Yescarta
axicabtagene ciloleucel · Suspension · Intravenous
Uses
1 INDICATIONS AND USAGE YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1.2 ) 1.1 Large B-cell Lymphoma YESCARTA is indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. 1.2 Follicular Lymphoma YESCARTA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Dosage and administration
For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. ( 2.2 ) Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of YESCARTA. ( 2.2 ) Verify the patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and an H1-antihistamine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) The target YESCARTA 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 ) 2.1 Dose For autologous use only. For intravenous use only. Each single infusion bag of YESCARTA contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. 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. 2.2 Administration YESCARTA is for autologous use only. The patient's identity must match the patient identifiers on the YESCARTA cassette and infusion bag. Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient. Preparing Patient for YESCARTA Infusion Confirm availability of YESCARTA prior to starting the lymphodepleting regimen. Pre-treatment Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of YESCARTA. Premedication Administer acetaminophen 650 mg PO and diphenhydramine 12.5 mg intravenously or PO approximately 1 hour before YESCARTA infusion. Consider the use of prophylactic corticosteroid in patients after weighing the potential benefits and risks [see Warnings and Precautions (5.1 and 5.2) ] . Preparation of YESCARTA for Infusion Coordinate the timing of YESCARTA thaw and infusion. Confirm the infusion time in advance, and adjust the start time of YESCARTA thaw such that it will be available for infusion when the patient is ready. Confirm patient identity: Prior to YESCARTA preparation, match the patient's identity with the patient identifiers on the YESCARTA cassette. Do not remove the YESCARTA product bag from the cassette if the information on the patient-specific label does not match the intended patient. Once patient identification is confirmed, remove the YESCARTA product bag from the cassette and check that the patient information on the cassette label matches the bag label. Inspect the product 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 YESCARTA 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 YESCARTA in new medium prior to infusion. Once thawed, YESCARTA 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 infusion of YESCARTA. Confirm the patient's identity matches the patient identifiers on the YESCARTA product bag. Prime the tubing with normal saline prior to infusion. Infuse the entire contents of the YESCARTA bag within 30 minutes by either gravity or a peristaltic pump. YESCARTA is stable at room temperature for up to 3 hours after thaw. Gently agitate the product bag during YESCARTA infusion to prevent cell clumping. After the entire content of the product bag is infused, rinse the tubing with normal saline at the same infusion rate to ensure all product is delivered. YESCARTA contains human blood cells that are genetically modified with replication incompetent retroviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal to avoid potential transmission of infectious diseases. Monitoring Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS and neurologic toxicities. 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. Tocilizumab Corticosteroids Grade 1 Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise). If symptoms (e.g., fever) not improving after 24 hours, consider managing as Grade 2. If not improving after 3 days, administer one dose of dexamethasone 10 mg intravenously. Grade 2 Symptoms require and respond to moderate intervention.
Dosage forms and strengths
3 DOSAGE FORMS AND STRENGTHS YESCARTA is available as a cell suspension for infusion. A single dose of YESCARTA contains 2 × 10 6 CAR-positive viable T cells per kg of body weight (or maximum of 2 × 10 8 CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL suspension in an infusion bag [see How Supplied/Storage and Handling (16) ] . YESCARTA is available as a cell suspension for infusion. ( 3 ) YESCARTA comprises a suspension of 2 × 10 6 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells in approximately 68 mL. ( 3 )
Contraindications
None. None. ( 4 )
Warnings and precautions
Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.3 ) Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.4 ) Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following YESCARTA infusion. Monitor complete blood counts. ( 5.5 ) Hypogammaglobulinemia: Monitor and provide replacement therapy. ( 5.6 ) Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA ( 5.7 ). In the event that a secondary malignancy occurs after treatment with YESCARTA, contact Kite at 1-844-454-KITE (5483). ( 5.7 ) 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system 1 ) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9% [see Adverse Reactions (6) ] . Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in Study 2, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in Study 1, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in Study 3, including ≥ Grade 3 CRS in 8% [see Adverse Reactions (6) ] . Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) [see Adverse Reactions (6) ]. The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in Study 2. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events (see Table 1 ) [see Clinical Trials Experience (6.1) ] , CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA [see Clinical Trials Experience (6.1) ] . Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities [See Neurologic Toxicities (5.2) ] . Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time [see Patient Counseling Information (17) ] . At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated [see Dosage and Administration (2.3) ] . 5.2 Neurologic Toxicities Neurologic toxicities (including ICANS) that were fatal or life-threatening occurred following treatment with YESCARTA. Neurologic toxicities occurred in 78% (330/422) of patients with NHL (excluding central nervous system lymphoma) receiving YESCARTA, including ≥ Grade 3 cases in 25% in Study 1, Study 2, and Study 3. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in Study 2, including ≥ Grade 3 cases in 31% and in 74% (124/168) of patients in Study 1 including ≥ Grade 3 cases in 25%. The median time to onset was 4 days (range: 1 to 43 days) and the median duration was 17 days in patients with LBCL in Study 2. The median time to onset for neurologic toxicity was 5 days (range:1 to 133 days) and median duration was 15 days in patients with LBCL in Study 1. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1 to 79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of YESCARTA infusion in 87% of affected patients with LBCL and 74% of affected patients with iNHL.
Side effects
The most common adverse reactions (incidence ≥ 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. ( 6.1 ) The most common Grade 3-4 laboratory abnormalities (≥ 30%) are leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia, and hypophosphatemia. ( 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. The safety data described in the WARNINGS AND PRECAUTIONS and in the ADVERSE REACTIONS sections reflect exposure to a single dose of YESCARTA in four clinical studies, including 168 patients with relapsed or refractory LBCL (Study 1), 108 patients with relapsed or refractory LBCL (Study 2), 146 patients with relapsed or refractory iNHL (including 124 with FL; Study 3), and 13 patients with relapsed or refractory primary CNS lymphoma (PCNSL) (Study 4). Relapsed or Refractory Large B-cell Lymphoma Study 1 The safety of YESCARTA was evaluated in Study 1, a randomized, open-label, multicenter study in which patients with primary refractory LBCL or first relapse of LBCL received YESCARTA (N = 168) or standard therapy (N = 168) [see Clinical Studies (14) ] . Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous HSCT. The trial excluded patients who were not deemed candidates for transplant or who had a history of central nervous system (CNS) disorders (such as seizures or cerebrovascular ischemia), serious or uncontrolled infection, or autoimmune disease requiring systemic immunosuppression. The study required ANC ≥ 1000/mm 3 , platelet count ≥ 75,000/mm 3 , creatinine clearance ≥ 60 ml/min, AST/ALT ≤ 2.5 × ULN, and total bilirubin ≤ 1.5 mg/dL. The median age of the YESCARTA-treated safety population was 59 years (range: 21 to 80 years); 62% were male. The baseline Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 54% of patients and 1 in 46%. Serious adverse reactions occurred in 50% of patients. The most common serious adverse reactions (> 5%) included CRS, fever, encephalopathy, hypotension, infection with unspecified pathogen, and pneumonia. Fatal adverse reactions occurred in 2% of patients. Sixty-seven percent (112/168) of patients received tocilizumab after infusion of YESCARTA. Table 3 summarizes selected non-laboratory adverse reactions in patients treated with YESCARTA, and Table 4 summarizes selected new or worsening Grade 3 or 4 laboratory abnormalities. Table 3. Adverse Reactions in ≥ 10% of Patients with Relapsed or Refractory LBCL in Study 1 Adverse Reaction YESCARTA N = 168 Any Grade (%) Grade 3 or Higher (%) Blood and Lymphatic System Disorder Febrile neutropenia 31 31 Cardiac Disorders Tachycardia Represents a composite of multiple, related preferred terms. 43 2 Arrhythmia 14 3 Gastrointestinal Disorders Diarrhea Diarrhea includes diarrhea, colitis. 42 3 Nausea 40 2 Abdominal pain 20 4 Constipation 20 0 Vomiting 20 0 Dry Mouth 10 0 General Disorders and Administration Site Conditions Fever 93 9 Fatigue 52 7 Chills 28 1 Edema 23 1 Immune System Disorders Cytokine release syndrome CRS includes coagulopathy, tachycardia, arrhythmia, cardiac failure, diarrhea, nausea, vomiting, fever, fatigue, chills, edema, decreased appetite, musculoskeletal pain, headache, tremor, dizziness, renal insufficiency, cough, hypoxia, dyspnea, pleural effusion, respiratory failure, rash, hypotension, and hypertension. 92 7 Hypogammaglobulinemia 11 0 Infections and Infestations Infections with pathogen unspecified 25 8 Viral infections 15 4 Bacterial infections 10 5 Fungal infections 10 1 Metabolism and Nutrition Disorders Decreased appetite 24 4 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain 40 1 Motor dysfunction Motor dysfunction includes muscle contractions involuntary, muscle spasms, muscle twitching, muscular weakness. 15 4 Nervous System Disorders Encephalopathy Encephalopathy includes encephalopathy, altered state of consciousness, amnesia, apraxia, bradyphrenia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, dyspraxia, lethargy, loss of consciousness, memory impairment, mental impairment, mental status changes, metabolic encephalopathy, slow speech, somnolence, toxic encephalopathy. 46 18 Headache 41 3 Tremor 25 1 Dizziness 25 4 Aphasia 20 7 Neuropathy peripheral 11 2 Psychiatric Disorders Insomnia 13 0 Delirium Delirium includes delirium, agitation, delusion, disorientation, hallucination, irritability, restlessness. 12 4 Renal and Urinary Disorders Renal insufficiency 11 2 Respiratory, Thoracic and Mediastinal Disorders Cough 27 1 Hypoxia 21 9 Skin and Subcutaneous Tissue Disorders Rash 17 1 Vascular Disorders Hypotension 47 11 Other clinically important adverse reactions that occurred in less than 10% of patients treated with YESCARTA include the following: Blood and lymphatic system disorders: Coagulopathy (9%) Cardiac disorders: Cardiac failure (1%) Eye Disorders: Visual impairment (7%) Infections and infestations: Pneumonia (8%), Sepsis (4%) Nervous system disorders: Ataxia (6%), seizure (3%), myoclonus (2%), facial paralysis (2%), paresis (2%) Respiratory, thoracic and mediastinal disorders: Dyspnea (8%), pleural effusion (6%), respiratory failure (2%) Vascular disorders: Hypertension (9%), thrombosis (7%) Laboratory abnormalities: Table 4.
Use in specific populations
8.1 Pregnancy Risk Summary There are no available data with YESCARTA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with YESCARTA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if YESCARTA has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, YESCARTA is not recommended for women who are pregnant, and pregnancy after YESCARTA infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of YESCARTA in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YESCARTA and any potential adverse effects on the breastfed infant from YESCARTA or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Pregnancy status of females with reproductive potential should be verified. Sexually active females of reproductive potential should have a pregnancy test prior to starting treatment with YESCARTA. Contraception See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with YESCARTA. Infertility There are no data on the effect of YESCARTA on fertility. 8.4 Pediatric Use The safety and efficacy of YESCARTA have not been established in pediatric patients. 8.5 Geriatric Use Of the 422 patients with NHL who received YESCARTA in clinical trials, 127 patients (30%) were 65 years of age and older. No clinically important differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data with YESCARTA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with YESCARTA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if YESCARTA has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, YESCARTA is not recommended for women who are pregnant, and pregnancy after YESCARTA infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively.
Pediatric use
8.4 Pediatric Use The safety and efficacy of YESCARTA have not been established in pediatric patients.
Geriatric use
8.5 Geriatric Use Of the 422 patients with NHL who received YESCARTA in clinical trials, 127 patients (30%) were 65 years of age and older. No clinically important differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients.
Description
(axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare YESCARTA, a patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains. The anti-CD19 CAR T cells are expanded and infused back into the patient, where they can recognize and eliminate CD19-expressing target cells. YESCARTA is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells and activated with anti-CD3 antibody in the presence of IL-2, then transduced with the replication incompetent retroviral vector containing the anti-CD19 CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag. The product is thawed prior to infusion [see Dosage and Administration (2.2) , How Supplied/Storage and Handling (16) ]. In addition to T cells, YESCARTA may contain NK and NK-T cells. The formulation contains 5% dimethyl sulfoxide (DMSO) and 2.5% albumin (human).
Mechanism of action
12.1 Mechanism of Action YESCARTA, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING YESCARTA is supplied in an infusion bag (NDC 71287-119-01) containing approximately 68 mL of frozen suspension of genetically modified autologous T cells in 5% DMSO and 2.5% albumin (human). Each YESCARTA infusion bag is individually packed in a metal cassette (NDC 71287-119-02). YESCARTA is supplied in a liquid nitrogen dry shipper at ≤ -150°C. Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt. At the treatment center, store YESCARTA frozen at ≤ -120°C (in a mechanical freezer or in the vapor phase of liquid nitrogen) up to the labeled expiration date. YESCARTA may be transferred from vapor phase of liquid nitrogen to mechanical freezer storage at ≤ -120°C only once and cannot be transferred back. YESCARTA may be stored at the treatment center for a single time at -80°C (+/- 10°C), for up to 90 days, and not exceeding the labeled expiration date. Do not return YESCARTA to storage at ≤ -120°C after storage at - 80°C. Thaw before using [see Dosage and Administration (2) ].
Storage
Each YESCARTA infusion bag is individually packed in a metal cassette (NDC 71287-119-02). YESCARTA is supplied in a liquid nitrogen dry shipper at ≤ -150°C. Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt. At the treatment center, store YESCARTA frozen at ≤ -120°C (in a mechanical freezer or in the vapor phase of liquid nitrogen) up to the labeled expiration date. YESCARTA may be transferred from vapor phase of liquid nitrogen to mechanical freezer storage at ≤ -120°C only once and cannot be transferred back. YESCARTA may be stored at the treatment center for a single time at -80°C (+/- 10°C), for up to 90 days, and not exceeding the labeled expiration date. Do not return YESCARTA to storage at ≤ -120°C after storage at - 80°C. Thaw before using [see Dosage and Administration (2) ].
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Ensure that patients understand the risk of manufacturing failure (< 1% in clinical trials). In case of a manufacturing failure, a second manufacturing of YESCARTA may be attempted. In addition, while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period. Advise patients to seek immediate attention for any of the following: Cytokine Release Syndrome (CRS) - Signs or symptoms associated with CRS, including fever, chills, fatigue, tachycardia, nausea, hypoxia, and hypotension [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Neurologic Toxicities - Signs or symptoms associated with neurologic events, including encephalopathy, seizures, changes in level of consciousness, speech disorders, tremors, and confusion [see Warnings and Precautions (5.2) and Adverse Reactions (6) ] . Serious Infections - Signs or symptoms associated with infection [see Warnings and Precautions (5.4) and Adverse Reactions (6) ] . Prolonged Cytopenia - Signs or symptoms associated with bone marrow suppression, including neutropenia, anemia, thrombocytopenia, or febrile neutropenia [see Warnings and Precautions (5.5) and Adverse Reactions (6) ] . Secondary Malignancies - Secondary malignancies, including T cell malignancies, have occurred [see Boxed Warning , Warnings and Precautions (5.7) , and Adverse Reactions (6.3) ] . Advise patients of the need to: Avoid driving for at least 2 weeks. Have periodic monitoring of blood counts. Contact Kite at 1-844-454-KITE (5483) if they are diagnosed with a secondary malignancy [see Warnings and Precautions (5.7) ] .
Label text from the FDA structured product label by Kite Pharma, Inc. (revised Aug 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Axicabtagene Ciloleucel in 1 product
Yescarta NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 71287-119 | Axicabtagene Ciloleucel 2000000 1/68mL Suspension | Kite Pharma, Inc. | BLA |
Frequently asked questions
What is Yescarta used for?
1 INDICATIONS AND USAGE YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of…
What are the side effects of Yescarta?
The most common adverse reactions (incidence ≥ 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. ( 6.1 ) The most common Grade 3-4 laboratory abnormalities (≥… See the full label for the complete list.
Who makes Yescarta?
Yescarta is listed by 1 labeler in the FDA NDC directory, including Kite Pharma, Inc..