TECARTUS

TECARTUS is an FDA-registered drug product whose active ingredient is BREXUCABTAGENE AUTOLEUCEL. It is labelled by Kite Pharma, Inc. taken by intravenous and marketed as a cellular therapy product. Identifiers on file: NDC 71287-219, application BLA125703, label effective 20260616. 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 BREXUCABTAGENE AUTOLEUCEL are most often described in connection with: adult patients, relapsed refractory, mantle cell, acute lymphoblastic, lymphoma mcl, b-cell precursor, tecartus indicated, directed genetically. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 1.2 Acute Lymphoblastic Leukemia TECARTUS is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of TECARTUS. ( 2.2 ) Verify the patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and diphenhydramine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) MCL: dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. ( 2.1 ) ALL: dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. Recommended Dosage for MCL The target dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. Recommended Dosage for ALL The target dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. 2.2 Administration TECARTUS is for autologous use only. The patient's identity must match the patient identifiers on the TECARTUS cassette and infusion bag. Do not infuse TECARTUS if the information on the patient-specific label does not match the intended patient. Preparing Patient for TECARTUS Infusion Confirm availability of TECARTUS prior to starting the lymphodepleting chemotherapy regimen. Pre-treatment MCL: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on each of the fifth, fourth, and third day before infusion of TECARTUS. ALL: Administer a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m 2 intravenously over 30 minutes on the fourth, third, and second day and administer cyclophosphamide 900 mg/m 2 over 60 minutes on the second day before infusion of TECARTUS. Premedication Premedicate with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to TECARTUS infusion. Avoid prophylactic use of systemic corticosteroids as it may interfere with the activity of TECARTUS. Preparation of TECARTUS for infusion Coordinate the timing of TECARTUS thaw and infusion. Confirm the infusion time in advance, and adjust the start time of TECARTUS thaw such that TECARTUS will be available for infusion when the patient is ready. Confirm patient identity: Prior to TECARTUS preparation, match the patient's identity with the patient identifiers on the TECARTUS cassette. Do not remove the TECARTUS infusion bag from the cassette if the patient information on the cassette label does not match the intended patient. Once patient identity is confirmed, remove the TECARTUS infusion bag from the cassette and check that the patient information on the cassette label matches the patient information on the bag label. Inspect the infusion bag for any breaches of container integrity such as breaks or cracks before thawing. If the bag is compromised, follow the local guidelines (or call Kite at 1-844-454-KITE). Place the infusion bag inside a second sterile bag per local guidelines. Thaw the infusion bag at approximately 37°C using either a water bath or dry-thaw method until there is no visible ice in the infusion bag. Gently mix the contents of the bag to disperse clumps of cellular material. If visible cell clumps remain, continue to gently mix the contents of the bag. Small clumps of cellular material should disperse with gentle manual mixing. Do not wash, spin down, and/or re-suspend TECARTUS in new media prior to infusion. Once thawed, TECARTUS should be administered within 30 minutes but may be stored at room temperature (20°C to 25°C) for up to 3 hours. Administration For autologous use only. Confirm that tocilizumab and emergency equipment are available prior to infusion and during the recovery period. Do NOT use a leukodepleting filter. Central venous access is recommended for the administration of TECARTUS. Confirm that the patient's identity matches the patient identifiers on the TECARTUS infusion bag. Prime the tubing with normal saline prior to infusion. Infuse the entire contents of the TECARTUS bag within 30 minutes by either gravity or a peristaltic pump. TECARTUS is stable at room temperature for up to 3 hours after thaw. Gently agitate the TECARTUS bag during infusion to prevent cell clumping. After the entire contents of the TECARTUS bag are infused, rinse the tubing with normal saline at the same infusion rate to ensure all product is delivered. TECARTUS contains human blood cells that are genetically modified with replication-incompetent retroviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal of TECARTUS to avoid potential transmission of infectious diseases. Monitoring Monitor patients daily for at least 7 days following infusion for signs and symptoms of Cytokine Release Syndrome (CRS) and neurologic events. Instruct patients to remain within proximity of a healthcare facility for at least 2 weeks following infusion. Advise patients to avoid driving for at least 2 weeks following infusion. 2.3 Management of Severe Adverse Reactions Cytokine Release Syndrome (CRS) Identify CRS based on clinical presentation [see Warnings and Precautions (5.1) ] . Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage according to the recommendations in Table 1. Patients who experience Grade 2 or higher CRS (e.g., hypotension, not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry. For patients experiencing severe CRS, consider performing an echocardiogram to assess cardiac function. For severe or life-threatening CRS, consider intensive care supportive therapy. Physicians may also consider management per current practice guidelines. Table 1. CRS Grading and Management Guidance CRS Grade Lee et al. 2014. / Supportive Care Tocilizumab Corticosteroids Abbreviations: ICU, intensive care unit; IV, intravenous/intravenously Grade 1 Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise). Supportive care with antipyretics, IV hydration, and symptomatic management of organ toxicities and constitutional symptoms If not improving after 24 hours, administer tocilizumab Refer to tocilizumab Prescribing Information for details. 8 mg/kg IV over 1 hour (not to exceed 800 mg). Not applicable. Grade 2 Symptoms require and respond to moderate intervention. Oxygen requirement less than 40% FiO 2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity. Refer to Table 2 for management of neurologic toxicity. Continue supportive care as per Grade 1 and include IV fluid bolus and/or supplemental oxygen as needed Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg). Repeat tocilizumab every 8 hours as needed if not responsive to IV fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses if no clinical improvement in the signs and symptoms of CRS. If improving, discontinue tocilizumab. In patients with hypotension that persists after 2 fluid boluses and after 1 to 2 doses of tocilizumab, may consider dexamethasone 10 mg IV (or equivalent) every 12 hours for 1 to 2 doses and then reassess. Manage per Grade 3 if no improvement within 24 hours after starting tocilizumab. If improving, taper corticosteroids. Grade 3 Symptoms require and respond to aggressive intervention. Oxygen requirement greater than or equal to 40% FiO 2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis. Transfer to ICU Continue supportive care per Grade 2. If echocardiogram was not already performed, obtain ECHO to assess cardiac function and conduct hemodynamic monitoring. Per Grade 2 If improving, discontinue tocilizumab. Administer dexamethasone 10 mg IV every 6-8 hours or methylprednisolone 1 mg/kg IV twice daily until Grade 1, then taper corticosteroids. If improving, manage as Grade 2. If not improving, manage as Grade 4. Grade 4 Life-threatening symptoms. Requirements for ventilator support or continuous veno-venous hemodialysis (CVVHD), or Grade 4 organ toxicity (excluding transaminitis). Transfer to ICU Continue supportive care as per Grade 2. Per Grade 2 If improving, discontinue tocilizumab. If not improving, consider alternate immunosuppressants Refer to current practice guidelines for alternative immunosuppressant agents. Administer methylprednisolone 1000 mg IV per day for 3 days. If improving, taper corticosteroids, and manage as Grade 3. If not improving during first 24 hours, consider adding alternate immunosuppressants. Neurologic Toxicity Monitor patients daily for signs and symptoms of neurologic toxicities/immune effector cell-associated neurotoxicity syndrome (ICANS) (Table 2). Rule out other causes of neurologic symptoms. Patients who experience Grade 2 or higher neurologic toxicities/ICANS should be monitored with continuous cardiac telemetry and pulse oximetry and provide neuroimaging of the brain (brain MRI or CT scan); for persisting Grade 2 or higher neurologic toxicities/ICANS consider repeat neuroimaging every 2 – 3 days. Provide intensive care supportive therapy for severe or life-threatening neurologic toxicities/ICANS. Consider non-sedating anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis for any Grade 2 or higher neurologic toxicities. Physicians may also consider management per current practice guidelines. Table 2. Neurologic Toxicity/ICANS Grading and Management Guidance Neurologic Event Severity based on Common Terminology Criteria for Adverse Events. Concurrent CRS No Concurrent CRS Abbreviation: ADLs, activities of daily living; ICE, immune effector cell–associated encephalopathy; ICU, intensive care unit; IV, intravenous/intravenously Grade 1 ICANS Severity based on American Society of Transplantation and Cellular Therapy (ASTCT) consensus grading Grade 1: ICE score 7-9 Examples include: Somnolence – mild drowsiness or sleepiness Confusion – mild disorientation Encephalopathy – mild limiting of ADLs Dysphasia – not impairing ability to communicate Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg). Repeat tocilizumab every 8 hours as needed. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. Consider adding corticosteroids (dexamethasone 10mg IV) to tocilizumab past the first dose. Supportive care. If persisting, consider corticosteroids (dexamethasone 10 mg IV). Grade 2 ICANS Grade 2 : ICE score 3-6 Examples include: Somnolence – awakening to voice moderate limiting instrumental ADLs Confusion – moderate disorientation Encephalopathy – limiting instrumental ADLs Dysphasia moderate impairing ability to communicate spontaneously Seizure(s) Administer tocilizumab per Table 1 for management of Grade 2 CRS. Consider adding corticosteroids (dexamethasone 10 mg IV or methylprednisolone 1 mg/kg IV every 12 hours) to tocilizumab past the first dose, if symptoms are refractory to tocilizumab. Consider transfer in ICU, if ICANS associated with ≥ Grade 2 CRS. If not improving within 24 hours after starting tocilizumab, administer dexamethasone 10 mg IV every 6 hours or methylprednisolone 1 mg/kg IV every 12 hours until the event is Grade 1 or less, then rapidly taper corticosteroids. If improving, discontinue tocilizumab. If still not improving, manage as Grade 3. Administer dexamethasone 10 mg IV every 6 hours until the event is Grade 1 or less. If improving, taper corticosteroids. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Grade 3 ICANS Grade 3 : ICE score 0-2 Examples include: Somnolence – obtundation or stupor; awakening only to tactile stimulus Confusion – severe disorientation Encephalopathy – limiting self-care ADLs Dysphasia – severe receptive or expressive characteristics, impairing ability to read, write, or communicate intelligibly Seizure(s) focal / non-convulsive seizures on EEG, Focal or local edema on neuroimaging Transfer to ICU Administer tocilizumab per Table 1 for management of Grade 2 CRS. In addition, administer dexamethasone 10 mg IV every 6 hours or methylprednisolone 1 mg/kg IV every 8 to 12 hours starting with the first dose of tocilizumab and repeat dose every 6 hours. Continue dexamethasone or methylprednisolone use until the event is Grade 1 or less, then taper corticosteroids. If improving, discontinue tocilizumab and manage as Grade 2. If still not improving, manage as Grade 4. Transfer to ICU Administer dexamethasone 10 mg IV every 6 hours or methylprednisolone 1 mg/kg IV every 8 to 12 hours. Continue dexamethasone/methylprednisolone use until the event is Grade 1 or less, then taper corticosteroids. If not improving, manage as Grade 4. Consider non-sedating anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Grade 4 ICANS Grade 4 : ICE score 0 Life-threatening consequences Urgent intervention required Requirement for mechanical ventilation Life-threatening / prolonged seizure Diffuse cerebral edema on neuro-imaging Transfer to ICU Administer tocilizumab per Table 1 for management of Grade 2 CRS. Administer methylprednisolone 1000 mg IV 1-2 times per day with first dose of tocilizumab and continue methylprednisolone 1000 mg IV per day for 2 more days. If improving, then manage as Grade 3. If not improving, consider alternate immunosuppressants. Refer to current practice guidelines for alternative immunosuppressant agents. Transfer to ICU Administer methylprednisolone 1000 mg IV 1-2 times per day for 3 days. If improving, then manage as Grade 3. If not improving, consider alternate immunosuppressants. Consider non-sedating anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction. ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Kite at 1-844-454-KITE (5483) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. Study 1 (Relapsed/Refractory Mantle Cell Lymphoma) Cohort 1 and 2 The safety of TECARTUS in patients with relapsed/refractory Mantle cell lymphoma (MCL) was evaluated in a single-arm study (Study 1; Cohorts 1 and 2) in which a total of 82 patients received a single dose of TECARTUS (2 × 10 6 or 0.5 × 10 6 anti-CD19 CAR T cells/kg) [see Clinical Studies (14.1) ] . The most common serious adverse reactions (> 2%) were encephalopathy, fever, infection with pathogen unspecified, CRS, hypoxia, aphasia, renal insufficiency, pleural effusion, respiratory failure, bacterial infections, dyspnea, fatigue, arrhythmia, tachycardia, and viral infections. Table 3 summarizes the adverse reactions that occurred in at least 10% of patients in Study 1 Cohorts 1 and 2 and Table 4 lists the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients in Study 1 Cohorts 1 and 2. Table 3. Adverse Reactions Observed in at Least 10% of Patients in Study 1 (Cohorts 1 and 2) (N=82) Adverse Reaction Any Grade (%) Grade ≥3 (%) Blood and Lymphatic System Disorders Coagulopathy Includes multiple related terms. 10 2 Cardiac Disorders Tachycardias 45 0 Bradycardias 10 0 Non-ventricular Arrhythmias 10 4 Gastrointestinal Disorders Nausea 35 1 Constipation 29 0 Diarrhea 28 5 Abdominal pain 17 0 Oral pain 16 0 Vomiting 13 0 Dysphagia 10 2 General Disorders and Administration Site Conditions Fever 94 15 Fatigue 48 1 Chills 41 0 Edema 35 2 Pain 17 2 Immune System Disorders Cytokine release syndrome 91 18 Hypogammaglobulinemia 16 1 Infections and Infestations Infection with pathogen unspecified 43 24 Viral infections 18 4 Bacterial infections 13 6 Metabolism and Nutrition Disorders Decreased appetite 26 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain 37 2 Motor dysfunction Motor dysfunction includes asthenia, intensive care acquired weakness, mobility decreased, muscle twitching, muscular weakness, myopathy. 17 4 Nervous System Disorders Encephalopathy Encephalopathy includes encephalopathy, altered state of consciousness, amnesia, balance disorder, cognitive disorder, confusional state, disturbance in attention, dysgraphia, dyskinesia, memory impairment, mental status changes, neurotoxicity, somnolence. 51 24 Tremor 38 2 Headache 35 1 Aphasia 20 7 Dizziness Dizziness includes dizziness, presyncope, syncope. 18 6 Neuropathy Neuropathy includes hyperaesthesia, neuropathy peripheral, paraesthesia, paraesthesia oral. 13 2 Psychiatric Disorders Insomnia 21 0 Delirium Delirium includes delirium, agitation, disorientation, hallucination, hypomania, irritability, nervousness, personality change. 18 5 Anxiety 16 0 Renal and Urinary Disorders Renal insufficiency 18 9 Urine output decreased 11 1 Respiratory, Thoracic and Mediastinal Disorders Hypoxia 40 20 Cough 38 0 Dyspnea 24 6 Pleural effusion 21 5 Skin and Subcutaneous Tissue Disorders Rash 22 4 Vascular Disorders Hypotension 57 27 Hypertension 18 11 Thrombosis Thrombosis includes thrombosis, deep vein thrombosis, embolism, pulmonary embolism. 17 4 Other clinically important adverse reactions that occurred in less than 10% of patients include the following: Gastrointestinal disorders: dry mouth (7%) Infections and infestations disorders: fungal infections (9%) Metabolism and nutrition disorders: dehydration (6%) Nervous system disorders: ataxia (7%), seizure (5%), increased intracranial pressure (2%) Respiratory, thoracic and mediastinal disorders: respiratory failure (6%), pulmonary edema (4%) Skin and subcutaneous tissue disorders: rash (9%) Vascular disorders: hemorrhage (7%) Table 4. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in Study 1 (Cohorts 1 and 2) Following TECARTUS Infusion (N = 82) Grades 3 or 4 (%) Leukopenia 95 Neutropenia 95 Lymphopenia 86 Thrombocytopenia 63 Anemia 55 Hypophosphatemia 30 Hypocalcemia 21 Blood uric acid increased 17 Hyponatremia 16 Aspartate Aminotransferase increased 15 Alanine Aminotransferase increased 15 Hypokalemia 10 Cohort 3 The safety of TECARTUS in patients with relapsed/refractory MCL who had been treated with up to 5 prior treatment regimens but had not received prior therapy with a Bruton tyrosine kinase inhibitor (BTKi) was evaluated in Study 1 Cohort 3. A total of 86 patients were treated with a single dose of TECARTUS (2 × 10 6 or 0.5 × 10 6 anti-CD19 CAR T cells/kg) [see Clinical Studies (14.1) ]. Serious adverse reactions occurred in 65% of patients. The most common serious adverse reactions (>2%) were non-ventricular arrhythmias, tachycardias, pyrexia, cytokine release syndrome, unspecified pathogen infections, viral infections, bacterial infections, fungal infections, musculoskeletal pain, motor dysfunction, encephalopathy, aphasia, tremor, seizure, delirium, hypoxia, hypotension, hemorrhage, and thrombosis. Table 5 summarizes the adverse reactions that occurred in at least 10% of patients in Study 1 Cohort 3 and Table 6 lists the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients in Study 1 Cohort 3. Table 5. Adverse Reactions Observed in at Least 10% of Patients in Study 1 (Cohort 3) (N=86) Adverse Reaction Any Grade (%) Grade ≥3 Cardiac Disorders Tachycardias Includes multiple related terms 20 1 Non-ventricular Arrhythmias 13 3 Gastrointestinal Disorders Nausea 33 1 Constipation 28 0 Diarrhea 24 0 Abdominal pain 19 1 Vomiting 15 0 Oral pain 14 1 General Disorders and Administration Site Conditions Fever 94 17 Fatigue 43 2 Edema 21 0 Chills 19 0 Immune System Disorders Cytokine release syndrome 95 6 Infections and Infestations Infection with pathogen unspecified 49 23 Viral infections 49 16 Bacterial infections 14 7 Fungal infections 14 2 Metabolism and Nutrition Disorders Decreased appetite 24 9 Weight decreased 12 1 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain 24 0 Motor dysfunction Motor dysfunction includes Asthenia, Facial paresis, Fine motor skill dysfunction, Monoparesis, Motor dysfunction, Muscular weakness, Muscle spasms, Myoclonus, Myopathy, Paraparesis, Peroneal nerve palsy 20 3 Nervous System Disorders Encephalopathy Encephalopathy includes Agnosia, Agraphia, Altered state of consciousness, Amnesia, Anal incontinence, Aphasia, Balance disorder, Bradyphrenia, Cerebellar syndrome, Cognitive disorder, Confusional state, Depressed level of consciousness, Disturbance in attention, Dysarthria, Dysgeusia, Dysgraphia, Dysmetria, Dysphagia, Encephalopathy, Lethargy, Loss of consciousness, Memory impairment, Mental status changes, Neurological decompensation, Somnolence, Speech disorder, Toxic encephalopathy 66 24 Tremor Tremor includes Action tremor, Postural tremor, Tremor 30 2 Headache 29 0 Dizziness Dizziness includes Dizziness, Syncope 16 5 Peripheral neuropathy Peripheral Neuropathy includes Hypoesthesia, Neuropathy peripheral, Paresthesia, Paresthesia oral, Peripheral motor neuropathy, Peripheral sensory neuropathy, Polyneuropathy 12 1 Psychiatric Disorders Delirium Delirium includes Agitation, Delirium, Disorientation, Hallucination, Hallucinations, mixed, Nervousness 17 1 Insomnia 12 0 Renal and Urinary Disorders Renal insufficiency 19 2 Respiratory, Thoracic and Mediastinal Disorders Hypoxia 24 10 Cough 14 0 Dyspnea 14 5 Skin and Subcutaneous Tissue Disorders Rash 16 0 Vascular Disorders Hypotension 52 8 Hemorrhage 16 5 Thrombosis Thrombosis includes Deep vein thrombosis, Embolism, Jugular vein thrombosis, Peripheral vein thrombosis, Pulmonary embolism, Venous thrombosis 13 3 Hypertension 10 2 Other clinically important adverse reactions that occurred in less than 10% of patients include the following: Blood and lymphatic system disorders: coagulopathy (5%), febrile neutropenia (1%) Cardiac disorders: Bradycardia (1%) Eye disorders: Visual impairment (6%) Gastrointestinal disorders: dry mouth (7%), dysphagia (1%) General disorders and administration site conditions: Pain (9%) Immune system disorders: hypersensitivity (1%), hypogammaglobulinemia (9%) Metabolism and nutrition disorders: dehydration (6%) Nervous system disorders: ataxia (9%), increased intracranial pressure (1%), seizure (5%) Psychiatric disorders: anxiety (8%) Renal and urinary disorders: urine output decreased (1%) Respiratory, thoracic and mediastinal disorders: pleural effusion (1%), pulmonary edema (3%), respiratory failure (6%) Table 6. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in Study 1 (Cohort 3) Following TECARTUS Infusion (N=86) Grades 3 or 4 (%) Leukopenia 97 Lymphopenia 96 Neutropenia 91 Thrombocytopenia 44 Hypophosphatemia 40 Anemia 31 Hyperglycemia 29 Blood uric acid increased 28 Alanine Aminotransferase increased 27 Hyponatremia 22 Calcium increased 12 Creatinine increased 12 Direct bilirubin increased 12 Magnesium increased 12 Aspartate Aminotransferase increased 10 Hypocalcemia 10 Study 2 (Relapsed/Refractory B-cell precursor Acute Lymphoblastic Leukemia) The safety of TECARTUS in patients with relapsed/refractory ALL was evaluated in an open-label, multicenter study in which a total of 78 patients received a single dose of CAR-positive T cells (1 x 10 6 anti-CD19 CAR T cells/kg) [see Clinical Studies (14.2) ] . The most common serious adverse reactions (≥ 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis. Fatal adverse reactions occurred in 5% (4/78) of patients including cerebral edema, sepsis, and fungal pneumonia. Of the 4 patients who had fatal adverse reactions: 1 patient with fatal pneumonia had pre-existing pneumonia prior to study enrollment, and 1 patient with fatal sepsis had prolonged cytopenia and immunosuppression from prior therapies and underlying disease. Table 7 summarizes the adverse reactions that occurred in at least 10% of patients in Study 2 and Table 8 describes the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients in Study 2. Table 7. Adverse Reactions Observed in at Least 10% of Patients in Study 2 (N=78) Adverse Reaction Any Grade (%) Grade ≥3 (%) Blood and Lymphatic System Disorders Febrile Neutropenia Febrile neutropenia includes febrile neutropenia (11 (14%)) and fever occurring concurrently with neutropenia events (16 (21%)) 35 35 Coagulopathy Represents a composite of multiple, related preferred terms 17 5 Cardiac Disorders Tachycardias 63 6 Arrhythmia Arrhythmia includes cardiac arrest, . 15 1 Gastrointestinal Disorders Nausea 41 1 Diarrhea 32 6 Abdominal pain 19 0 Constipation 24 0 Vomiting 21 3 General Disorders and Administration Site Conditions Fever 96 38 Chills 40 0 Edema 29 5 Fatigue 37 1 Pain 13 1 Immune System Disorders Cytokine release syndrome 92 26 Infections and Infestations Infection with pathogen unspecified 28 22 Bacterial infections 15 8 Fungal infections 13 5 Metabolism and Nutrition Disorders Decreased appetite 22 1 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain 32 5 Muscular weakness 14 1 Nervous System Disorders Encephalopathy Encephalopathy includes altered state of consciousness, aphasia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, encephalopathy, immune effector cell-associated neurotoxicity syndrome, memory impairment, mental status changes, slow response to stimuli, slow speech, somnolence, speech disorder. 63 27 Headache 38 1 Tremor 29 1 Dizziness Dizziness includes dizziness, syncope. 13 1 Psychiatric Disorders Delirium Delirium includes agitation, delirium, delusion, disorientation, hallucination. 18 5 Anxiety 12 0 Insomnia 13 0 Respiratory, Thoracic and Mediastinal Disorders Hypoxia 31 23 Cough 12 0 Dyspnea 12 1 Skin and Subcutaneous Tissue Disorders Rash 31 0 Vascular Disorders Hypotension 69 33 Hemorrhage Hemorrhage includes conjunctival hemorrhage, contusion, epistaxis, gastric hemorrhage, hematoma, hematoma muscle, hemorrhage intracranial, hemorrhoidal hemorrhage, menorrhagia, petechiae, pulmonary alveolar hemorrhage, retinal hemorrhage, vaginal hemorrhage, vitreous hemorrhage. 13 4 Hypertension 13 6 Other clinically important adverse reactions that occurred in less than 10% of patients include the following: Cardiac disorder: cardiac failure (4%), palpitations (3%) Eye disorders: visual impairment (9%) Gastrointestinal disorders: dry mouth (6%), dysphagia (4%), oral pain (1%) Immune system disorders: hypogammaglobulinemia (9%), hemophagocytic lymphohistiocytosis (4%), drug hypersensitivity (1%) Infections and infestations: viral infections (6%) Metabolism and nutrition disorders: dehydration (5%), tumor lysis syndrome (1%) Musculoskeletal and connective tissue disorders: muscle spasms (4%), musculoskeletal stiffness (3%) Nervous system disorders: seizure (8%), ataxia (5%), peripheral neuropathy (4%), myoclonus (3%), paraparesis (3%), brain edema (1%), brain herniation (1%), cauda equina syndrome (1%), monoplegia (1%) Renal and urinary disorders: renal impairment (6%) Respiratory, thoracic and mediastinal disorders: respiratory failure (9%), pulmonary edema (6%), pleural effusion (4%), pneumonitis (4%) Skin and subcutaneous tissue disorders: skin lesion (4%), decubitus ulcer (3%), dry skin (3%), skin ulcer (3%), alopecia (1%), hyperhidrosis (1%), skin hyperpigmentation (1%) Vascular disorders: thrombosis (4%) Table 8. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in Study 2 Following TECARTUS Infusion (N = 78) Grades 3 or 4 (%) Leukopenia 99 Neutropenia 97 Lymphopenia 96 Thrombocytopenia 87 Anemia 77 Hypophosphatemia 47 Alanine aminotransferase increased 31 Aspartate aminotransferase increased 23 Hyperglycemia 22 Hypocalcemia 22 Blood uric acid increased 19 Direct bilirubin increased 19 Hyponatremia 19 Hypokalemia 13 Hyperbilirubinemia 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 TECARTUS: Immune System Disorders : Infusion related reaction 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 TECARTUS used for?
1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with …

Who makes TECARTUS?
Kite Pharma, Inc. is the labeler of record for TECARTUS.

What form does TECARTUS come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TECARTUS 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 TECARTUS 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.