Aucatzyl

Aucatzyl is a CAR-T cell treatment for acute lymphoblastic leukemia (ALL) in adults that is made by genetically modifying a person’s white blood cells to recognize and attack leukemic cells. Aucatzyl (obecabtagene autoleucel) is given as 2 infusions, 10 days (± 2 days) apart.

Aucatzyl’s mechanism of action involves first extracting and concentrating the patient’s blood cells, and then sending them to a specialized manufacturing facility where their T cells are genetically modified to express an anti-CD-19 receptor. These T cells are then infused back into the patient where they engage and bind with CD19 expressed on leukemic cells, killing the cell and reducing tumor activity.

Aucatzyl gained FDA approval on November 8, 2024. No REMS is required by the FDA for Aucatzyl.

Aucatzyl is used for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Read the Aucatzyl Medication Guide before you start 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

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.

Also tell your healthcare provider if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

The most common side effects of Aucatzyl are:

• 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, shortness of breath)
• Fast irregular heartbeat
• Confusion
• Difficulty speaking or slurred speech
• Low white blood cells (can occur with a fever)
• Bleeding.

Serious side effects and warnings

Aucatzyl carries a Boxed Warning for Cytokine Release Syndrome, neurologic toxicities, and secondary blood cancers.

Cytokine Release Syndrome (CRS), is a potentially fatal, inflammatory, immune reaction with symptoms that may include fever, headache, joint and muscle pain, low blood pressure, and organ failure in severe cases. Do not have Aucatzyl therapy if you have an active infection or inflammatory disorder.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, has occurred following treatment with Aucatzyl, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Tell your healthcare provider if you experience any neurologic events after Aucatzyl treatment, such as headache, dizziness, tremor, anxiety, sleep disturbances and delirium.

Secondary blood cancers, including myelodysplastic syndrome, acute myeloid leukemia, and T-cell malignancies, are more common in people who have previously received CAR T-cell treatments, such as Aucatzyl.

Aucatzyl may increase the risk of prolonged and/or recurrent cytopenias (low white or red blood cell counts or low platelet levels) associated with bleeding and infection. Your healthcare provider will monitor your blood cell counts.

Aucatzyl can cause allergic reactions in some people. Tell your healthcare provider right away if you experience fever, swelling, a rash, or breathing difficulties.

Aucatzyl may cause drowsiness for several weeks which can affect your ability to drive or operate machinery. Avoid driving for at least 2 weeks after receiving Aucatzyl.

You may be more likely to get an infection, low immunoglobulin levels, or a hyperinflammatory syndrome after treatment with Aucatzyl. 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).

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.

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 Autolus Inc., toll-free phone 1-855-288-5227 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before receiving Aucatzyl, your blood will need to be collected by a process called leukapheresis (loo-kah-fur-ee-sis), which will concentrate your white blood cells and allow Aucatzyl to be made from them.

The following 3 Steps then take place.

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.

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).

Step 3:

• After your Aucatzyl infusion, you will be monitored daily for at least 7 days after the infusion so that your healthcare team can closely monitor your recovery.

• 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.
• 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.

Avoid driving for at least 2 weeks after you get Aucatzyl.

Do not donate blood, organs, tissues, or cells for transplantation.

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

Active ingredients: obecabtagene autoleucel

Inactive ingredients: albumin (human), DMSO

Aucatzyl is a cell suspension for infusion that contains a total recommended dose of 410 x 106 CD19 CAR-positive viable T cells supplied in 3 to 5 infusion bags.

Aucatzyl is made by Autolus Limited in the United Kingdom.