Approved Risk Evaluation and Mitigation Strategies (REMS)

Kymriah (tisagenlecleucel)
BLA #125646
REMS last update: 06/20/2019



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

Hospitals and their associated clinics that dispense Kymriah must

To become certified to dispense
  • Have a minimum of two doses of tocilizumab available on-site for each patient for immediate administration (within 2 hours).
  • Designate an authorized representative to carry out the certification process and oversee the implementation and compliance with the REMS Program on behalf of the hospital and their associated clinics.
  • Have the authorized representative complete the Live Training Program.
  • Have the authorized representative successfully complete the Knowledge Assessment and submit it to the REMS Program.
  • Have the authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form.
  • Train all relevant staff involved in prescribing, dispensing, or administering of Kymriah on the REMS program requirements using the Live Training Program.
  • Have all relevant staff involved in prescribing, dispensing, or administering successfully complete the Knowledge Assessment.
  • Establish processes and procedures to ensure new staff involved in the prescribing, dispensing, or administration of the Kymriah are trained.
  • Establish processes and procedures to verify that a minimum of two doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within 2 hours).
  • Establish processes and procedures to provide patients and their guardians with the Patient Wallet Card.
Before infusion
  • Provide the patient and their guardian with the Patient Wallet Card.
  • Verify that a minimum of two doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within 2 hours) through the processes and procedures established as a requirement of the REMS Program.
To maintain certification to dispense
  • Have the new authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form
To maintain certification to dispense, if Kymriah has not been dispensed at least once annually from the date of certification in the REMS program
  • Train all relevant staff involved in prescribing, dispensing, or administering of the Kymriah on the REMS program requirements using the Live Training Program.
  • Have all relevant staff involved in prescribing, dispensing, or adminstering successfully complete the Knowledge Assessment.
At all times
  • Report any adverse events suggestive of cytokine release syndrome or neurological toxicities.
  • Maintain records of staff training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits carried out by Novartis or a third party acting on behalf of Novartis to ensure that all processes and procedures are in place and are being followed.

Patients who are prescribed Kymriah

Before infusion
  • Receive the Patient Wallet Card

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Kymriah REMS, see the DailyMed link(s).
Material Name Material Name Link
Hospital Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Hospital_Enrollment_Form.pdf
Live Training Program Slides (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Live_Training_Program_Slides.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Patient_Wallet_Card.pdf
Program Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Program_Knowledge_Assessment.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
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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