatment, or have already received treatment, it’s totally normal to have questions. Below are several commonly asked questions and answers about relapsed or refractory B‑cell acute lymphoblastic leukemia (B‑ALL) and the AUCATZYL treatment journey.

Understanding AUCATZYL

For those considering AUCATZYL—learn about what it is, how it works, and whether it may be right for you.

  • “Relapsed” means you may have achieved remission after your last treatment, but your leukemia has returned
  • “Refractory” means your leukemia did not get better with your previous treatment and you have not achieved remission
  • B‑ALL, B‑cell acute lymphoblastic leukemia, is a type of leukemia in which too many B‑cells are produced in your bone marrow

Your B‑ALL could be considered relapsed or refractory even if you’ve only received one type of treatment to date.

CAR (or chimeric antigen receptor) T‑cell therapy is a type of cancer treatment that uses your own T cells, a type of white blood cell that fights infections and cancers. CAR T‑cell therapy takes your T cells and turns them into CAR T cells, which are designed to better recognize and attack cancer cells. Then, they are put back into your body, where they can fight your leukemia.

When receiving a CAR T‑cell therapy such as AUCATZYL, there are multiple steps in the process:

  1. Your T cells are collected from your blood.
    This is called leukapheresis. During this process, a machine separates out certain immune cells, including T cells, and then the rest of your blood is returned to your body.
  2. Your T cells are turned into CAR T cells in a specialized laboratory.
    In this step, anti‑cancer receptors called CARs are added to turn your T cells into CAR T cells. They are then multiplied to increase them in numbers.
  3. Your body is prepared to receive the CAR T cells with chemotherapy.
    This reduces the number of the T cells already in the body so that AUCATZYL CAR T cells have the best chance to grow and fight the cancer.
  4. You receive the CAR T cells through an infusion.
    For AUCATZYL specifically, this is done in 2 doses.
  5. You are monitored for side effects that may occur.
    Some side effects may not appear immediately, which is why your doctor will monitor you for 2 weeks after each infusion, so you may need to stay near a medical center during this time.

AUCATZYL is a CAR T‑cell therapy that boosts your immune system to help fight leukemia. Your cells are collected, modified, and then infused into your body in 2 doses.

  • Your blood is collected through a process called leukapheresis
  • It is sent to a manufacturing facility, where your cells are re‑programmed into AUCATZYL CAR T cells
  • You then receive AUCATZYL in 2 doses via intravenous (IV) infusion

AUCATZYL is designed to work by modifying your own immune cells to better target and attack leukemia cells.

When your T cells are transformed into CAR T cells, special “hooks” (called chimeric antigen receptors, or CARs) are added to your T cells.

With these hooks, AUCATZYL targets, attaches to, and fights the leukemia cells in your body.

AUCATZYL may be an option for you whether you were in remission but your leukemia came back, or your last treatment didn’t fully get rid of your leukemia.

  • AUCATZYL is for adults (individuals older than 18 years old)
  • There is no upper age limit to take AUCATZYL
  • AUCATZYL may be an option for you if you have already received other treatments, including stem cell transplant
  • AUCATZYL may be right for you whether or not you have extramedullary disease (your cancer cells also appear outside of the bone marrow)

Yes, AUCATZYL can be taken whether you’ve had one or more therapy for your leukemia before—including whether you’ve had stem cell transplant.

There is no one path to AUCATZYL. No matter which treatment you have tried before, if your leukemia is still present or has come back, AUCATZYL may be an option for you.

AUCATZYL is only intended for use in adults aged 18+. There is no upper age limit to take AUCATZYL.

The treatment process

Whether you’re about to start or have already started AUCATZYL, this information outlines the steps involved in your treatment.

AUCATZYL is a 2‑dose treatment. There are 6 key steps in the treatment of AUCATZYL:

  1. Your blood is collected in a process called leukapheresis. A machine separates your immune cells and the rest of your blood cells are returned to your body.
  2. Your cells are sent to a specialized lab, where anti‑cancer receptors are attached to them to turn them into AUCATZYL. During this time, your doctor may give you another treatment to help stabilize your cancer while your AUCATZYL is being made.
  3. One to two (1‑2) weeks before your first dose, you will have a bone marrow biopsy to assess the level of leukemia cells in your bone marrow. Each person’s AUCATZYL dose is customized based on their level of leukemia cells, and these test results will provide your doctor with the needed information to determine the correct dose of AUCATZYL for you.
  4. You will receive chemotherapy within 7 days after your bone marrow test to make room for your AUCATZYL CAR T cells.
  5. Your first dose: this will be given 3 days after your chemotherapy is finished.
  6. Your second dose: this will be given about 10 days after your first dose.

After each AUCATZYL infusion, your healthcare team will monitor you for at least 2 weeks and manage any side effects that may occur. It will be important that you remain near the healthcare center so your care team can quickly provide you with any support needed, should you experience side effects.

Be sure to ask your care team about your specific monitoring schedule and requirements for after your AUCATZYL infusion.

Chemotherapy helps prepare your body for AUCATZYL. It reduces the number of the T cells already existing in the body, so that AUCATZYL CAR T cells have the best chance to grow and fight the cancer.

Leukapheresis is a process in which your blood is drawn. A machine will separate out certain immune cells, including T cells, and then the rest of your blood is returned to your body.

The timing may vary. In the clinical trial, it took 17 to 23 days from leukapheresis for AUCATZYL manufacturing to be finished and shipped back to the patients’ doctors. Your doctor will schedule your AUCATZYL dose on the day that is right for you.

In the meantime, your doctor may prescribe other treatments to stabilize your cancer (known as “bridging therapy”) before you receive AUCATZYL.

In the manufacturing process, special “hooks” called CARs (chimeric antigen receptors) are added to your T cells. These hooks are designed to help them connect to leukemia cells and fight your cancer.

During this process, your CAR T cells will multiply until they reach the number needed for your AUCATZYL dose.

Last, they are put through a series of rigorous quality control tests before they are sent to your doctor to be given to you.

AUCATZYL is given in 2 doses, which is designed to reduce the risk of certain side effects.

Your dose is designed specifically for you: if you have more leukemia cells in your body, you are at a higher risk of side effects, so you are given a lower first dose of AUCATZYL.

You will be monitored for potentially serious side effects daily for at least 7 days following each infusion.

You should plan to stay near a healthcare facility for at least 2 weeks after each infusion (~4 weeks total).

Your healthcare team will organize your monitoring schedule for during and after this time.

Logistics

Here are some helpful details to help you and your loved ones prepare for your treatment.

Going through any cancer treatment can be a stressful ordeal, and having a caregiver can help you emotionally—but your caregiver also plays an important role in protecting your health.

As with all cancer therapies, there are risks of side effects when taking AUCATZYL. Your caregiver is essential support in the case of side effects. Your caregiver should be able to contact your doctor on your behalf and drive you to and from the treatment center.

You may want to bring comfortable clothing, personal items, and any devices you may need to the treatment center. Your healthcare team may provide a specific checklist.

You will need to avoid driving for at least 2 weeks following each infusion of AUCATZYL.

You will not need to stay in the treatment center after leukapheresis. Your doctor will monitor you closely after your AUCATZYL infusion and will advise on if you can leave the treatment center between doses.

You will need to stay near the treatment center for 2 weeks following each infusion, in case of serious side effects that may occur after your AUCATZYL treatment.

If you live far from the treatment center and have nowhere nearby to stay, you may need to stay in a hotel for the monitoring period. If you have concerns regarding cost, you can contact a Case Manager from AutolusAssist®, who can answer questions regarding support resources that may be available to you.

It is important to tell your healthcare providers that you received AUCATZYL. You will be given an AUCATZYL Wallet Card, which you can show your doctor to help them better understand what AUCATZYL is and what they should know about it. Your doctor may give you other medicines to treat possible side effects.

Safety and side effects

It’s important to understand all the risks involved in your treatment.

Two important safety risks of AUCATZYL are cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS). These are 2 serious side effects that are common with CAR T‑cell therapies, including AUCATZYL.

Call or see your doctor right away if you experience any of the following:

  • Fever (100.4°F/38°C or higher)
  • Severe nausea, vomiting, diarrhea
  • Severe headache
  • Dizziness or light-headedness
  • Difficulty breathing
  • Confusion
  • Fast or irregular heartbeat
  • Low blood pressure
  • Chills/shivering
  • Shaking or twitching (tremor)

The most common side effects of AUCATZYL include:

  • Fever (100.4°F/38°C or higher)
  • Nausea
  • Diarrhea
  • Infections
  • Headache
  • Muscle or joint pain
  • Fatigue or feeling very tired
  • Low blood pressure (dizziness or lightheadedness, headache, fatigue, short of breath)
  • Fast irregular heartbeat
  • Confusion
  • Difficulty speaking or slurred speech
  • Low white blood cells (can occur with a fever)
  • Bleeding

AUCATZYL may reduce the levels of your healthy immune cells in addition to killing the cancer cells in your body. Because of this, you may be at increased risk of infections.

It is important to tell your doctor if you have a recent or active infection before treatment.

Cytokine release syndrome, or CRS, is a side effect possible when taking some B‑ALL treatments, including AUCATZYL. It happens when T cells release proteins called cytokines that send the immune system into overdrive. In the clinical trial, 3% of people receiving AUCATZYL experienced a severe case of CRS.

Symptoms of CRS include fever, chills, trouble breathing, nausea, vomiting, diarrhea, muscle or joint pain, and feeling dizzy. Call your doctor immediately if you have any of these symptoms in the days or weeks after receiving AUCATZYL.

ICANS, or immune effector cell‑associated neurotoxicity syndrome, is a serious and life‑threatening potential side effect of CAR T‑cell therapy. Symptoms include headache, confusion, seizure, shaking, trouble speaking, and loss of balance.

In the clinical trial, 7% of people receiving AUCATZYL experienced a severe case of ICANS. Call your doctor immediately if you have any of these symptoms in the days or weeks after receiving AUCATZYL.

Some side effects may not appear immediately, which is why your doctor will be monitoring you for 2 weeks after each infusion, and why you need to stay near the treatment center during this time.

  • In the clinical trial, half of the patients who experienced CRS started showing symptoms within 6 days after the first infusion, with their CRS lasting approximately 5 days
  • In the clinical trial, half of the patients who experienced ICANS started showing symptoms within 8 days after the first infusion, with their ICANS lasting approximately 9 days

After treatment

Have you received your second dose of AUCATZYL and have questions about what’s next?

AUCATZYL cells can remain in your body for months, even years, continuing to help your immune system fight leukemia.

In laboratory studies, AUCATZYL cells were found to multiply and persist. And in some cases, they were seen to stay in the body for up to 37 months.

Everybody’s recovery time looks different, and your ability to return to normal activities may vary. You should do what feels right for your body and be sure to consult with your doctor.

However, you should avoid driving for 2 weeks after you receive AUCATZYL.

You should not donate blood, organs, tissues, or cells for transplantation after receiving AUCATZYL.

There’s no one answer about how long AUCATZYL may take to work, as everyone may experience results differently.

Within the first 3 months, about 4 in 10 people had a complete remission (CR), which means that the percentage of leukemia cells was below 5% and there were no more signs and symptoms of B‑ALL.

Within or after 3 months, more than 60% had an overall complete remission (OCR). OCR is very similar to CR: it means the percentage of leukemia cells in the body is below 5% and there are no more signs and symptoms of B‑ALL; however, some blood tests still may not be completely normal.

Your doctor will monitor you at regular intervals, even if you are in remission. It’s important to stick to your doctor’s follow‑up schedule.

Support and resources

Everyone needs help sometimes. Learn about resources that may be available to you.

Yes, AutolusAssist® is a convenient way to find valuable resources and dedicated support throughout the treatment journey.

Live support is available each time you call: a Case Manager is ready to answer questions that you may have about insurance, AUCATZYL CAR T‑cell treatment, and support resources.

Contact a Case Manager 24/7 by phone at (855) 288‑5227, or visit AutolusAssist.com.

If you have concerns about the cost of AUCATZYL, contact an AutolusAssist Case Manager, who may be able to determine if there are resources that could help you afford your treatment.

Contact a Case Manager 24/7 by phone at (855) 288‑5227, or visit AutolusAssist.com.

For some people, there may be resources available to help you find a place to stay during your treatment.

Ask your healthcare team if their institution helps patients find a place to stay, and be sure to reach out to an AutolusAssist Case Manager 24/7 by phone at (855) 288‑5227, or visit AutolusAssist.com for more information about resources that may be available.

There are many national organizations for people like you who are fighting B‑ALL and other leukemias. These groups provide a range of support offerings, including psychological and emotional support, financial support, nutritional tips, and community support, to help you connect with other people who share your experience.

Learn more at aucatzyl.com/support or autolusassist.com/patients‑and‑caregivers.

For caregivers

In leukemia care, the role of caregiver is very important. You are supporting your loved one as they go through their hardest battles, and you’re sure to have questions.

As a caregiver, you are your loved one’s first line of support throughout their treatment. This may look different for everyone.

Side effects may occur, so it will be important for you to monitor your loved one for side effects. See the next question for more information about which symptoms you should be watching out for.

Additionally, your loved one should avoid driving for at least 2 weeks after each infusion. You will be needed to help transport them to and from appointments.

Last but not least importantly, your loved one may rely on you for helping with everyday tasks or for emotional support.

Cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS) are 2 serious side effects that are common with CAR T‑cell therapies, including AUCATZYL.

Call or have your loved one see a doctor right away if your loved one experiences any of the following:

  • Fever (100.4°F/38°C or higher)
  • Severe nausea, vomiting, diarrhea
  • Severe headache
  • Dizziness or light-headedness
  • Difficulty breathing
  • Confusion
  • Fast or irregular heartbeat
  • Low blood pressure
  • Chills/shivering
  • Shaking or twitching (tremor)

If your loved one is experiencing any of the side effects below, call or have them see a doctor right away:

  • Fever (100.4°F/38°C or higher)
  • Severe nausea, vomiting, diarrhea
  • Severe headache
  • Dizziness or light-headedness
  • Difficulty breathing
  • Confusion
  • Fast or irregular heartbeat
  • Low blood pressure
  • Chills/shivering
  • Shaking or twitching (tremor)

Yes, caregiver support resources are available through organizations and patient support programs.

Find a list of these resources at aucatzyl.com/support and autolusassist.com/patients‑and‑caregivers.

IMPORTANT SAFETY INFORMATION

MORE

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

AUCATZYL 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)
  • Severe nausea, vomiting, diarrhea
  • Severe headache
  • Dizziness or lightheadedness
  • Difficulty breathing
  • Confusion
  • Fast or irregular heartbeat
  • Low blood pressure
  • Chills/shivering
  • Shaking or twitching (tremor)

What is AUCATZYL®

AUCATZYL is a treatment for adults with acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment. AUCATZYL is a medicine made from your own white blood cells, which have been genetically modified to recognize and attack your leukemic cells.

IMPORTANT SAFETY INFORMATION

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

AUCATZYL 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)
  • Severe nausea, vomiting, diarrhea
  • Severe headache
  • Dizziness or lightheadedness
  • Difficulty breathing
  • Confusion
  • Fast or irregular heartbeat
  • Low blood pressure
  • Chills/shivering
  • Shaking or twitching (tremor)

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

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

  • Neurologic problems (such as seizures, stroke, new or worsening memory loss)
  • Lung or breathing problems
  • Heart problems
  • A recent or active infection
  • Past infections which can be reactivated following treatment with AUCATZYL
  • Pregnancy, you think you may be pregnant, or plan to become pregnant
  • Breastfeeding

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

How will I receive AUCATZYL?

  • AUCATZYL is made from your own white blood cells, so 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 AUCATZYL.
  • While waiting for AUCATZYL to be made, you may get other medicines to stabilize your cancer. This is so that your acute lymphoblastic leukemia does not get worse.
  • Within 7 days before you start treatment, a sample of your cells will be taken to confirm your disease burden, this will determine which infusion dose you are given first.
  • Before you receive AUCATZYL, your healthcare provider will give you chemotherapy to prepare your body.
  • When your AUCATZYL is ready, your healthcare provider will give it to you through a catheter (tube) placed into your vein (intravenous infusion).
  • After AUCATZYL infusion, you will be monitored daily for at least 7 days after the first infusion
  • You should plan to stay close to a healthcare facility for at least 2 weeks after getting AUCATZYL. Your healthcare provider will help you with any side effects that may occur.
  • You may be hospitalized for side effects. Your healthcare provider will determine when you can go home.
  • You will receive your second infusion of AUCATZYL 8‑12 days after the first infusion
  • Your healthcare provider will need to do blood tests to follow your progress. These blood tests are important. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving AUCATZYL?

  • Avoid driving for at least 2 weeks after you get AUCATZYL.
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible side effects of AUCATZYL?

  • The most common side effects of AUCATZYL include:
  • Fever (100.4°F/38°C or higher)
  • Nausea
  • Diarrhea
  • Infections
  • Headache
  • Muscle or joint pain
  • Fatigue or feeling very tired
  • Low blood pressure (dizziness or lightheadedness, headache, fatigue, short of breath
  • Fast irregular heartbeat
  • Confusion
  • Difficulty speaking or slurred speech
  • Low white blood cells (can occur with a fever)
  • Bleeding

AUCATZYL may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

These are not all the side effects of AUCATZYL. 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 full Prescribing Information, including BOXED WARNING and Medication Guide.

What is AUCATZYL®

AUCATZYL is a treatment for adults with acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment. AUCATZYL is a medicine made from your own white blood cells, which have been genetically modified to recognize and attack your leukemic cells.

IMPORTANT SAFETY INFORMATION

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

AUCATZYL 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)
  • Severe nausea, vomiting, diarrhea
  • Severe headache
  • Dizziness or lightheadedness
  • Difficulty breathing
  • Confusion
  • Fast or irregular heartbeat
  • Low blood pressure
  • Chills/shivering
  • Shaking or twitching (tremor)

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

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

  • Neurologic problems (such as seizures, stroke, new or worsening memory loss)
  • Lung or breathing problems
  • Heart problems
  • A recent or active infection
  • Past infections which can be reactivated following treatment with AUCATZYL
  • Pregnancy, you think you may be pregnant, or plan to become pregnant
  • Breastfeeding

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

How will I receive AUCATZYL?

  • AUCATZYL is made from your own white blood cells, so 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 AUCATZYL.
  • While waiting for AUCATZYL to be made, you may get other medicines to stabilize your cancer. This is so that your acute lymphoblastic leukemia does not get worse.
  • Within 7 days before you start treatment, a sample of your cells will be taken to confirm your disease burden, this will determine which infusion dose you are given first.
  • Before you receive AUCATZYL, your healthcare provider will give you chemotherapy to prepare your body.
  • When your AUCATZYL is ready, your healthcare provider will give it to you through a catheter (tube) placed into your vein (intravenous infusion).
  • After AUCATZYL infusion, you will be monitored daily for at least 7 days after the first infusion
  • You should plan to stay close to a healthcare facility for at least 2 weeks after getting AUCATZYL. Your healthcare provider will help you with any side effects that may occur.
  • You may be hospitalized for side effects. Your healthcare provider will determine when you can go home.
  • You will receive your second infusion of AUCATZYL 8‑12 days after the first infusion
  • Your healthcare provider will need to do blood tests to follow your progress. These blood tests are important. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving AUCATZYL?

  • Avoid driving for at least 2 weeks after you get AUCATZYL.
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible side effects of AUCATZYL?

  • The most common side effects of AUCATZYL include:
  • Fever (100.4°F/38°C or higher)
  • Nausea
  • Diarrhea
  • Infections
  • Headache
  • Muscle or joint pain
  • Fatigue or feeling very tired
  • Low blood pressure (dizziness or lightheadedness, headache, fatigue, short of breath
  • Fast irregular heartbeat
  • Confusion
  • Difficulty speaking or slurred speech
  • Low white blood cells (can occur with a fever)
  • Bleeding

AUCATZYL may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

These are not all the side effects of AUCATZYL. 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 full Prescribing Information, including BOXED WARNING and Medication Guide.