Nivolumab and relatlimab-rmbw
Nivolumab and relatlimab-rmbw (brand Opdualag) is an intravenous combination immunotherapy used to treat unresectable or metastatic melanoma in adults and in children 12 and older.
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The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Opdualag is an IV immunotherapy for melanoma that cannot be removed surgically or has spread, in adults and children 12 and older weighing at least 40 kg; its two antibodies release the PD-1 and LAG-3 brakes on immune T cells, and since about 2022 it has become a leading first option for advanced melanoma, with no generic. Many people tolerate it fairly well, mostly noticing tiredness, muscle and joint pain, rash, itching or diarrhea. The main risk is the immune system attacking healthy organs, including lungs, bowel, liver, hormone glands and heart, which can be severe or fatal and can start even after treatment ends, so report new symptoms quickly.
Clinical pearls
- Liver, kidney and thyroid blood tests are checked before and during treatment, so keep every lab draw scheduled before your infusions.
- Unusual tiredness, headaches, weight change or extra thirst can signal a hormone gland problem or diabetes, not just cancer fatigue.
- Use effective contraception and avoid breastfeeding during treatment and for at least 5 months after the last dose.
- Mention any past chest radiation or a planned donor stem cell transplant before starting, since both carry specific risks with this drug class.
Patient information guide A plain-language walkthrough of Nivolumab and relatlimab-rmbw, written from its FDA label.
What Nivolumab and relatlimab-rmbw is used for
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Nivolumab and relatlimab-rmbw, sold as Opdualag, has one supported use:
- Opdualag treats unresectable or metastatic melanoma in adults and children 12 years or older (weighing at least 40 kg).
How Nivolumab and relatlimab-rmbw works
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Nivolumab blocks PD-1 and relatlimab blocks LAG-3. Both are "brakes" on T cells, the immune cells that can attack tumors. Blocking them helps T cells become more active and better able to fight melanoma. In lab studies, using both together increased T-cell activation more than either alone.
Nivolumab and relatlimab-rmbw dosage
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Opdualag is a fixed-dose combination given through a vein by a healthcare professional. It is usually given as a 30-minute infusion every 4 weeks.
- Treatment continues until the disease progresses or side effects become unacceptable.
- Your team may delay or stop doses if immune side effects occur. The label does not recommend lowering the dose.
- If you miss an appointment, contact your care team to reschedule.
Dosing details from the FDA-approved label
From the Nivolumab and relatlimab-rmbw prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg
- 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs
- Administer as an intravenous infusion over 30 minutes
- No dose reduction recommended; withhold or permanently discontinue for adverse reactions per Table 1
- Pediatric patients 12 years of age or older who weigh less than 40 kg
- The recommended dosage has not been established
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • 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. (2) • Administer OPDUALAG as an intravenous infusion over 30 minutes. (2) • See full Prescribing Information for dosage modifications for adverse reactions (2.2) and preparation and administration instructions for the injection (2.3) . 2.1 Recommended Dosage The recommended dosage of OPDUALAG for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs. The recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see Use in Specific Populations (8.4) ] . 2.2 Dosage Modifications No dose reduction for OPDUALAG is recommended. In general, withhold OPDUALAG for severe (Grade 3) immune-mediated adverse reactions (IMARs). Permanently discontinue OPDUALAG for life-threatening (Grade 4) IMARs, recurrent severe (Grade 3) IMARs that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids. Dosage modifications for adverse reactions that require management different from these general guidelines are summarized in Table 1. Table 1: Recommended Dosage Modifications for Adverse Reactions * Based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. a Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids. b Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Nivolumab and relatlimab-rmbw side effects
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In the main trial, the most common side effects were:
Common side effects
- Muscle and joint pain
- Tiredness (fatigue)
- Rash
- Itching
- Diarrhea
- Underactive thyroid (hypothyroidism)
- Headache
- Nausea
When to get medical help
- Call your doctor right away for new or worsening cough, shortness of breath or chest pain, which could signal lung inflammation (pneumonitis) or heart inflammation (myocarditis).
- Get help for diarrhea, bloody or dark stools, or belly pain, which could signal colitis (bowel inflammation).
- Report yellowing of the skin or eyes, dark urine, or nausea and vomiting, which can signal liver inflammation (hepatitis).
- Tell your care team about headaches, vision changes, extreme tiredness, or changes in weight, mood or thirst, which can signal hormone gland problems (thyroid, adrenal, pituitary) or diabetes.
- Report a severe or blistering rash, or one with skin peeling or mouth sores.
- Report decreased urination or swelling, which can signal kidney inflammation (nephritis).
- Tell the staff right away about fever, chills, or feeling unwell during the infusion, which can be an infusion reaction.
- Immune side effects can happen at any time, even after treatment ends, so report new symptoms promptly.
Blood tests commonly showed lower hemoglobin, lymphocytes and sodium, and higher liver enzymes (AST and ALT). Serious reactions affected about 36% of patients and included adrenal problems, colitis, pneumonitis and myocarditis. Report new symptoms to your care team promptly.
Nivolumab and relatlimab-rmbw warnings and precautions
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- Immune-mediated reactions can be severe or fatal and can affect the lungs, bowel, liver, hormone glands, kidneys, skin and heart. They can occur after treatment ends.
- Monitoring: liver enzymes, creatinine and thyroid function are checked at the start and periodically.
- Infusion reactions may require slowing, interrupting or stopping the infusion.
- Stem cell transplant: fatal and serious complications can occur if you receive an allogeneic transplant before or after this type of medicine.
- Pregnancy: it can cause fetal harm.
Before taking Nivolumab and relatlimab-rmbw
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- Pregnancy: it can harm an unborn baby. A pregnancy test is checked first, and effective contraception is advised during treatment and for at least 5 months after.
- Breastfeeding: not advised during treatment and for at least 5 months after the last dose.
- Children: studied in those 12 or older weighing at least 40 kg. Not established for smaller or younger children.
- Older adults: no overall differences in safety or effectiveness were seen.
- Transplant history: tell your doctor if you have had or may have an allogeneic stem cell transplant.
- Kidney or liver problems: mild to moderate problems did not change how the body clears the drug. Effects of severe problems are unknown.
What Nivolumab and relatlimab-rmbw does in the body
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How the drug's levels relate to its safety and effectiveness, and the timing of its effects on the body, have not been fully characterized.
How your body processes Nivolumab and relatlimab-rmbw
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Opdualag is given by IV, so it goes straight into the bloodstream. Steady levels build up by about 16 weeks with dosing every 4 weeks. The half-life is about 26 days for each component, so the drug stays in the body for weeks. Age, sex, race, and mild to moderate kidney or liver problems did not meaningfully change how it is cleared. Effects of severe kidney or liver problems are unknown.
How to store Nivolumab and relatlimab-rmbw
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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.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Nivolumab and relatlimab-rmbw: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Nivolumab and relatlimab-rmbw — the kind of thing our pharmacy team would talk through with you at the counter.
What is Opdualag for?
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How will I get it?
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What side effects are most common?
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What should I call my doctor about right away?
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Is it safe during pregnancy or breastfeeding?
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Is Nivolumab and relatlimab-rmbw available over the counter?
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When was Nivolumab and relatlimab-rmbw first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Nivolumab and relatlimab-rmbw on HelloPharmacist
Nivolumab and relatlimab-rmbw forms and strengths (how it comes)
Nivolumab and relatlimab-rmbw is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Nivolumab and relatlimab-rmbw inactive ingredients by manufacturer.
Injection
How this form is used
- Opdualag is used for unresectable or metastatic melanoma in adults and children 12 or older who weigh at least 40 kg.
- Opdualag is given as an intravenous infusion over about 30 minutes.
- Opdualag is given every 4 weeks until the disease gets worse or side effects become unacceptable.
- Opdualag should not be given through the same IV line as other drugs.
Nivolumab and relatlimab-rmbw on the U.S. market: products, makers and brands
How Nivolumab and relatlimab-rmbw appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Nivolumab and relatlimab-rmbw product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2022. Brand names on the directory include Opdualag; the rest are generics.
How widely Nivolumab and relatlimab-rmbw is used (Medicaid data)
A general measure of how commonly Nivolumab and relatlimab-rmbw is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q2 2025 – Q1 2026, summed across every form and brand of the drug.
Think of this as a proxy for how widely Nivolumab and relatlimab-rmbw is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Nivolumab and relatlimab-rmbw prescribed? Of the 1,601 medications we measure, Nivolumab and relatlimab-rmbw ranks #1,460 by Medicaid prescriptions — more than 9% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Nivolumab and relatlimab-rmbw, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Nivolumab and relatlimab-rmbw NDCs with Medicaid activity.
Compare Nivolumab and relatlimab-rmbw products
A representative set of FDA-listed product records for Nivolumab and relatlimab-rmbw — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| NIVOLUMAB 12 mg/mL; RELATLIMAB 4 mg/mL | Intravenous | E.R. Squibb & Sons, L.L.C. | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Nivolumab and relatlimab-rmbw NDCs →
Nivolumab and relatlimab-rmbw side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Nivolumab and relatlimab-rmbw — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Nivolumab and relatlimab-rmbw in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Nivolumab and relatlimab-rmbw FDA approval history
How Nivolumab and relatlimab-rmbw went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Nivolumab and relatlimab-rmbw recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Nivolumab and relatlimab-rmbw recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 Lots: Lot: 033A23B, Expiry: 4/30/2026 FDA record D-0097-2026 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Nivolumab and relatlimab-rmbw supply and shortage status
Whether Nivolumab and relatlimab-rmbw is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Nivolumab and relatlimab-rmbw brand names
Nivolumab and relatlimab-rmbw is sold under one brand name in the FDA directory — Opdualag. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Nivolumab and relatlimab-rmbw: manufacturers and labelers
One company lists Nivolumab and relatlimab-rmbw products with the FDA. By number of product records, the largest are E.R. Squibb & Sons, L.L.C.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sources for this Nivolumab and relatlimab-rmbw page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. E.R. Squibb & Sons, L.L.C. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →