facts [40%:10%: Cardiovascular: Hypotension (57%), tachycardia (57%), cardiac arrhythmia (23%), edema (19%), hypertension (15%), thrombosis (10%), cardiac failure (6%), capillary leak syndrome (3%) Central nervous system: Brain disease (57%; lasted up to 173 days), fatigue (46%), headache (44% to 45%), chills (40%), dizziness (21%), motor dysfunction (19%), aphasia (18%), delirium (17%) Endocrine & metabolic: Hypophosphatemia (grade 3 or 4: 50%), hyponatremia (grade 3 or 4: 19%), weight loss (16%), increased uric acid (grade 3 or 4: 13%), dehydration (11%) Gastrointestinal: Decreased appetite (44%), diarrhea (38%), nausea (34%), vomiting (26%), constipation (23%), abdominal pain (14%), xerostomia (11%) Hematologic & oncologic: Lymphocytopenia (grade 3 or 4: 100%), leukopenia (grade 3 or 4: 96%), neutropenia (grade 3 or 4: 93%), anemia (grade 3 or 4: 66%), thrombocytopenia (grade 3 or 4: 58%), febrile neutropenia (36%), hypogammaglobulinemia (15%) Hepatic: Increased direct serum bilirubin (grade 3 or 4: 13%) Hypersensitivity: Cytokine release syndrome (94%) Infection: Infection (26%), viral infection (16%), bacterial infection (13%) Neuromuscular & skeletal: Tremor (31%), limb pain (17%), back pain (15%), myalgia (14%) Renal: Renal insufficiency (12%) Respiratory: Hypoxia (32%), cough (30%), dyspnea (19%), pleural effusion (13%) Miscellaneous: Fever (86%) 1% to 10%: Central nervous system: Anxiety (9%), insomnia (9%), ataxia (6%), seizure (4%), cognitive dysfunction (comprehending mathematics: 2%), myoclonus (2%) Dermatologic: Skin rash (9%) Endocrine & metabolic: Hypokalemia (grade 3 or 4: 10%) Genitourinary: Urinary tract infection (>2%) Hematologic & oncologic: Blood coagulation disorder (2%), natural killer cell count increased (hemophagocytic lymphohistiocytosis/macrophage activation syndrome: 1%) Hepatic: Increased serum ALT (grade 3 or 4: 10%) Hypersensitivity: Hypersensitivity reaction (1%) Infection: Fungal infection (5%), clostridium infection (>2%) Neuromuscular & skeletal: Arthralgia (10%) Respiratory: Pulmonary edema (9%), pulmonary infection (>2%) Frequency not defined: Central nervous system: Cerebral edema, leukoencephalopathy, seizure ALERT: U.S. Boxed Warning Cytokine release syndrome: Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel. Do not administer axicabtagene ciloleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurological toxicities: Neurological toxicities, including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with axicabtagene ciloleucel. Provide supportive care and/or corticosteroids as needed. REMS program: Axicabtagene ciloleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA REMS. Warnings/Precautions Concerns related to adverse effects: Cytokine release syndrome : [US Boxed Warning]: Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel. Do not administer axicabtagene ciloleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Grade 3 or 4 CRS reactions have occurred. The median time to onset of CRS was 2 days (range: 1 to 12 days); the median duration of CRS was 7 days (range: 2 to 58 days). Key manifestations of CRS include fever, hypotension, tachycardia, hypoxia, and chills. Cardiac arrhythmias (eg, atrial fibrillation, ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) may be associated with CRS (may be serious). Ensure that tocilizumab is available (a minimum of 2 doses) on site prior to axicabtagene ciloleucel infusion. Monitor for signs or symptoms of CRS for at least 4 weeks after treatment (daily for 7 days following the infusion) . Patients should seek immediate medical attention if signs or symptoms of CRS occur at any time. Evaluate patients immediately at the first sign of CRS; hospitalize and begin supportive care, tocilizumab, and/or corticosteroids as indicated. Cytopenias: Prolonged cytopenias may occur several weeks after lymphodepleting chemotherapy and axicabtagene ciloleucel infusion. Unresolved (by day 30 following axicabtagene ciloleucel treatment) grade 3 and 4 cytopenias included neutropenia, thrombocytopenia, and anemia. Monitor blood counts during and after treatment. Hepatitis B virus reactivation: Hepatitis B virus (HBV) reactivation (sometimes resulting in fulminant hepatitis, hepatic failure, and death) can occur in patients treated with medications directed against B cells. Hepatitis has been reported in patients who are hepatitis B surface antigen (HBsAg) positive, and in patients who are HBsAg-negative but are hepatitis B core antibody (anti-HBc) positive. HBV reactivation has occurred in patients who appear to have resolved hepatitis B infection (HBsAg-negative, anti-HBc-positive, and hepatitis B surface antibody [anti-HBs] positive). HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg-negative and anti-HBc-positive. Reactivation of HBV replication is often followed by hepatitis (increased transaminase levels). Increased bilirubin levels, liver failure, and death can occur in severe cases. Screen for HBV, HCV, and HIV in accordance with clinical guidelines prior to collection of cells for manufacturing. Hypersensitivity: Allergic reactions may occur with axicabtagene ciloleucel infusion. Serious hypersensitivity reactions, including anaphylaxis, may occur due to the dimethyl sulfoxide (DMSO) or residual gentamicin in axicabtagene ciloleucel. Hypogammaglobulinemia: Hypogammaglobulinemia and B-cell aplasia may occur in patients receiving axicabtagene ciloleucel. Monitor immunoglobulin levels after axicabtagene ciloleucel treatment. Manage hypogammaglobulinemia with infection precautions, antibiotic prophylaxis, and immunoglobulin treatment (per standard replacement guidelines). Infection: Serious infections (including life-threatening or fatal infections) occurred in patients after axicabtagene ciloleucel infusion, including grades 3 and 4 infections in close to one-quarter of patients. Viral and bacterial infections were reported as well as infections due to unknown pathogens. Begin prophylaxis according to local guidelines prior to axicabtagene ciloleucel infusion. Monitor for signs and symptoms of infection before and following treatment and manage appropriately; do not administer to patients with clinically significant active systemic infections. Neutropenic fever (grade 3 or 4) has been observed after axicabtagene ciloleucel infusion and may occur concurrently with CRS. If neutropenic fever occurs, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as clinically indicated. Neurological toxicities: [US Boxed Warning]: Neurological toxicities, including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel, including concurrently with CRS or after CRS resolution. Monitor for neurological toxicities after treatment with axicabtagene ciloleucel. Provide supportive care and/or corticosteroids as needed. Most neurological toxicities occurred within 8 weeks following axicabtagene ciloleucel infusion; the median time to onset was 4 days (range: 1 to 43 days). The median duration of neurologic toxicities was 17 days. Grade 3 or higher neurologic toxicities have been observed in close to one-third of patients. The most common neurological toxicities were encephalopathy, headache, tremor, dizziness, aphasia, delirium, insomnia, and anxiety. Prolonged encephalopathy (lasting up to 173 days) was observed. Fatal and serious cases of cerebral edema have occurred; other serious events included leukoencephalopathy and seizures. Monitor for signs or symptoms of neurologic toxicities for at least 4 weeks after treatment (daily for 7 days following the infusion) . Treat promptly if neurologic toxicities occur. Due to the potential for neurologic events, including altered mental status or seizures, patients receiving axicabtagene ciloleucel are at risk for altered or decreased consciousness or coordination in the 8 weeks following administration; during this initial period, advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery. Secondary malignancy: Patients treated with axicabtagene ciloleucel may develop secondary malignancies or leukemia recurrence. Monitor permanently for secondary malignancies. If a secondary malignancy occurs, contact the manufacturer (1-844-454-KITE) to obtain patient sampling instructions for testing. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Immunizations: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during axicabtagene ciloleucel treatment, and until immune recovery following treatment. The safety of immunization with live viral vaccines during or following axicabtagene ciloleucel treatment has not been studied. Other warnings/precautions: Appropriate use: For autologous use only. Confirm patient identity and match to patient identifiers on the cassette and infusion bag prior to infusion. Administer in a health care facility; patients should remain within proximity of the facility for at least 4 weeks after infusion. REMS program: [US Boxed Warning]: Axicabtagene ciloleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA REMS. Information is available at www.YescartaREMS.com or 1-844-454-5483. Monitoring Parameters Screen for HBV, HCV, and HIV (prior to collection of cells for manufacturing). Monitor immunoglobulin levels and blood counts (after treatment). Pregnancy testing is recommended prior to therapy (in sexually active women of reproductive potential). Monitor for signs/symptoms of CRS and neurological toxicities for at least 4 weeks after treatment (monitor daily for the first 7 days after infusion at the health care facility), monitor for hypersensitivity reactions and for signs/symptoms of infection. Monitor (life-long) for secondary malignancies. Pregnancy Considerations Animal reproduction studies have not been conducted. Treatment with axicabtagene ciloleucel is not recommended during pregnancy. If placental transfer were to occur, fetal toxicity, including B-cell lymphocytopenia, may occur. Pregnancy testing is recommended prior to therapy in sexually active women of reproductive potential. Refer to the cyclophosphamide and fludarabine monographs for information related to use of effective contraception in patients using these medications for lymphodepleting chemotherapy. The duration of contraception needed following axicabtagene ciloleucel administration is not known. 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