Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Yescarta (axicabtagene ciloleucel)
BLA #125643
REMS last update: 04/19/2019



What is the purpose of the REMS?

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

  1. Ensuring that hospitals and their associated clinics that dispense YESCARTA are specially certified and have on-site, immediate access to tocilizumab.
  2. Ensuring those who prescribe, dispense, or administer YESCARTA are aware of how to manage the risks of CRS 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 Yescarta must

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

Patients who are prescribed Yescarta

Before treatment initiation
  • 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 Yescarta REMS, see the DailyMed link(s).
Material Name Material Name Link
Adverse Reaction Management Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_04_19_Adverse Reaction Management Guide.pdf
Hospital Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 Hospital Enrollment Form.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019-04_19_Knowledge Assessment.pdf
Live Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_04-19 Live Training.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 Patient Wallet Card.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 REMS Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 REMS Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 REMS Website Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
04/19/2019 Modified to clarify the severity of adverse events (AEs) suggestive of cytokine release syndrome (CRS) and neurological toxicities that must be reported and to change the timing of distribution of the Patient Wallet Card to the patient. These modifications resulted in corresponding updates to the REMS materials.
10/18/2017 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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