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Approved Risk Evaluation and Mitigation Strategies (REMS)

Kymriah (tisagenlecleucel)
BLA #125646
REMS last update: 05/27/2022



What is the purpose of the REMS?

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

  1. Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.
  2. Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
05/27/2022 Modified to make changes to the REMS Patient Wallet Card, Live Training Program, Knowledge Assessment, and REMS Program Website to align with labeling changes related to the new indication for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
06/11/2021 Modified to revise the REMS Training Slides and REMS Program website screenshots to align with the revisions to the USPI based on updated clinical trial safety data for CRS and neurologic toxicity.
06/20/2019 Modified to update the REMS Training Slides, to include flat dosing guidelines for high dose vasopressors and relevant references, and minor edits to clarify the signs and symptoms of cytokine release syndrome (CRS). To better align with the REMS Document, the Hospital Enrollment form and REMS Supporting Document were updated to clarify the reporting of adverse events related to CRS and neurotoxicity.
05/01/2018 Modified REMS training material to align with labeling changes related to the new indication and update the REMS Document to the new format.
08/30/2017 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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