AUCATZYL

AUCATZYL is an FDA-registered drug product whose active ingredient is OBECABTAGENE AUTOLEUCEL. It is labelled by Autolus Inc. and marketed as a cellular therapy product. Identifiers on file: NDC 83047-410, application BLA125813, label effective 20260623. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing OBECABTAGENE AUTOLEUCEL are most often described in connection with: treatment adults, relapsed refractory, b-cell precursor, acute lymphoblastic, usage aucatzyl, directed genetically, modified autologous, cell immunotherapy. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ( 1 ).

2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter ( 2.4 ). Prior to infusion Administer a lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. ( 2.3 ). Ensure availability of bone marrow assessment results from a sample obtained within 7 days prior to start of lymphodepleting chemotherapy ( 2.3 ). Premedicate with acetaminophen ( 2.3 ). Confirm availability of tocilizumab prior to infusion ( 2.3 ). AUCATZYL Dose and Administration Verify patient's identity prior to infusion ( 2.3 ). Dosing is based on the Dose Schedule Planner ( 2.3 ). The total recommended dose of AUCATZYL is 410 × 10 6 CD19 chimeric antigen receptor (CAR)-positive viable T cells ( 2.1 ). The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10 (± 2 days) ( 2.1 ). Dose to be administered is determined by the patient bone marrow blast assessment. See Full Prescribing Information for important preparation and administration information ( 2.3 , 2.4 ). 2.1 Dose For autologous use only. For intravenous use only. Strictly follow Administration instructions to minimize dosing errors [see Overdosage (10) ] . The total recommended dose of AUCATZYL is 410 × 10 6 CD19 chimeric antigen receptor (CAR)-positive viable T cells supplied in three to five infusion bags. Bags are supplied in three color-coded bag configurations (10 × 10 6 , 100 × 10 6 , 300 × 10 6 ) for split dose administration. Table 1: AUCATZYL Infusion Bag Configurations CAR-positive T Cell Dose (Bag Configuration) Color Code Volume Fully Infused 10 × 10 6 Blue 10 mL No (See Section 2.3 ) 100 × 10 6 Orange Variable Yes 300 × 10 6 Red Variable Yes The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10 (± 2 days), see Figure 1 and Figure 3 . The dosage regimen will be determined by the tumor burden assessed by bone marrow blast percentage from a sample obtained within 7 days prior to the start of lymphodepletion [see Dosing and Administration (2.3 , 2.4) , Figure 1 and Figure 3 ] . See the Release for Infusion certificate and Dose Schedule Planner for the actual cell counts and volumes to be infused and to select the appropriate dosage regimen [see Dosage and Administration (2.4) and Dosage Forms and Strengths (3) ] . 2.2 Dosage Modification for Adverse Reactions Table 2: Dosage Modifications Intended to Reduce the Risk of Adverse Reactions Adverse Event Severity 1. Based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening. Actions Second Split Dose Day 10 (± 2 days) Cytokine Release Syndrome following the first split dose [see Warnings and Precautions (5.1) ]. Grade 2 Consider postponing AUCATZYL infusion up to Day 21 to allow for the CRS to resolve to Grade ≤ 1. Grade ≥ 3 Discontinue treatment. Immune Effector Cell-associated Neurotoxicity Syndrome following the first split dose [see Warnings and Precautions (5.2) ]. Grade 1 Consider postponing AUCATZYL infusion up to Day 21 to allow for the ICANS to completely resolve. Grade ≥ 2 Discontinue treatment. Pulmonary or cardiac toxicities following the first split dose. Grade ≥ 3 Discontinue treatment. Severe intercurrent infection at the time of AUCATZYL infusion [see Warnings and Precautions (5.4) ]. Grade ≥ 3 Consider postponing AUCATZYL infusion up to Day 21 until the severe intercurrent infection is considered controlled. Requirement for supplementary oxygen. Grade ≥ 3 Consider postponing AUCATZYL treatment up to Day 21 to allow for the adverse reaction to resolve. Other clinically relevant adverse reactions following the first split dose [see Warnings and Precautions (5) ]. Grade ≥ 3 Consider postponing AUCATZYL infusion up to Day 21 to allow for the adverse reaction to resolve. 2.3 Administration AUCATZYL is for autologous use only. The patient's identity must match the patient identifiers on the AUCATZYL infusion bag. Do not infuse AUCATZYL if the information on the patient-specific label does not match the intended patient. Preparing the Patient for AUCATZYL Infusion Bone marrow assessment A bone marrow assessment must be available from a sample obtained within 7 days prior to the commencement of the lymphodepleting chemotherapy treatment, see Figure 1 . Figure 1: AUCATZYL Treatment Schedule The bone marrow assessment will be used to determine the AUCATZYL dosage regimen based on a Bone Marrow Blast of > 20% or ≤ 20%, see Figure 3 . If the bone marrow assessment results are inconclusive: – Repeat biopsy or aspirate, NOTE a repeat biopsy or aspirate is only possible if lymphodepleting chemotherapy treatment has not started. – If results remain inconclusive, proceed with the Bone Marrow Blast of > 20% (i.e., administration of the 10 × 10 6 dose on Day 1) per the AUCATZYL Dose Schedule Planner. An image of the treatment schedule. A bone marrow assessment will be performed 7-13 days prior to administration of Dose 1 of AUCATZYL. Following the bone marrow assessment, six days prior to administration of Dose 1 of AUCATZYL, fludarabine will be administered for four days and cyclophosphamide will be administered for two days starting with the first dose of fludarabine. Dose 1 of AUCATZYL will be administered three days after lymphodepleting chemotherapy treatment (Day 1) and Dose 2 of AUCATZYL will be administered 8-12 days after administration of Dose 1. Pretreatment Confirm availability of AUCATZYL prior to starting the lymphodepleting chemotherapy treatment. Administer the lymphodepleting chemotherapy regimen before infusion of AUCATZYL: fludarabine (FLU) 30 mg/m 2 /day intravenously (IV) for four days and cyclophosphamide (CY) 500 mg/m 2 /day IV for two days starting with the first dose of fludarabine. (total dose: FLU 120 mg/m 2 ; CY 1000 mg/m 2 ), see Figure 1 . Infuse AUCATZYL 3 days (± 1 day) after completion of lymphodepleting chemotherapy treatment (Day 1), allowing a minimum 48-hour washout. Delay AUCATZYL treatment if the patient is experiencing severe intercurrent infection. If the patient requires supplementary oxygen AUCATZYL should only be infused if considered appropriate based on the treating physician's benefit/risk assessment. A delay to the second split dose may be required to manage toxicities [see Dosage Modification for Adverse Reactions (2.2) and Warnings and Precautions (5) ] . Premedication To minimize the risk of an infusion reaction, premedicate with acetaminophen approximately 30 minutes prior to AUCATZYL infusion. Avoid prophylactic use of systemic corticosteroids as they may interfere with the activity of AUCATZYL. Receipt and storage of AUCATZYL AUCATZYL is supplied directly to the cellular therapy laboratory associated with the infusion center in the vapor phase of a liquid nitrogen shipper [see How Supplied/Storage and Handling (16) ] . Confirm the patient's identity on the infusion bags with the patient identifiers on the shipper, see Figure 2 . Figure 2: Patient Specific Identifiers Keep the infusion bag(s) in the metal cassette(s) and transfer AUCATZYL to the onsite controlled-access vapor phase of liquid nitrogen for storage below minus 150°C until ready for thaw and administration. Time out of the vapor phase liquid nitrogen environment should be kept to an absolute minimum to avoid premature product thaw (recommend not to exceed 90 seconds). An image of an infusion bag highlighting the following patient specific identifiers: apheresis ID, chain of identity ID, patient hospital ID, patient name, and patient date of birth. Planning prior to AUCATZYL preparation The patient batch specific Release for Infusion certificate and Dose Schedule Planner will be provided in the shipper and via Autolus' Scheduling Portal. Confirm the patient identifiers on the Release for Infusion certificate and infusion bags match, see Figure 2 . Ensure the patient's bone marrow assessment results are available. NOTE: The patient's bone marrow assessment results will be used to select the appropriate dosing regimen based on a Bone Marrow Blast of > 20% or ≤ 20%, see Figure 3 . The AUCATZYL Dose Schedule Planner is provided with the Release for Infusion certificate and assists the determination of the appropriate dose regimen to be administered on Day 1 (3 days (± 1 day) after the completion of lymphodepleting chemotherapy) and Day 10 (± 2 days). Record the following information on the Dose Schedule Planner: The blast percentage from the patient's bone marrow assessment. The AUCATZYL bag serial number(s); number of bag type required for each dose; and the specified volume to administer via syringe (for the 10 × 10 6 dose, Blue Bag) transcribed from the Release for Infusion certificate. The completion of the AUCATZYL Dose Schedule Planner will guide the treating physician on the number of bags required and preparation of AUCATZYL for the Day 1 and Day 10 (± 2 days) dose, see Figure 3 . Dose Preparation Do NOT irradiate. Do NOT use a leukodepleting filter. Confirm the patient's identity with the patient identifiers on the Release for Infusion certificate. Contact Autolus Inc at 1-855-288-5227 if there are any discrepancies between the labels and the patient identifiers. Confirm tocilizumab and emergency equipment are available prior to infusion and during the recovery period. Coordinate the timing of AUCATZYL thaw and infusion. Confirm the infusion time in advance and adjust the start time of AUCATZYL thaw such that it will be available for infusion when the patient is ready and will be infused within 60 minutes of thaw. Complete the AUCATZYL Dose Schedule Planner, as described above to identify the dose required for Day 1 and Day 10 (± 2 days) administration, see Figure 3 . Follow the completed AUCATZYL Dose Schedule Planner and refer to the patient batch specific Release for Infusion certificate to verify the bag(s) required for Day 1 or Day 10 (± 2 days) dosing, see Figure 3 . Transfer and Thawing Using the completed Dose Schedule Planner for guidance, transfer ONLY the cassette(s)/ infusion bag(s) required for the given dosing day from the onsite vapor phase liquid nitrogen storage to an appropriate transfer vessel (i.e., a vapor phase liquid nitrogen shipper, maintaining a temperature below minus 150°C) for transport to the bag thaw location. Transfer the required cassette(s) one by one, confirming the AUCATZYL bag serial numbers and patient identifiers on each infusion bag label, see Figure 2 . Time out of the vapor phase liquid nitrogen environment should be kept to an absolute minimum to avoid premature product thaw (recommend not to exceed 90 seconds). If more than one infusion bag is required on a given dosing day, thaw each infusion bag one at a time; Do NOT remove subsequent bags from the vapor phase liquid nitrogen storage (below minus 150°C) until the infusion of the previous bag is complete. AUCATZYL must be continuously monitored during thawing process. Leave the AUCATZYL infusion bag in its overwrap, thaw at 37°C using a water bath or dry thaw method until there are no visible frozen clumps left in the infusion bag. Each bag should be gently massaged until the cells have just thawed. Thawing of each infusion bag takes between 2 and 8 minutes. Remove from water bath or thaw device immediately after thawing is complete. Carefully remove the infusion bag from the overwrap taking care to avoid damage to the bag and ports. Gently mix the contents of the bag to disperse clumps of cellular material and administer immediately to the patient. Do not re-freeze or refrigerate thawed product. Figure 3: AUCATZYL Dosage and Schedule Bone Marrow Blast > 20% Day 1 Day 10 (± 2 days) 10 × 10 6 Dose administered via syringe Refer to Release for Infusion Certificate for the exact volume to be administered via syringe. Withdraw ONLY the volume. 100 × 10 6 Dose administered via bag infusion The 100 × 10 6 (Orange Bag) and 300 × 10 6 (Red Bag) doses will be suspended in one or more infusion bags. and 300 × 10 6 Dose administered via bag infusion Bone Marrow Blast ≤ 20% Day 1 Day 10 (± 2 days) 100 × 10 6 Dose administered via bag infusion 10 × 10 6 Dose administered via syringe and 300 × 10 6 Dose administered via bag infusion Image 2.4 Infusion Instructions AUCATZYL is for autologous and intravenous use only. The patient's identity must match the patient identifiers on the Release for Infusion certificate and infusion bag. Contact Autolus Inc at 1-855-288-5227 if there are any discrepancies between the labels and the patient identifiers. Dose administration for 10 × 10 6 CD19 CAR-positive viable T cell Dose (Blue Bag) Withdrawal of the 10 × 10 6 dose into the syringe should be carried as follows: Prepare and administer AUCATZYL using aseptic technique. Gently mix the contents of the bag to disperse clumps of cellular material. The volume to be administered for the 10 × 10 6 dose (Blue Bag) is specified on the Release for Infusion certificate. Use the smallest Luer-lock tip syringe necessary (1, 3, 5, or 10 mL) with a Luer-lock bag spike to draw up the volume as specified on the Release for Infusion certificate. Do NOT use a leukodepleting filter. Do NOT use the syringe to mix the cells, see Figure 4 . Figure 4 : Syringe Infusion Guidance for the 10 × 10 6 Dose (Blue Bag) Withdraw the volume from the 10 × 10 6 Dose (Blue Bag) specified on the Release for Infusion certificate using a syringe fitted with a bag spike. Do not use the syringe to mix the cells Confirm withdrawal of the exact volume specified on the Release for Infusion certificate for the 10 × 10 6 Dose (Blue Bag). Prime the tubing with normal saline prior to infusion. Once AUCATZYL has been drawn into the syringe, verify the volume and administer as an intravenous infusion as soon as possible as a slow push (approximately 0.5 mL/minute) through a central venous line (or large peripheral venous access line appropriate for blood products). Complete infusion at room temperature within 60 minutes post thaw and flush the tubing line with 60 mL of normal saline. Dispose of any unused portion of AUCATZYL (according to local biosafety guidelines). An image depicting how to withdraw the dose from the bag. An image depicting that the syringe should not be used to mix. An image depicting that only the volume specified in the release for infusion certificate should be withdrawn. Dose administration for 100 × 10 6 (Orange Bag) and/or 300 × 10 6 (Red Bag) CD19 CAR-positive viable T cells Refer to the Release for Infusion certificate and Dose Schedule Planner for the following details: The volume and total CD19 CAR-positive viable T cell number contained in each infusion bag. The dose to be administered on the given dosing day and the number of bags required to deliver the specified CD19 CAR-positive viable T cell dose. If more than one bag is needed, thaw subsequent bags after the previous bag is fully administered. Prime the tubing with normal saline prior to infusion. Administer AUCATZYL via a gravity or peristaltic pump assisted IV infusion through a central venous line (or large peripheral venous access line appropriate for blood products). Do NOT use a leukodepleting filter. Aseptic techniques must be applied when performing a venepuncture, spiking the ports, and through the cell administration process. Gently mix the contents of the bag during AUCATZYL infusion to disperse cell clumps. Infuse the entire content of the AUCATZYL infusion bag at room temperature within 60 minutes post thaw (infusion rate within 0.1 to 27 mL/minute). After the entire content of the infusion bag is infused, rinse the bag with 30 mL of normal saline, then flush the tubing line with 60 mL of normal saline. Repeat steps 1 - 3 for any additional infusion bags required on the given dosing day. Do NOT initiate thaw of the next bag until infusion of the previous bag is complete. AUCATZYL contains human blood cells that are genetically modified with replication-incompetent lentiviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal of AUCATZYL to avoid potential transmission of infectious diseases. Monitoring Monitor patients for signs and symptoms of CRS, neurologic toxicities/ICANS and other acute toxicities daily for at least 7 days following each infusion. Continue to monitor patients for at least 2 weeks following each infusion. Instruct patients to remain within proximity of a healthcare facility for at least 2 weeks following each infusion. Avoid driving for at least 2 weeks after each infusion.

4 CONTRAINDICATIONS None. None ( 4 ).

6 ADVERSE REACTIONS The most common (non-laboratory) adverse reactions (incidence ≥ 20%) are: CRS, infections - pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Autolus Inc at toll-free phone 1-855-288-5227 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 17 ). 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 10 6 CD19 CAR-positive viable T cells (range: 10 to 480 × 10 6 CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 10 6 ± 25%) [see Clinical Studies (14) ] . The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL. Table 3 summarizes the adverse reactions (excluding laboratory abnormalities) that occurred in at least 10% of patients. Table 4 presents the most common Grade 3 or 4 laboratory abnormalities, occurring in at least 10% of patients. Table 3: Adverse Reactions Occurring in ≥ 10% of Patients in FELIX Study (N=100) Adverse Reaction Any Grade (%) Grade 3 or Higher (%) Blood and lymphatic system disorders Febrile neutropenia 26 26 Coagulopathy Is a composite that includes multiple related terms. 10 6 Cardiac disorders Tachycardia 12 0 Gastrointestinal disorders Nausea 29 2 Diarrhea 26 0 Vomiting 18 0 Abdominal pain 16 1 Constipation 11 0 General disorders and administration site conditions Fever 29 1 Pain 23 0 Fatigue 22 3 Edema 12 0 Chills 11 0 Immune system disorders Cytokine release syndrome 75 3 Hypogammaglobulinemia 10 2 Infections and infestations Infections - pathogen unspecified 44 31 Viral infections excluding COVID-19 16 1 COVID-19 18 6 Bacterial infections 26 11 Fungal infections 15 5 Investigations Weight decreased 11 2 Metabolism and nutrition disorders Decreased appetite 13 3 Musculoskeletal and connective tissue disorders Musculoskeletal pain 36 4 Nervous system disorders Immune effector cell-associated neurotoxicity syndrome 24 7 Headache 22 0 Encephalopathy Encephalopathy includes aphasia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes, posterior reversible encephalopathy syndrome, somnolence. 21 4 Dizziness 14 0 Respiratory, thoracic and mediastinal disorders Cough 14 0 Skin and subcutaneous tissue disorders Rash 17 1 Vascular disorders Hypotension 23 4 Hemorrhage 20 4 Other clinically important adverse reactions that occurred in less than 10% of patients treated with AUCATZYL include the following: Cardiac disorders: arrhythmia (5%), palpitations (2%), cardiac failure (1%). Endocrine disorders: adrenal insufficiency (2%). Eye disorders: visual impairment (2%). Gastrointestinal disorders: stomatitis (5%), ascites (4%). Immune system disorders: graft versus host disease (4%), HLH/MAS (2%). Injury, poisoning and procedural complications: infusion related reaction (2%). Nervous system and psychiatric disorders: tremor (8%), motor dysfunction (6%), delirium (5%), seizure (2%). Renal disorders: renal impairment (7%). Respiratory disorders: respiratory failure (8%), pleural effusion (4%). Skin and subcutaneous tissue disorders: skin ulcer (2%). Vascular disorders: thrombosis (5%). Table 4: Grade 3 or 4 Laboratory abnormalities graded using NCI Common Terminology Criteria for Adverse Events version 5.0. Laboratory Abnormalities that Worsened from Baseline Baseline laboratory values were assessed prior to lymphodepleting chemotherapy. in ≥ 10% of Patients in FELIX Study (N=100) Laboratory Abnormality Grades 3 or 4 (%) Lymphocytopenia 90 Leukopenia 87 Neutropenia 72 Thrombocytopenia 48 Anemia 43 Hyperferritinemia 13 Aspartate aminotransferase increased 10 6.2 Postmarketing Experience Because adverse events to marketed products are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse event has been identified during postmarketing use of BCMA- or CD19-directed genetically modified autologous T cell immunotherapies: Neoplasms: T cell malignancies.

What is AUCATZYL used for?
1 INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ( 1 ).

Who makes AUCATZYL?
Autolus Inc. is the labeler of record for AUCATZYL.

Is AUCATZYL prescription or over-the-counter?
The FDA label for this product is recorded as cellular therapy. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has AUCATZYL been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.