Fixed-dose combination
Nivolumab and Relatlimab is a fixed-dose combination of a lymphocyte activation gene-3 blocker and a programmed death receptor-1 blocking antibody indicated for the treatment of adult, among other approved uses. MedsAcross supplies Nivolumab and Relatlimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Source: US FDA prescribing information
Relatlimab is a human IgG4 monoclonal antibody that binds to the LAG-3 receptor, blocks interaction with its ligands, including MHC II, and reduces LAG-3 pathway-mediated inhibition of the immune response. Antagonism of this pathway promotes T cell proliferation and cytokine secretion. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human IgG4 monoclonal antibody that binds to the PD-1 receptor, blocks interaction with its ligands PD-L1 and PD-L2, and reduces PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Source: US FDA prescribing information
• Adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks. • Administer OPDUALAG as an intravenous infusion over 30 minutes. • See full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions for the injection.
Source: US FDA prescribing information
None. • None.
Source: US FDA prescribing information
• Immune-Mediated Adverse Reactions: o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis with renal dysfunction, and immune-mediated myocarditis. o Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue based on severity and type of reaction. • Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue OPDUALAG based on severity of reaction.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling. • Severe and Fatal IMARs • Infusion-Related Reactions • Complications of Allogeneic HSCT The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. The most common laboratory abnormalities (≥20%) are decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium.
Source: US FDA prescribing information
Store OPDUALAG refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Nivolumab and Relatlimab, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Opdualag 240 mg/80 mg per 20 mL injectionIntravenous Cold chain | Nivolumab and Relatlimab | ER Squibb & Sons | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Nivolumab and Relatlimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Nivolumab and Relatlimab, including Opdualag.
Yes. The US FDA first approved Nivolumab and Relatlimab on 18 March 2022, according to Drugs@FDA.
Yes. Nivolumab and Relatlimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Nivolumab and Relatlimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Nivolumab and Relatlimab is classified under ATC code L01FY02 (Nivolumab and Relatlimab).
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