OPDUALAG
Generic Name/API: nivolumab and relatlimab-rmbw
Manufacturer: Bristol-Myers Squibb
Dosage Forms & Strength & Pack Size:
Tablets: 120 mg, light red, almond-shaped, film-coated, and debossed with “R” on one side and “120” on the other side.
Storage:
Store OPDUALAG refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect
from light until time of use. Do not freeze or shake.
—————————WARNINGS AND PRECAUTIONS ————————–
• Immune-Mediated Adverse Reactions: (5.1)
○ 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.
○Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
○Withhold or permanently discontinue based on severity and type of reaction. (2.2)
• Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue OPDUALAG (nivolumab and relatlimab-rmbw) based on severity of reaction. (2.2, 5.2)
• Complications of allogeneic HSCT: Fatal and other serious complications can occur in patient who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1
blocking antibody. (5.3)
• Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3)
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