Anti-PD-1 + anti-LAG-3 Pregnancy: Not recommended during pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical benefit outweighs the potential risk. Effective contraception for at least 5 months after the last dose. Based on mechanism of action and animal data it can cause foetal harm; both components are IgG4 and can cross the placenta. Excretion in human milk unknown - a risk to the breast-fed infant cannot be excluded in the first few days after birth.

Nivolumab with relatlimab (Specialist drug)

Brand names: Opdualag

This is a specialist intravenous fixed-dose combination of the PD-1 inhibitor nivolumab with the LAG-3 inhibitor relatlimab, used in oncology for advanced melanoma; in rheumatology it is relevant mainly through its immune-related toxicities.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Nivolumab 480 mg with relatlimab 160 mg (fixed combination)

Route: Intravenous infusion over 30 minutes. Intravenous use only - must NOT be given as an intravenous push or bolus injection

Frequency: Every 4 weeks

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and patients must be given the patient card. The recommended dose applies to adults and adolescents 12 years of age and older; it is established for adolescent patients weighing at least 30 kg. Continue as long as clinical benefit is observed or until treatment is no longer tolerated. Dose escalation or reduction is NOT recommended - manage toxicity by dosing delay or discontinuation per SPC Table 1 (immune-related pneumonitis, colitis, hepatitis, nephritis, endocrinopathies, skin reactions, myocarditis and myocarditis-myositis-myasthenia gravis overlap syndrome). Safety and efficacy in children below 12 years of age have not been established. May be used undiluted or diluted with sodium chloride 0.9% or glucose 5%.

Dose adjustments

Renal

No dose adjustment required in mild or moderate renal impairment. Data in severe renal impairment are too limited to draw conclusions.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients

Side effects

Fatigue (41%)
Musculoskeletal pain (32%)
Rash (29%)
Arthralgia (26%), diarrhoea (26%) and pruritus (26%)
Headache (20%), nausea (19%), hypothyroidism (16%)
Serious reactions include adrenal insufficiency, anaemia, colitis, myocarditis and pneumonia (each approximately 1.1-1.4%)

Clinical monograph

How it works

It pairs dual immune checkpoint blockade, with nivolumab blocking PD-1 and relatlimab blocking the LAG-3 inhibitory receptor on T cells, together enhancing antitumour T-cell responses more than PD-1 blockade alone.

Prescribing in practice

Dual checkpoint blockade increases the frequency and severity of immune-related adverse events affecting many organs, including colitis, hepatitis, pneumonitis, endocrinopathies, myocarditis and inflammatory arthritis, demanding early recognition and often corticosteroid or immunosuppressive treatment.
Both components are given together as one infusion, and the combination should be managed by clinicians experienced in immunotherapy toxicity.
Endocrine and other immune effects can be delayed, severe or permanent and may require specialist input including from rheumatology.

Monitoring

Monitor liver, thyroid and broader endocrine function and remain vigilant for gastrointestinal, respiratory, cardiac, skin or joint symptoms of immune toxicity.

Counselling the patient

Report new diarrhoea, breathlessness, chest pain, rash or joint pain without delay.
Be aware side effects may appear after treatment has finished.
Tell any clinician you are receiving combined immunotherapy.

Evidence & guidelines

The fixed-dose nivolumab with relatlimab combination is approved for advanced melanoma based on improved progression-free survival over nivolumab alone, with immune-related toxicity well documented.

Reference: NICE TA950; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways