Cytokine Release Syndrome, Neurologic Toxicities, HLM/MAS and Prolonged Cytopenia

Cytokine Release Syndrome (CRS)

• Cytokine Release Syndrome (CRS), including fatal or lifethreatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or lifethreatening CRS with tocilizumab or tocilizumab and corticosteroids. 

Neurologic Toxicities

• 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)

• 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.