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The goals of the ABECMA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurologic toxicities by:
Ensuring that hospitals and their associated clinics that dispense ABECMA 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). See the application holder(s) REMS Website or the approved REMS materials for more information.
Hospitals and their associated clinics that dispense ABECMA 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.
| Hospital Enrollment Form |
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 onsite
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.
| 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 Celgene Corporation or a third
party acting on behalf of Celgene Corporation to ensure that all
processes and procedures are in place and are being followed.
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. For a specific Medication Guide of a product in the Abecma REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
04/04/2024
Modified to to minimize the burden on the healthcare delivery system of complying with the REMS.
04/20/2021
Modified to update the REMS materials to align with the final label.
03/26/2021
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.