Nivolumab And Relatlimab-rmbw

1 INDICATIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling. • Severe and Fatal IMARs [see Warnings and Precautions (5.1) ] • Infusion-Related Reactions [see Warnings and Precautions (5.2) ] • Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. (6.1) The most common laboratory abnormalities (≥20%) are decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium. (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.

8.1 Pregnancy Risk Summary Based on findings in animals and mechanism of action, OPDUALAG can cause fetal harm when administered to a pregnant woman. Administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death ( see Data ). Human IgG4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. The effects of OPDUALAG are likely to be greater during the second and third trimesters of pregnancy.

5 WARNINGS AND PRECAUTIONS • Immune-Mediated Adverse Reactions : (5.1) o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis with renal dysfunction, and immune-mediated myocarditis. o Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue based on severity and type of reaction. 4 CONTRAINDICATIONS None. • None. (4)