Opdivo (nivolumab) supply for hospitals & distributors

Product facts

Strengths and presentation

• 40 mg/4 mL (10 mg/mL) concentrate for solution for infusion
• 100 mg/10 mL (10 mg/mL) concentrate for solution for infusion
• 120 mg/12 mL and 240 mg/24 mL vials (market-dependent)

Approved indications (EMA / FDA label summary)

• Melanoma (advanced and adjuvant)
• Non-small cell lung cancer, including neoadjuvant use with chemotherapy
• Renal cell carcinoma
• Classical Hodgkin lymphoma
• Head and neck, urothelial, oesophageal and gastric cancer
• MSI-H / dMMR colorectal cancer and malignant pleural mesothelioma (with ipilimumab)

Short label summary only. Approved indications differ by country and line of therapy; the national label in the destination country governs.

Storage and cold chain

• Store refrigerated at 2–8 °C in the original carton to protect from light
• Do not freeze; do not shake
• Shipped in validated cold-chain packaging with temperature data logging

How we supply

• Original manufacturer packs only — sourced from licensed wholesalers in Türkiye and Europe, never repackaged or relabelled.
• Batch number and expiry confirmed in writing before dispatch; every pack is traceable to its batch.
• Documents with every consignment: commercial invoice, batch / CoA information from the source, and packing list.
• Validated 2–8 °C cold-chain shipping with a temperature data logger from origin to handover.
• Named-patient and special-import support: we prepare the paperwork your hospital or importer needs for the local regulator.

Procurement notes

Because Opdivo is dosed as a flat dose (for example 240 mg every 2 weeks or 480 mg every 4 weeks), procurement teams usually combine 40 mg and 100 mg vials to reduce wastage. Tell us the regimen and we will propose the vial mix available for the current batch.

Who we supply

• Hospital pharmacy and procurement departments
• Licensed pharmaceutical distributors and importers
• Oncology and haematology centres
• Treating physicians arranging named-patient supply

Markets served

United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Oman, Bahrain and Iraq. Import into each country follows that country's regulator (for example MOHAP / DoH / DHA, SFDA, MoPH, Kuwait MOH, Oman MOH, NHRA) — we work with the receiving institution's import route.

Clinical reference

Administration (per label)

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.

Serious adverse reactions listed in the label

• Immune-mediated pneumonitis
• Immune-mediated colitis
• Immune-mediated hepatitis
• Immune-mediated endocrinopathies (thyroid disorders, adrenal insufficiency, hypophysitis, type 1 diabetes)
• Immune-mediated nephritis
• Severe skin reactions
• Infusion-related reactions
• Substantially increased frequency and severity of the above when combined with ipilimumab

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.

Frequently asked questions

Other medicines we supply to the Gulf

• Keytruda (pembrolizumab)
• Enhertu (trastuzumab deruxtecan)
• Tagrisso (osimertinib)
• Darzalex (daratumumab)
• Imfinzi (durvalumab)
• Tecentriq (atezolizumab)
• Perjeta (pertuzumab)
• Kadcyla (trastuzumab emtansine)
• Lynparza (olaparib)
• Revlimid (lenalidomide)
• Imbruvica (ibrutinib)
• Venclyxto (venetoclax)
• Xtandi (enzalutamide)
• Adcetris (brentuximab vedotin)

Sources

• EMA — Opdivo EPAR / SmPC