Indications and Usage (1.2)     3/2015
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6)     3/2015

OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:

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unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. (1.1)
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. (1.1, 14.1)

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metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. (1.2)

Administer 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks. (2.1)

Injection: 40 mg/4 mL and 100 mg/10 mL solution in a single-use vial. (3)
CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

Immune-mediated adverse reactions: Administer corticosteroids based on the severity of the reaction. (5.1, 5.2, 5.3, 5.4, 5.6)

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Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. (5.1)

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Immune-mediated colitis: Withhold for moderate or severe and permanently discontinue for life-threatening colitis. (5.2)

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Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. (5.3)

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Immune-mediated nephritis and renal dysfunction: Monitor for changes in renal function. Withhold for moderate or severe and permanently discontinue for life-threatening serum creatinine elevation. (5.4)

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Immune-mediated hypothyroidism and hyperthyroidism: Monitor for changes in thyroid function. Initiate thyroid hormone replacement as needed. (5.5)

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Embryofetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.7, 8.1, 8.3)

Most common adverse reaction (≥20%) in patients with melanoma was rash. (6.1)

Most common adverse reactions (≥20%) in patients with advanced squamous non-small cell lung cancer were fatigue, dyspnea, musculoskeletal pain, decreased appetite, cough, nausea, and constipation. (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.

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Lactation: Discontinue breastfeeding. (8.2)