Idecabtagene Vicleucel

1 INDICATIONS AND USAGE ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 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 two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ( 1 )

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Early Death [see Warnings and Precautions (5.1) , Clinical Studies (14) ] • Cytokine Release Syndrome [see Warnings and Precautions (5.2) ] • Neurologic Toxicities [see Warnings and Precautions (5.3) ] • Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) [see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] • Infections [see Warnings and Precautions (5.6) ] • Prolonged Cytopenias [see Warnings and Precautions (5.7) ] • Hypogammaglobulinemia [see Warnings and Precautions (5.8) ] The most common nonlaboratory adverse reactions (incidence ≥20%) include pyrexia, CRS, hypogammaglobulinemia, infections–pathogen unspecified, m...

8.1 Pregnancy Risk Summary There are no available data with ABECMA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ABECMA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if ABECMA has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia.

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • 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. 5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Monitor for hypersensitivity reactions during infusion. ( 5.5 ) • Infections : Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.6 ) • Prolonged Cytopenias : Patients may exhibit prolonged Grade 3 or higher cytopenias following ABECMA infusion. Monitor blood counts prior to and after ABECMA infusion. ( 5.7 ) • Hypogammaglobulinemia : Monitor and consider immunoglobulin replacement therapy. ( 5.8 ) • Secondary Malignancies : T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. 4 CONTRAINDICATIONS None. None. ( 4 )