Approved Risk Evaluation and Mitigation Strategies (REMS)

Breyanzi (lisocabtagene maraleucel)

BLA #125714

REMS last update: 05/30/2024

• View the Breyanzi Prescribing Information at DailyMed
• View Breyanzi's Regulatory Information at Drugs@FDA

• Goals
• Summary
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the BREYANZI REMS is to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:

1. Ensuring that hospitals and their associated clinics that dispense BREYANZI are specially certified and have on-site, immediate access to tocilizumab.

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).

View application holder(s) REMS Website

Hospitals and their associated clinics that dispense BREYANZI 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 of infusion). Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the hospital and associated clinic(s). Have the Authorized Representative enroll in the REMS by completing the Hospital Enrollment Form and submitting it to the REMS. 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 of infusion).
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 of infusion) through the processes and procedures established as a requirement of the REMS.
To maintain certification to dispense, if there is a change in authorized representative	Have a new Authorized Representative enroll in the REMS by completing the Hospital Enrollment Form.
At all times	Maintain records that processes and procedures are in place and are being followed. Comply with audits carried out by Juno Therapeutics, Inc., or a third party acting on behalf of Juno Therapeutics, Inc., to ensure that all processes and procedures are in place and are being followed.

Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date	Summary of change
05/30/2024	Modified to align the REMS website with labeling changes related to the new indication.
05/15/2024	Modified to align the REMS website with the U.S. package insert (USPI), and make editorial changes to improve clarity of the REMS materials.
03/14/2024	Modified to minimize the burden on the healthcare delivery system of complying with the REMS.
06/24/2022	Modified to change the Hospital Enrollment Form, REMS Patient Wallet Card, Live Training Program, Knowledge Assessment, and REMS Program Website to align with labeling changes related to the new indications, as well as editorial changes to the REMS Document.
02/05/2021	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.