Opdyta Injection

Nivolumab™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Nivolumab 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.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Immune-Mediated Adverse Reactions: 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. - Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue Nivolumab based on severity of reaction. - 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. - Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. Severe and Fatal Immune-Mediated Adverse Reactions Nivolumab potentially breaks peripheral tolerance and induces immune-mediated adverse reactions (IMARs). Important IMARs listed under Warnings and Precautions may not include all possible severe and fatal IMARs. IMARs, which may be severe or fatal, can occur in any organ system or tissue. IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies. While IMARs usually manifest during treatment, IMARs can also manifest after discontinuation. Early identification and management of IMARs are essential to ensure safe use. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs. In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue Nivolumab depending on severity. In general, if Nivolumab requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling. - Severe and Fatal IMARs - Infusion-Related Reactions - Complications of Allogeneic HSCT The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. The most common laboratory abnormalities (≥20%) are decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium. 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 practice. The safety of Nivolumab was evaluated in RELATIVITY-047, a randomized (1:1), double-blinded trial in 714 patients with previously untreated metastatic or unresectable melanoma. Patients received intravenous Nivolumab (nivolumab 480 mg and relatlimab 160 mg) every 4 weeks (n=355) or nivolumab 480 mg by intravenous infusion every 4 weeks (n=359). Patients were treated with Nivolumab until disease progression or unacceptable toxicity. The median duration of exposure was 6 months (range: 0 to 31 months) in Nivolumab-treated patients and 5 months (range: 0 to 32 months) in nivolumab-treated patients. Serious adverse reactions occurred in 36% of patients treated with Nivolumab. The most frequent serious adverse reactions reported in ≥1% of patients treated with Nivolumab were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%). Fatal adverse reaction occurred in 3 (0.8%) patients who were treated with Nivolumab; these included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis. Nivolumab was permanently discontinued due to adverse reactions in 18% of patients. Adverse reactions which resulted in permanent discontinuation of Nivolumab in ≥1% of patients included myocarditis (1.7%) and pneumonitis (1.4%). Dosage interruptions due to an adverse reaction occurred in 43% of patients who received Nivolumab. Adverse reactions that required dosage interruption in ≥2% of patients who received Nivolumab were diarrhea (3.9%), troponin increased (3.9%), AST increased (2.8%), troponin T increased (2.8%), ALT increased (2.3%), arthralgia (2.3%), hypothyroidism (2.3%), anemia (2%), fatigue (2%), pneumonitis (2%), and rash (2%). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.