| Read this Medication Guide before you start your AUCATZYL treatment. The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment. |
| 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 light-headedness
- difficulty breathing
- confusion
- fast or irregular heartbeat
- low blood pressure
- chills/shivering
- shaking or twitching (tremor)
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| 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. |
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 changed (genetically modified) to recognize and attack your leukemic cells. |
Before getting AUCATZYL, tell your healthcare provider about all of 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 medication 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.
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Step 1:
- 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.
- Your infusion dose will be tailored to the burden of your disease. This will be provided as two separate infusions.
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Step 2:
- Before you receive AUCATZYL, your healthcare provider will give you chemotherapy for a few days to make room in the bone marrow.
- When your AUCATZYL is ready, your healthcare provider will give it to you through a catheter (tube) placed into your vein (intravenous infusion).
- After you receive your AUCATZYL first infusion you will receive your second infusion 10 days (± 2 days) later.
- 30 minutes before you are given AUCATZYL, you may be given medicines for fever (such as acetaminophen).
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Step 3:
- After AUCATZYL infusion, you will be monitored daily for at least fourteen days after the infusion so that your healthcare team can closely monitor your recovery.
- You should plan to stay close to the location where you received your treatment for at least four 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.
- 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.
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What should I avoid after receiving AUCATZYL?
- Do not drive, operate heavy machinery, or do other dangerous activities for eight weeks after you get AUCATZYL because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
- Do not donate blood, organs, tissues, or cells for transplantation.
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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 light-headedness, 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 may report side effects to FDA at 1-800-FDA-1088. |
General information about the safe and effective use of AUCATZYL.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about AUCATZYL, talk with your healthcare provider. You can ask your healthcare provider for information about AUCATZYL that is written for health professionals. You can get additional information by contacting Autolus Inc at 1-855-288-5227 or at www.AUCATZYL.com |
What are the ingredients in AUCATZYL?
Active ingredients: obecabtagene autoleucel
Inactive ingredients: albumin (human); DMSO |
| Manufactured by: Autolus Limited, Marshgate, Stevenage, SG1 1FR, United Kingdom. |
| Manufactured for: Autolus Inc., Gaithersburg, MD, 20877 |
| US License No 2339 |
| AUCATZYL is a registered trademark of Autolus Limited. |
| © 2024 Autolus Limited. All Rights Reserved. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: 11/2024 |