Opdivo (Nivolumab)

What it is and what it treats

Nivolumab is a fully human monoclonal antibody that blocks the PD-1 receptor on T-lymphocytes, preventing its interaction with PD-L1 and PD-L2 ligands expressed by tumour and other cells. By interrupting this inhibitory signal, nivolumab restores the capacity of T-cells to recognise and attack malignant cells. It belongs to the same therapeutic class as pembrolizumab (Keytruda) and is administered intravenously under oncology specialist supervision.

Regulatory approvals for nivolumab, granted by authorities including the FDA and EMA, span multiple tumour types such as melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer with specific biomarker status, hepatocellular carcinoma, oesophageal cancer and malignant pleural mesothelioma. Approved indications, whether given alone or with ipilimumab, and reimbursement status vary between countries.

As with other checkpoint inhibitors, treatment decisions involving nivolumab are made by the treating oncology team with reference to the applicable national product label, tumour biomarker findings and clinical guidelines. It is not intended for patient self-selection or administration outside a supervised oncology setting.

Presentations and dosage forms

• 40 mg/4 mL (10 mg/mL) concentrate for solution for infusion (single-use vial)
• 100 mg/10 mL (10 mg/mL) concentrate for solution for infusion (single-use vial)
• 240 mg/24 mL (10 mg/mL) concentrate for solution for infusion (single-use vial)
• Clear to opalescent, colourless to pale-yellow solution
• Supplied for single use only; no preservative

How it is administered

The approved EU SmPC and FDA prescribing information describe nivolumab monotherapy as an intravenous infusion given over approximately 30 to 60 minutes, typically at a fixed dose of 240 mg every 2 weeks or 480 mg every 4 weeks, continued until disease progression, unacceptable toxicity, or completion of the approved treatment duration for the indication concerned.

In several indications — including certain melanoma, renal cell carcinoma, hepatocellular carcinoma and mesothelioma settings — nivolumab is described in the product label as being given in combination with ipilimumab, using weight-based or fixed induction dosing for a defined number of cycles, followed by nivolumab maintenance monotherapy. Combination dosing schedules and the sequence of infusion (nivolumab followed by ipilimumab after an observation interval) are specified in the applicable label and should be confirmed directly with the current prescribing information.

The labelled information describes dose interruption and permanent discontinuation criteria for immune-related adverse reactions graded by severity. This content is descriptive of the approved label and is not a treatment recommendation; dose modification decisions rest with the treating clinician.

Storage and handling

• Store refrigerated at 2°C to 8°C in the original carton to protect from light
• Do not freeze
• Do not shake the vial
• Diluted solution may be stored per the product information for a limited period under refrigeration or at room temperature prior to administration
• Dispose of unused product and materials in accordance with local requirements for biological medicinal products

Side effects

The following reflects adverse reaction information described in the approved EU SmPC and FDA prescribing information for nivolumab. Reaction rates and severity are higher when nivolumab is combined with ipilimumab compared with nivolumab monotherapy, reflecting the additive effect of dual checkpoint blockade.

Commonly reported

Serious effects requiring medical attention

Any new or worsening symptom should be reported promptly to the treating oncology team, since early identification of immune-related reactions is central to safe management. Suspected adverse reactions should also be reported through the applicable national pharmacovigilance scheme (e.g. Yellow Card in the UK, MedWatch in the US).

Opdivo (nivolumab) vs Keytruda (pembrolizumab)

Opdivo and Keytruda are both PD-1 checkpoint inhibitors with a shared general mechanism of action, and both were first approved in 2014. The principal differences lie in their approved indications, dosing intervals and, notably, their common combination partners: Opdivo is frequently used together with ipilimumab (Yervoy), a CTLA-4 inhibitor, for dual checkpoint blockade, whereas Keytruda is more often combined with chemotherapy or targeted agents such as lenvatinib.

The nivolumab plus ipilimumab combination is described in regulatory labelling for melanoma, renal cell carcinoma, hepatocellular carcinoma, colorectal cancer with specific biomarker status, and mesothelioma. Clinical trial data referenced in the product information indicate a materially higher rate of severe (Grade 3–4) immune-related adverse events with the combination than with nivolumab monotherapy, which is a key factor the treating oncologist weighs against the potential efficacy benefit for the specific tumour type.

Because both agents act on the same PD-1 pathway, switching from one to the other after treatment failure is not generally expected to change the mechanism of resistance. Selection between nivolumab and pembrolizumab, or a move to a different therapeutic strategy altogether, is a matter for the treating multidisciplinary oncology team, guided by the approved label, biomarker findings and prior treatment history.

Availability and supply route

Registration and reimbursement status for nivolumab vary by country and depend on national health authority approval, local labelling and the specific indication, including whether it is approved as monotherapy or in combination with ipilimumab. Clinicians and procurement teams should verify current registration status and the approved label with the relevant national regulator before sourcing or initiating treatment.

In settings where a product is not yet locally registered for a given indication, some healthcare systems operate named-patient or compassionate supply frameworks permitting access on an individual physician's request, subject to national import and pharmacovigilance controls. This is distinct from routine retail supply and requires a valid prescription and complete documentation throughout the supply chain.

Pharmacy Remedy is a licensed Turkish pharmaceutical wholesaler operating in the B2B channel; it supplies hospitals, clinics and other licensed healthcare entities against valid prescriptions and appropriate import documentation, and does not sell medicines to members of the public. All supply of nivolumab is subject to verification of licensure, prescription validity and compliance with the destination country's import and pharmacovigilance requirements.

Frequently asked questions

Primary sources

• EMA — Opdivo (nivolumab) product information
• FDA — Opdivo (nivolumab) prescribing information

Further reading and regulatory routes

• Which country Opdivo is sourced from, and why prices differ
• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Keytruda (pembrolizumab)
• Herceptin (trastuzumab)
• Kyprolis (carfilzomib)