Nivolumab and relatlimab-rmbw
Nivolumab and relatlimab-rmbw is a dual immune checkpoint-blocking combination used to treat unresectable or metastatic melanoma in adults and adolescents 12 years and older.
🧬 Where this information comes from Click to expand
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 →
📖 Nivolumab and relatlimab-rmbw: Patient Information Guide
A plain-language walkthrough of Nivolumab and relatlimab-rmbw — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Nivolumab and relatlimab-rmbw is a combination immunotherapy approved for the following use:
- Opdualag (intravenous injection) is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years of age or older who weigh at least 40 kg. "Unresectable" means the tumor cannot be removed with surgery; "metastatic" means it has spread beyond the original site.
- A recommended dose has not been established for patients younger than 12, or for those 12 and older who weigh less than 40 kg.
⚙️How it works▾
Opdualag contains two antibodies that each block a different checkpoint — a signal that normally prevents the immune system from going too far. Nivolumab blocks PD-1, a receptor on T cells (immune cells) that tumors exploit to hide from immune attack. Relatlimab blocks LAG-3, another receptor that also dampens T cell activity. By disabling both checkpoints at the same time, Opdualag produces stronger T cell activation and a more powerful anti-tumor response than either agent alone. In laboratory tumor models, this dual blockade both slowed tumor growth and caused tumor shrinkage.
💊How it's taken▾
Opdualag is given as a 30-minute intravenous (IV) infusion at an infusion center or hospital — it is not taken at home by mouth. It is administered once every 4 weeks and continued until the cancer progresses or side effects become intolerable. No dose reductions are recommended; instead, the infusion may be paused or permanently stopped based on how side effects are managed.
- Do not miss scheduled infusions without speaking to your care team first.
- If you have a reaction during the infusion, your nurse may slow or stop it temporarily.
- Always follow your prescriber's specific instructions and the infusion center's guidance.
🤒Side effects — in detail▾
The most common side effects reported with Opdualag include:
- Musculoskeletal pain (muscle and joint aches) — the most common, occurring in nearly half of patients
- Fatigue
- Rash
- Itching (pruritus)
- Diarrhea
- Nausea
- Headache
- Hypothyroidism (underactive thyroid)
- Decreased appetite
- Cough
Serious immune-related reactions — affecting the lungs, liver, colon, kidneys, skin, heart, or hormone glands — can also occur and may be life-threatening. Contact your care team immediately if you notice any new or worsening symptoms between infusions.
⚠️Warnings & precautions▾
- Immune-mediated adverse reactions: Opdualag can trigger inflammation in virtually any organ. Key ones include pneumonitis (lung inflammation), colitis (gut inflammation), hepatitis (liver inflammation), nephritis (kidney inflammation), myocarditis (heart inflammation), and endocrine (hormone gland) problems including adrenal insufficiency, thyroid disorders, and hypophysitis. These can occur during treatment or after it ends and may require corticosteroids or permanent discontinuation of Opdualag.
- Infusion-related reactions: Reactions can occur during or after the IV infusion. Your care team is prepared to slow or stop the infusion and provide supportive care.
- Allogeneic stem cell transplant (HSCT) complications: Patients who receive a bone marrow transplant before or after treatment with a PD-1–blocking medicine like Opdualag face an increased risk of serious, potentially fatal complications.
- Fetal harm: Opdualag can damage a developing baby. Pregnancy should be ruled out before starting treatment, and effective contraception is required during treatment and for at least 5 months after the last dose.
🔀What it interacts with▾
The Opdualag label does not list specific drug, food, or supplement interactions. However, because Opdualag is an immune-activating therapy, tell your care team about all medications you take — especially:
- Corticosteroids or other immunosuppressants — these may reduce Opdualag's effectiveness if used before treatment, though they are used to manage side effects once treatment has started.
- All prescription and over-the-counter medications and supplements — your oncology team needs a complete list to anticipate any potential concerns.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Opdualag can cause fetal harm. Tell your doctor if you are pregnant or could become pregnant. Effective contraception is required during treatment and for at least 5 months after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for at least 5 months after the last dose, as the medication may pass into breast milk and harm a nursing infant.
- Autoimmune conditions: Because Opdualag activates the immune system, people with pre-existing autoimmune diseases need careful discussion with their doctor before starting treatment.
- Bone marrow or stem cell transplant: Patients who have had or plan to have an allogeneic HSCT face higher risks of serious complications.
- Liver or kidney impairment: Mild-to-moderate impairment does not significantly change how the drug is processed, but the effects of severe liver or kidney disease are not known.
- Pediatric patients: Opdualag is approved for patients 12 years and older who weigh at least 40 kg. It has not been established as safe or effective for younger children or those under the weight threshold.
- Older adults: Patients 65 and older were well represented in clinical trials and showed no overall difference in safety or effectiveness compared to younger adults.
📡Pharmacodynamics — effects in the body▾
The precise relationship between Opdualag's blood levels and its effects on safety or tumor response has not been fully characterized. The drug works by activating T cells of the immune system, but the full time course of this immune activation and its connection to clinical outcomes is still being studied.
🔬Pharmacokinetics — how your body processes it▾
Both nivolumab and relatlimab are antibodies given intravenously and distribute primarily within the bloodstream and tissues, each with a volume of distribution of about 6.6 liters. After an every-4-week dosing schedule, steady-state blood levels of relatlimab are reached by about 16 weeks. The effective half-life — how long it takes the body to clear half of the drug — is approximately 26 days for both nivolumab and relatlimab, meaning these medicines stay in the body for weeks after each dose. Age, sex, race, and mild-to-moderate kidney or liver impairment do not meaningfully change how the body processes either drug; however, the effects of severe kidney or liver disease are not known.
📦How to store it▾
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 Nivolumab and relatlimab-rmbw’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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 exactly is Opdualag and why did my doctor prescribe it for melanoma? ▾
How is this medication given, and how often will I need to go to the infusion center? ▾
What side effects should I expect, and which ones mean I need to call someone right away? ▾
Can I get pregnant or breastfeed while I'm on this treatment? ▾
Will this medication affect my thyroid or other hormone levels? ▾
Are there any other medicines or supplements I should tell my doctor about before starting? ▾
Is Nivolumab and relatlimab-rmbw available over the counter? ▾
When was Nivolumab and relatlimab-rmbw first available? ▾
💬 Answers drafted from Nivolumab and relatlimab-rmbw’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Nivolumab and relatlimab-rmbw 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.
Injection
How this form is used
- Opdualag intravenous injection is used to treat unresectable or metastatic melanoma in adults and in patients 12 years and older who weigh at least 40 kg.
- Opdualag is administered as an intravenous infusion over 30 minutes, once every 4 weeks.
- Opdualag can be given undiluted or diluted with sodium chloride or dextrose solution; it should not be mixed with other drugs in the same IV line.
- Opdualag should be visually inspected before use — discard the vial if the solution appears cloudy, discolored, or contains unusual particles.
- Once prepared, Opdualag solution should be used within 8 hours at room temperature or within 24 hours if refrigerated; it should not be frozen.
📊 Nivolumab and relatlimab-rmbw across the U.S. market
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.
📈 How widely Nivolumab and relatlimab-rmbw is used
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 Q1–Q4 2025, 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 1,594 medications we measure, Nivolumab and relatlimab-rmbw ranks #1,438 by Medicaid prescriptions — more than 10% 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 → |
| 12; 4 mg/mL; mg/mL | Intravenous | E.R. Squibb & Sons, L.L.C. | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Nivolumab and relatlimab-rmbw NDCs →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Nivolumab and relatlimab-rmbw went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & 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.
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🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. E.R. Squibb & Sons, L.L.C. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.