ASH Clinical News ACN_4.1_FULL_ISSUE_DIGITAL | Page 70

For the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory or in second or later relapse .

Thank you to the dedicated health care professionals , patients , and families who played a crucial role in making KYMRIAH™ ( tisagenlecleucel ) a reality .

Visit KYMRIAH-hcp . com or call KYMRIAH CARES™ at 1-844-4KYMRIAH ( 1-844-459-6742 ) to learn more about KYMRIAH , including treatment center locations , coverage support , and patient assistance .

IMPORTANT SAFETY INFORMATION

WARNING : CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES

• Cytokine Release Syndrome ( CRS ), including fatal or life-threatening reactions , occurred in patients receiving KYMRIAH . Do not administer KYMRIAH to patients with active infection or inflammatory disorders . Treat severe or life-threatening CRS with tocilizumab [ see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 )].

• Neurological toxicities , which may be severe or life-threatening , can occur following treatment with KYMRIAH , including concurrently with CRS . Monitor for neurological events after treatment with KYMRIAH . Provide supportive care as needed [ see Warnings and Precautions ( 5.2 )].

• KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy ( REMS ) called the KYMRIAH REMS [ see Warnings and Precautions ( 5.3 )].

Please see additional Important Safety Information on next page . Please see Brief Summary of full Prescribing Information for KYMRIAH , including Boxed WARNING , on following pages .