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.

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IMPORTANT SAFETY INFORMATION

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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.