ASH Clinical News ACN_3.13_FULL_ISSUE_DIGITAL | Page 54

Introducing the first FDA-approved
CAR-T cell therapy: CTL019 is now
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.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080
© 2017 Novartis
Printed in USA
9/17
KYM-1149820