Opdivo

Melanoma (adjuvant and unresectable/metastatic); Non-small cell lung cancer; Malignant pleural mesothelioma; Renal cell carcinoma; Classical Hodgkin lymphoma; Squamous cell carcinoma of the head and neck; Urothelial carcinoma; Microsatellite instability-high (MSI-H) or dMMR colorectal cancer; Hepatocellular carcinoma; Esophageal cancer; Gastric/GEJ/esophageal adenocarcinoma

Single agent: 240 mg IV every 2 weeks or 480 mg IV every 4 weeks.
In combination with ipilimumab: Varies by indication — typically nivolumab 3 mg/kg IV followed by ipilimumab 1 mg/kg IV on the same day every 3 weeks for 4 doses, then nivolumab 240 mg or 480 mg maintenance.
Infusion time: Over 30 minutes.

Injection: 10 mg/mL solution in 4 mL (40 mg), 10 mL (100 mg), and 24 mL (240 mg) single-dose vials

No absolute contraindications listed. Contraindicated in patients with a history of severe hypersensitivity reaction to nivolumab.

• Immune-Mediated Adverse Reactions: Including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, encephalitis, and other organ-specific toxicities.
• Infusion-Related Reactions: Discontinue for severe or life-threatening reactions.
• Complications of Allogeneic HSCT after PD-1 Blockade: Increased risk of transplant-related complications.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Fatigue (46%), rash (28%), musculoskeletal pain (27%), diarrhea (25%), pruritus (21%), nausea (20%), decreased appetite (16%), cough (14%)

Immune-mediated pneumonitis (3.6%), colitis (2.9%), hepatitis (1.8%), nephritis (1.2%), endocrinopathies (10% including thyroid disorders)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

No formal drug interaction studies conducted. Avoid systemic corticosteroids and immunosuppressants before starting nivolumab.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Nivolumab is a human IgG4 monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2 ligands, thereby releasing PD-1 pathway-mediated inhibition of the anti-tumor immune response.

Steady-state reached by 12 weeks. Terminal half-life: 26.7 days. Clearance: 9.5 mL/h. Volume of distribution at steady state: 8.0 L.

Clinical efficacy and safety data supporting the approval of Opdivo are available in the full prescribing information and from the clinical trials listed below.

• CheckMate 067 — Nivolumab + ipilimumab vs. nivolumab vs. ipilimumab in untreated advanced melanoma. Phase III, n=945.
  🔬 NCT01844505 ↗ 📄 Primary Publication ↗ 📄 Primary Publication ↗
• CheckMate 017 — Nivolumab vs. docetaxel in previously treated advanced squamous NSCLC. Phase III, n=272.
  🔬 NCT01642004 ↗ 📄 Primary Publication ↗
• CheckMate 057 — Nivolumab vs. docetaxel in previously treated advanced nonsquamous NSCLC. Phase III, n=582.
  🔬 NCT01673867 ↗ 📄 Primary Publication ↗
• CheckMate 025 — Nivolumab vs. everolimus in previously treated advanced RCC. Phase III, n=821.
  🔬 NCT01668784 ↗ 📄 Primary Publication ↗
• CheckMate 9ER — Nivolumab + cabozantinib vs. sunitinib in 1L advanced RCC. Phase III, n=651.
  🔬 NCT03141177 ↗ 📄 Primary Publication ↗

Opdivo has FDA-approved indications across the following cancer types covered on PipelineEvidence: