Approved Risk Evaluation and Mitigation Strategies (REMS)

Breyanzi ((lisocabtagene maraleucel))

BLA #125714

REMS last update: 02/05/2021

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

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

Ensuring that hospitals and associated clinics that dispense BREYANZI are specially certified and have on-site immediate access to tocilizumab.
Ensuring that those who prescribe, dispense, or administer BREYANZI 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 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). Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program requirements on behalf of the hospital and associated clinic(s). Have the authorized representative complete the Live Training Program provided by the REMS Program \| Training Program \| Have the authorized representative successfully complete the Knowledge Assessment and submit it to the REMS Program. \| Knowledge Assessment \| Have the authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form and submitting it to the REMS Program. Train all relevant staff involved in prescribing, dispensing, or administering of BREYANZI on the REMS Program requirements using the Live Training Program. Have all relevant staff involved in prescribing, dispensing, or administering of BREYANZI successfully complete the Knowledge Assessment and submit it to the REMS Program. Establish processes and procedures to ensure relevant new staff involved in the prescribing, dispensing, or administration of BREYANZI are trained and complete the Knowledge Assessment and submit it to the REMS Program. 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	Provide the patient with the Patient Wallet Card \| 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 if there is a change in authorized representative	Have a new Authorized Representative enroll in the REMS Program by completing the Hospital Enrollment Form. \| Hospital Enrollment Form \|
To maintain certification to dispense, if BREYANZI 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 BREYANZI on the REMS Program requirements using the Live Training Program. \| Training Program \| Have all relevant staff involved in prescribing, dispensing, or administering of BREYANZI 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 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 training, processes, and procedures are in place and are being followed.

Patients who are prescribed BREYANZI:

Before infusion

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
Hospital Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Hospital_Enrollment_Form.pdf
Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Knowledge_Assessment.pdf
Patient Wallet Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Document.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Website_Screenshots.pdf
Training Program (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Training_Program.pdf

What updates have been made to the REMS?

Date	Summary of change
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.

Breyanzi ((lisocabtagene maraleucel)) BLA #125714 REMS last update: 02/05/2021