LET ’ S BE CLEAR …
EVERY PATIENT SHOULD BE COUNTED . ARE YOU FAMILIAR WITH THE IMPORTANCE OF INTENT-TO-TREAT ( ITT ) DATA ?
PATIENTS DESERVE TO BE TREATED . DO YOU THINK ABOUT MANUFACTURING STATISTICS WHEN CONSIDERING TREATMENT OPTIONS ?
CONSIDER ALL THE DATA .
LEARN MORE ABOUT OUR ITT AND MANUFACTURING DATA , AND FIND AN AUTHORIZED TREATMENT CENTER FOR EARLY CONSULT AT YESCARTAHCP . COM
IMPORTANT SAFETY INFORMATION ( continued )
REMS : Because of the risk of CRS and neurologic toxicities , YESCARTA ® is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that : Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site , immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion , if needed for treatment of CRS . Certified healthcare facilities must ensure that healthcare providers who prescribe , dispense , or administer YESCARTA are trained about the management of CRS and neurologic toxicities . Further information is available at www . YescartaTecartusREMS . com or 1-844-454-KITE ( 5483 ).
HYPERSENSITIVITY REACTIONS : Allergic reactions , including serious hypersensitivity reactions or anaphylaxis , may occur with the infusion of YESCARTA .
SERIOUS INFECTIONS : Severe or life-threatening infections occurred . Infections ( all grades ) occurred in 38 % of patients . Grade ≥3 infections occurred in 23 % of patients ; those due to an unspecified pathogen occurred in 16 % of patients , bacterial infections in 9 %, and viral infections in 4 %. YESCARTA should not be administered to patients with clinically significant active systemic infections . Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately . Administer prophylactic anti-microbials according to local guidelines . Febrile neutropenia was observed in 36 % of patients and may be concurrent with CRS . In the event of febrile neutropenia , evaluate for infection and manage with broad spectrum antibiotics , fluids , and other supportive care as medically indicated . Hepatitis B virus ( HBV ) reactivation , in some cases resulting in fulminant hepatitis , hepatic failure , and death , can occur in patients treated with drugs directed against B cells . Perform screening for HBV , HCV , and HIV in accordance with clinical guidelines before collection of cells for manufacturing .
PROLONGED CYTOPENIAS : Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion . Grade ≥3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 28 % of patients and included thrombocytopenia ( 18 %), neutropenia ( 15 %), and anemia ( 3 %). Monitor blood counts after infusion .
HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur . Hypogammaglobulinemia occurred in 15 % of patients . Monitor immunoglobulin levels after treatment and manage using infection precautions , antibiotic prophylaxis , and immunoglobulin replacement . The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied . Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy , during YESCARTA treatment , and until immune recovery following treatment .
SECONDARY MALIGNANCIES may develop . Monitor life-long for secondary malignancies . In the event that one occurs , contact Kite at 1-844-454-KITE ( 5483 ) to obtain instructions on patient samples to collect for testing .
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES : Due to the potential for neurologic events , including altered mental status or seizures , patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion . Advise patients to refrain from driving and engaging in hazardous occupations or activities , such as operating heavy or potentially dangerous machinery , during this initial period .
ADVERSE REACTIONS : The most common ( incidence ≥20 %) include CRS , fever , hypotension , encephalopathy , tachycardia , fatigue , headache , decreased appetite , chills , diarrhea , febrile neutropenia , infections-pathogen unspecified , nausea , hypoxia , tremor , cough , vomiting , dizziness , constipation , and cardiac arrhythmias .
Please see Brief Summary of Prescribing Information , including BOXED WARNING and Medication Guide , on following pages .
CAR T = chimeric antigen receptor therapy ; CR = complete remission ; CRS = cytokine release syndrome ; DOR = duration of response ; IRC = independent review committee ; ORR = overall response rate ; OS = overall survival .
References : 1 . YESCARTA ® ( axicabtagene ciloleucel ). Prescribing Information . Kite Pharma , Inc ; 2020 . 2 . Locke FL , Ghobadi A , Jacobson CA , et al . Durability of response in ZUMA-1 , the pivotal phase 2 study of axicabtagene ciloleucel ( Axi-Cel ) in patients ( Pts ) with refractory large B-cell lymphoma . Presented at : 2018 ASCO Annual Meeting ; June 1-5 , 2018 ; Chicago , IL . Abstract 3003 . 3 . Neelapu SS , Rossi JM , Jacobson CA , et al . CD19-loss with preservation of other B cell lineage features in patients with large B cell lymphoma who relapsed post-axi-cel . Presented at : 61st ASH Annual Meeting and Exposition ; December 7-10 , 2019 ; Orlando , FL . Abstract 203 . 4 . Locke FL , Ghobadi A , Jacobson CA , et al . Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma ( ZUMA-1 ): a single-arm , multicentre , phase 1-2 trial . Lancet
Oncol . 2019 ; 20 ( 1 ): 31-42 . 5 . Data on file . Kite Pharma , Inc ; 2019 . 6 . Data on file . Kite Pharma , Inc ; 2018 . 7 . Data on file . Kite Pharma , Inc ; 2020 .
YESCARTA , the YESCARTA Logo , TECARTUS , KITE , and the KITE Logo are trademarks of Kite Pharma , Inc . GILEAD is a trademark of Gilead Sciences , Inc . All other trademarks referenced herein are the property of their respective owners . © 2020 Kite Pharma , Inc . All rights reserved . | YESP0869 10 / 2020