Opdivo (nivolumab)
Bristol Myers Squibb · PD-1 Immune Checkpoint Inhibitor
What is Opdivo? Opdivo (nivolumab) is a PD-1 immune checkpoint inhibitor by Bristol Myers Squibb approved for over 15 tumor types including melanoma, NSCLC, urothelial carcinoma, renal cell carcinoma, HNSCC, Hodgkin lymphoma, colorectal cancer (MSI-H), hepatocellular carcinoma, esophageal cancer, gastric cancer, and more.
About Opdivo
| Brand Name | Opdivo |
| Generic / INN | nivolumab |
| Drug Class | PD-1 Immune Checkpoint Inhibitor |
| Manufacturer | Bristol Myers Squibb |
| Administration | Intravenous (IV) infusion |
| FDA Approval | 2014 |
FDA-Approved Uses for Opdivo
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Unresectable or metastatic melanoma (with or without ipilimumab)
- Adjuvant melanoma after resection
- Non-small cell lung cancer (NSCLC) — multiple lines
- Malignant pleural mesothelioma (with ipilimumab)
- Renal cell carcinoma (RCC) — adjuvant and advanced settings
- Classical Hodgkin lymphoma (relapsed/refractory)
- Squamous cell carcinoma of the head and neck (SCCHN)
- Urothelial carcinoma
- MSI-H or dMMR colorectal cancer
- Hepatocellular carcinoma
- Esophageal/gastroesophageal junction cancer
- Gastric/GEJ adenocarcinoma
- Cervical cancer (with chemotherapy)
- Endometrial carcinoma (with cabozantinib)
How Does Opdivo Work?
Nivolumab blocks the PD-1 receptor on T cells, preventing tumor cells from using the PD-L1/PD-L2 ligands to suppress immune detection. By restoring T cell activity, nivolumab enables the immune system to recognize and attack cancer cells across multiple tumor types.
Dosage & Administration
Dosing varies by indication: 240 mg every 2 weeks, 480 mg every 4 weeks, or weight-based dosing (3 mg/kg). Often combined with ipilimumab (Yervoy). The treating oncologist determines the specific schedule based on the indication and combination therapy.
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
Warnings, Precautions & Side Effects
General Warning
Immune-mediated adverse reactions can affect any organ system — pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, myocarditis, encephalitis. Can be severe or fatal. Infusion-related reactions. Embryo-fetal toxicity. Complications of allogeneic HSCT.
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathies
- Immune-mediated myocarditis
- Infusion-related reactions
- Embryo-fetal toxicity
Common Side Effects
- Fatigue
- Musculoskeletal pain
- Rash
- Pruritus
- Diarrhea
- Nausea
- Decreased appetite
- Cough
- Dyspnea
- Constipation
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Opdivo is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Opdivo. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Opdivo
Opdivo (nivolumab) is a PD-1 checkpoint inhibitor by Bristol Myers Squibb approved for over 15 cancer types. It works by blocking the PD-1 pathway that tumors use to hide from the immune system.
Both are PD-1 inhibitors but from different manufacturers (BMS vs Merck). They have overlapping but distinct approved indications, different dosing schedules, and are often studied in different combination regimens. Clinical selection depends on tumor type, prior therapy, and biomarker status.
Biomarker requirements vary by indication. PD-L1 testing, MSI-H/dMMR, and TMB-H may be required or informative for certain indications. Your oncologist will order appropriate testing.
Opdivo is covered by Medicare Part B and commercial insurance for approved indications with prior authorization. BiologicHealthPlus handles the full PA process.
Yes — Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a subcutaneous formulation approved for the same indications as IV nivolumab where subcutaneous administration is appropriate.
Related Medications & Conditions
Related Medications
Keytruda (pembrolizumab) · Yervoy (ipilimumab) · Tecentriq (atezolizumab) · Bavencio (avelumab)
Related Conditions
Melanoma · NSCLC · Renal cell carcinoma · Hodgkin lymphoma · Urothelial carcinoma · Hepatocellular carcinoma