Approved Risk Evaluation and Mitigation Strategies (REMS)
Elrexfio (elranatamab-bcmm)
BLA #761345
REMS last update: 12/13/2023
What is the purpose of the REMS?
The goal of the ELREXFIO REMS is to mitigate the risks of Cytokine Release Syndrome (CRS), and neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) by:
- Ensuring prescribers are aware of the importance of monitoring for signs and symptoms of CRS and neurologic toxicity including ICANS in patients exposed to ELREXFIO
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.
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 |
|---|---|
| 12/13/2023 | Modified to update the Healthcare Provider REMS Letter to specify time periods when the prescriber knowledge, attitude, and behavior (KAB) surveys will be conducted. |
| 08/14/2023 | 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.