INTRODUCING A NEW CAR T THERAPY
Find a list of authorized treatment centers at YESCARTA . com / centers
INDICATION
YESCARTA™ is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of 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 .
Limitation of Use : YESCARTA™ is not indicated for the treatment of patients with primary central nervous system lymphoma .
IMPORTANT SAFETY INFORMATION
WARNING : CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
• Cytokine Release Syndrome ( CRS ), including fatal or life-threatening reactions , occurred in patients receiving YESCARTA™ . Do not administer YESCARTA™ to patients with active infection or inflammatory disorders . Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [ see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 )].
• Neurologic toxicities , including fatal or life-threatening reactions , occurred in patients receiving YESCARTA™ , including concurrently with CRS or after CRS resolution . Monitor for neurologic toxicities after treatment with YESCARTA™ . Provide supportive care and / or corticosteroids as needed [ see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.2 )].
• YESCARTA™ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy ( REMS ) called the YESCARTA™ REMS [ see Warnings and Precautions ( 5.3 )].
Important Safety Information continued on adjacent page .
YESCARTA is a trademark of Kite Pharma . © 2017 Kite Pharma | PRC-00145 10 / 2017