Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Yescarta and Tecartus (axicabtagene ciloleucel)

BLA #125703 BLA #125643

REMS last update: 04/01/2022

• View the Yescarta and Tecartus Prescribing Information at DailyMed
• View Yescarta and Tecartus's Regulatory Information at Drugs@FDA
• View the Yescarta and Tecartus Prescribing Information and Medication Guide at DailyMed.
• View Yescarta and Tecartus's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goals of the YESCARTA and TECARTUS 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 and/or TECARTUS are specially certified and have on-site, immediate access to tocilizumab
2. Ensuring those who prescribe, dispense, or administer YESCARTA and/or TECARTUS 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

Hospitals and their associated clinics that dispense Yescarta and/or Tecartus 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 complete the certification process and oversee implementation and compliance with the REMS Program requirements on behalf of the hospital and its associated clinics. Have the authorized representative enroll in the REMS by completing the Hospital Enrollment Form and submitting it to the REMS Program. | Hospital Enrollment Form | Have the authorized representative complete the Program Training. | Program Training | Have the authorized representative successfully complete a Knowledge Assessment and submit it to the REMS Program. | Knowledge Assessment | Train all relevant staff involved in prescribing, dispensing, or administering of Yescarta and/or Tecartus on the REMS Program requirements using the Program Training and Adverse Reaction Management Guide. | Program Training | | Adverse Reaction Management Guide | Have all relevant staff involved in prescribing, dispensing, or administering Yescarta and/or Tecartus successfully complete the Knowledge Assessment. | Knowledge Assessment | Establish processes and procedures to ensure relevant new staff involved in prescribing, dispensing, or administering Yescarta and/or Tecartus are trained and complete the Knowledge Assessment. | Knowledge Assessment | 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 with the Patient Wallet Card. | Patient Wallet Card |
Before infusion	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.
Before discharge	Provide the patient with the Patient Wallet Card through the processes and procedures established as a requirement of the REMS Program. | Patient Wallet Card |
To maintain certification to dispense, if there is a change in authorized representative	Have the new authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form. | Hospital Enrollment Form |
To maintain certification to dispense, if Yescarta or Tecartus has not been dispensed at least once annually from the date of initial certification in the REMS Program	Train all relevant staff involved in prescribing, dispensing, or administering Yescarta and/or Tecartus on the REMS Program requirements using the Program Training. | Program Training | Have all relevant staff involved in prescribing, dispensing, or administering Yescarta and/or Tecartus successfully complete the Knowledge Assessment. | Knowledge Assessment |
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. Maintain documentation that all processes and procedures are in place and are being followed. Comply with audits by Kite Pharma, Inc. or a third party acting on behalf of Kite Pharma, Inc. to ensure that all training, processes, and procedures are in place and are being followed.

Patients who are dispensed Yescarta or Tecartus:

Before discharge

Receive the Patient Wallet Card. | 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.

Material Name	Material Name Link
Adverse Reaction Management Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Adverse_Reaction_Management_Guide.pdf
Hospital Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Hospital_Enrollment_Form.pdf
Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Knowledge_Assessment.pdf
Patient Wallet Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Patient_Wallet_Card.pdf
Program Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Program_Training.pdf
Program Website (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Program_Website.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_REMS_Full.pdf

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
04/01/2022	Modified to make changes to the REMS Program Training, REMS Knowledge Assessment, REMS Hospital Enrollment Form and REMS Website to align with labeling changes related to the new indication for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.
01/25/2022	Modified to update the U.S. Prescribing Information with clinical safety data from Cohort 6 of the Phase 2 Safety Management ZUMA-1 study.
10/04/2021	Modified to make changes to the REMS materials to align with the labeling changes related to the approval of the Tecartus efficacy sBLA STN 125703/91 for the addition of a new indication for adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL) as follows: Grammatical edits to YESCARTA and TECARTUS REMS Document Add information on the adverse events of cytokine release syndrome (CRS) and neurological toxicities in patients with r/r B-cell precursor ALL to the YESCARTA and TECARTUS REMS Website and REMS Program Training Modify the YESCARTA and TECARTUS REMS Knowledge Assessment to improve question clarity and incorporate information for CRS and neurological toxicities with r/r B-cell precursor ALL
07/14/2021	Modified the REMS Adverse Reaction Management Guide, REMS Program Training, and REMS Website to align with the approved U.S. Package Insert for Yescarta.
04/22/2021	Modified the REMS materials to align with labeling changes related to the approval of Yescarta for management of cytokine release syndrome and neurological toxicities as follows: Modify the management of cytokine release syndrome (CRS) and neurological toxicities in Yescarta and Tecartus Adverse Reaction Management Guide, REMS Training Program to align with the approved USPI based on results of Cohort 4 of the ZUMA-1 study. Add information on the results of Cohort 4 of the ZUMA-1 study to the REMS Training Program and the REMS WEbsite. Modify the Yescarta and Tecartus REMS Knowledge Assessment to reflect management of cytokine release syndrome (CRS) and neurological toxicities based on results of Cohort 4 of the ZUMA-1 study.
03/05/2021	Modified the REMS materials to align with labeling changes related to the approval of Yescarta for a new indication for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy as follows: Add information on the adverse events of cytokine release syndrome (CRS) and neurological toxicities in patients with indolent NHL (iNHL) to the Yescarta and Tecartus REMS Website and REMS Training Program. Modify the Yescarta and Tecartus REMS Knowledge Assessment to incorporate information for CRS and neurological toxicities with iNHL
12/09/2020	Modified to add a wallet card in Chinese and Spanish and updates to the Kite Pharma website indicating that there are wallet cards for non-English speakers.
07/24/2020	Modified due to the similar serious risks of CRS and neurological toxicities of YESCARTA and in order to minimize burden on the healthcare delivery system the REMS for YESCARTA and the REMS for TECARTUS have been merged into a single “YESCARTA and TECARTUS REMS” program.
11/12/2019	Modified to reflect minor revision to the Yescarta REMS Website requesting to report suspected serious adverse events associated with Yescarta.
08/02/2019	Modified to update REMS Materials to ensure they are aligned with the recently approved USPI (May 2019) and the recently approved major modification to the REMS for Yescarta (April 2019).
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.