Risk Evaluation and Mitigation Strategy

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 the risks. The FDA has required a REMS for Kymriah^® (tisagenlecleucel).

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.
 
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH.
 
KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.

The goal of the Kymriah^® REMS is 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.

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.
 
You are encouraged to report suspected adverse events with Kymriah to Novartis at www.report.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.

Kymriah is a CD19-directed genetically modified autologous T Cell immunotherapy indicated for the treatment of:

• Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

• Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
  Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma.

• Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).