CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
About ABECMA REMS
A REMS is a drug safety program to manage known or potential risks associated with a drug and is required by the United States (US) Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. ABECMA is only available under a restricted program called ABECMA REMS because of the serious risks of CRS and neurologic toxicities.
The goals of ABECMA REMS are to mitigate the risks of CRS and neurologic toxicities by:
Ensuring that hospitals and their associated clinic(s) 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.
ABECMA REMS Requirements
All hospitals and their associated clinic(s) must be certified and enrolled in the ABECMA REMS to be able to dispense ABECMA.
All relevant staff involved in the prescribing, dispensing, or administering of ABECMA are trained on ABECMA REMS requirements, and must successfully complete the Knowledge Assessment and submit it to the REMS Program.
Hospital and Associated Clinic Enrollment Instructions
To become certified to dispense ABECMA, hospitals and their associated clinic(s) must designate an authorized representative (AR) to complete REMS requirements and enroll in ABECMA REMS. The AR must:
Complete the ABECMA REMS Training Program (live in-person, via webcast, or online), which includes review of:
- REMS Training Program
- REMS Adverse Reaction Management Guide
Successfully complete the Knowledge Assessment and submit it to the REMS Program.
Oversee implementation and compliance with ABECMA REMS requirements to:
Ensure that all relevant staff involved in prescribing, dispensing, or administering of ABECMA are trained on the REMS requirements using the Training Program, and successfully complete and submit the Knowledge Assessment, and records are maintained of staff training.
Put processes and procedures in place to ensure that staff involved in the prescribing, dispensing, or administering of ABECMA are retrained on ABECMA REMS if ABECMA has not been dispensed at least once annually from the date of certification in the ABECMA REMS.
Prior to infusing ABECMA, put processes and procedures in place to verify a minimum of 2 doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within 2 hours).
Prior to infusing ABECMA, provide patients with the Patient Wallet Card and instruct patients to remain within 2 hours of the certified healthcare facility for at least 4 weeks following ABECMA infusion.
Ensure that when the hospital and its associated clinic(s) designate an AR, the AR must complete the Training Program, successfully complete the Knowledge Assessment, and complete and submit a new Hospital Enrollment Form.
Submit a completed Hospital Enrollment Form.
ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.