Risk Evaluation and Mitigation Strategy

(REMS)

REMS Safety Information

A Risk Evaluation and Mitigation Strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. The FDA has required a REMS for Kymriah® (tisagenlecleucel).

 

BOXED 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 or tocilizumab and corticosteroids.

 

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.

 

KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS. 

 

Goals of the REMS

 

The goals of the Kymriah® (tisagenlecleucel) REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:

 

  • Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.

  • Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities. 

 

Kymriah is only available at select treatment centers.  For more information, please call the REMS Call Center at 1-844-4KYMRIAH (1-844-459-6742).

 

To learn more about Kymriah and its serious risks and clinical manifestations, read the Prescribing Information and the Medication Guide.

 

The Kymriah REMS Program Patient Wallet Card (English and Spanish), the Kymriah REMS Live Training Program Slides, and Kymriah REMS Program Knowledge Assessment can be ordered through the REMS Call Center at 1-844-4KYMRIAH (1-844-459-6742).

 

You are encouraged to report suspected adverse events with Kymriah to Novartis at https://psi.novartis.com or 1‑888‑669‑6682 or the FDA at www.fda.gov/medwatch or 1-800-FDA-1088

 

Continue to check back on this website; it will be updated to include additional or new information intended to assist in the proper communication of the serious risks associated with Kymriah.