Approved Risk Evaluation and Mitigation Strategies (REMS)
Breyanzi ((lisocabtagene maraleucel))
BLA #125714
REMS last update: 02/05/2021
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 |
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Before infusion |
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To maintain certification to dispense if there is a change in authorized representative |
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To maintain certification to dispense, if BREYANZI has not been dispensed at least once annually from the date of certification in the REMS Program |
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At all times |
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Patients who are prescribed BREYANZI:
Before infusion |
|
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.
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