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boxed warning
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ]. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.2) ]. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies [see Warnings and Precautions (5.8) ]. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. ( 2.2 , 2.3 , 5.1 ). Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities ( 2.2 , 2.3 , 5.2 ). T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies ( 5...
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following AUCATZYL infusion. Monitor complete blood counts ( 5.3 ). Infections: Monitor patients for signs and symptoms of infection; treat appropriately ( 5.4 ). Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy ( 5.5 ). Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome: Administer treatment per institutional standards ( 5.6 ). Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion ( 5.7 ). Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. In the event that a secondary malignancy occurs after treatment with AUCATZYL, contact Autolus Inc at 1-855-288-5227 ( 5.8 ). 5.1 Cytokine Release Syndrome Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). Sixty-eight percent of patients (51/75) experienced CRS after the first infusion, but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 10 days). Among patients with CRS, the most common manifestations of CRS included fever (100%), hypotension (35%) and hypoxia (19%) [see Adverse Reactions (6) ] . The primary treatment for CRS was tocilizumab (73%; 55/75), with patients also receiving corticosteroids (21%; 16/75). Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 7 days following each infusion. Continue to monitor patients for CRS for at least 2 weeks following each infusion with AUCATZYL [see Dosage and Administration (2.1) ] . Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per curr...
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adverse reactions
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 Ta...
adverse reactions table
Table 3: Adverse Reactions Occurring in ≥ 10% of Patients in FELIX Study (N=100)Adverse ReactionAny Grade (%)Grade 3 or Higher (%)Blood and lymphatic system disordersFebrile neutropenia2626Coagulopathy Is a composite that includes multiple related terms.106Cardiac disordersTachycardia 120Gastrointestinal disordersNausea292Diarrhea260Vomiting180Abdominal pain 161Constipation110General disorders and administration site conditionsFever291Pain 230Fatigue 223Edema 120Chills110Immune system disordersCytokine release syndrome753Hypogammaglobulinemia102Infections and infestationsInfections - pathogen unspecified 4431Viral infections excluding COVID-19 161 COVID-19 186Bacterial infections 2611Fungal infections 155InvestigationsWeight decreased112Metabolism and nutrition disordersDecreased appetite133Musculoskeletal and connective tissue disordersMusculoskeletal pain 364Nervous system disordersImmune effector cell-associated neurotoxicity syndrome247Headache220Encephalopathy 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.214Dizziness 140Respiratory, thoracic and mediastinal disordersCough 140Skin and subcutaneous tissue disordersRash 171Vascular disordersHypotension 234Hemorrhage 204
1 KIT in 1 PACKAGE (83047-410-04) * 1 SUSPENSION in 1 BAG (83047-100-30) * 1 SUSPENSION in 1 BAG (83047-100-10) * 1 SUSPENSION in 1 BAG (83047-300-30) * 1 SUSPENSION in 1 BAG (83047-010-10)