Abecma Side Effects

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, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections.

( 6.1 ) The most common Grade 3 or 4 laboratory adverse reactions (incidence ≥50%) include leukocyte count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, and hemoglobin decreased.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety data described in the WARNINGS and PRECAUTIONS section reflect exposure to ABECMA in 349 patients with relapsed or refractory multiple myeloma: one randomized, open-label study with 222 patients in Study 1 and one single-arm, open-label study with 127 patients in Study

Study 1 The safety data described in this section reflect the exposure to ABECMA in Study 1, in which 222 patients with relapsed or refractory multiple myeloma received ABECMA across a dose range of 175 to 529 × 10 6 CAR-positive T cells (median dose: 445 × 10 6 CAR-positive T cells) [see Clinical Studies (14) ] .

Patients with a history of CNS disease or requiring ongoing treatment with chronic immunosuppression were excluded.

The median age of the safety population was 63 years (range: 30 to 81 years);

43% were 65 years or older, and 63% were men.

The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 in 47%, 1 in 51%, 2 in 1.4% and 3 in 0.5% of patients.