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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.
Ensuring that those who prescribe, dispense, or administer ABECMA are aware of how to manage the risks of CRS and neurologic 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.
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).
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 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.
| Hospital Enrollment Form |
Train all relevant staff involved in prescribing, dispensing, or
administering of ABECMA on the REMS Program requirements using
the Training Program and Adverse Reaction Management Guide.
| Adverse Reaction Management Guide |
| Training Program |
Have all relevant staff involved in prescribing, dispensing, or
administering of ABECMA successfully complete the Knowledge
Assessment and submit it to the REMS Program.
| Knowledge Assessment |
Establish processes and procedures to ensure relevant new staff
involved in the prescribing, dispensing, or administration of ABECMA are trained and complete the Knowledge Assessment and submit it to
the REMS Program.
| Knowledge Assessment |
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 |
Verify that a minimum of two doses of tocilizumab are available onsite
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 ABECMA 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 ABECMA on the REMS Program requirements using
the Training Program.
| Training Program |
Have all relevant staff involved in prescribing, dispensing, or
administering ABECMA successfully complete the Knowledge
Assessment.
| Knowledge Assessment |
At all times
Report any serious adverse events suggestive of CRS or neurologic
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 Celgene Corporation or a third
party acting on behalf of Celgene Corporation to ensure that all
training, processes, and procedures are in place and are being
followed.
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
04/20/2021
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.