Prescription medicine
Nivolumab and relatlimab Brand names: Opdualag
Nivolumab and relatlimab (Opdualag) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nivolumab and relatlimab FDA label on DailyMed (effective June 8, 2026); every nivolumab and relatlimab label on DailyMed.
Highlights of the record
FDA label of June 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Forms and strengths
- 12 mg/ml / 4 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest October 21, 2025
- FAERS reports
- 472 through July 30, 2026
What is nivolumab and relatlimab used for?
From the label: indications and usageOPDUALAG™ 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.
FDA pharmacologic class: Lymphocyte Activation Gene-3 Blocker and Programmed Death Receptor-1 Blocking Antibody.
Source: FDA drug label (OPDUALAG), E.R. Squibb & Sons, L.L.C., effective June 8, 2026 (SPL set b22c9d83-3256-4e17-85f7-f331a504adc6), via openFDA; the full label on DailyMed
What does the patient leaflet for nivolumab and relatlimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OPDUALAG?OPDUALAG is a medicine that may treat a type of skin cancer called melanoma by working with your immune system. OPDUALAG can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Call or see your healthcare provider right away if you develop any new or worse signs of symptoms, including: Lung problems. • new or worsening cough • shortness of breath • chest pain Intestinal problems. • diarrhea (loose stools) or more frequent bowel movements than usual • stool that are black, tarry, sticky, or have blood or mucus • severe stomach-area (abdominal) pain or tenderness Liver problems. […] These are not all of the signs and symptoms of immune system problems that can happen with OPDUALAG. Call or see your healthcare provider right away for any new or worsening sign or symptoms, which may include: • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight • Persistent or severe muscle pain or weakness, muscle cramps • Low red blood cells, bruising Getting medical treatment right away may keep these problems from becoming more serious. […]
Source: FDA drug label (OPDUALAG), E.R. Squibb & Sons, L.L.C., effective June 8, 2026 (SPL set b22c9d83-3256-4e17-85f7-f331a504adc6), via openFDA; the full label on DailyMed
Is there a generic for nivolumab and relatlimab (Opdualag)?
No generic nivolumab and relatlimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has nivolumab and relatlimab been recalled?
The FDA's Enforcement Report lists 1 recall naming nivolumab and relatlimab since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 21, 2025 | Class II | Bristol-Myers Squibb Company | Lack of Assurance of Sterility. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nivolumab and relatlimab label say about other medicines?
The nivolumab and relatlimab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methylprednisolone | warnings and precautions | If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup. |
| Prednisone | warnings and precautions | In general, if OPDUALAG requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Source: FDA drug label (OPDUALAG), E.R. Squibb & Sons, L.L.C., effective June 8, 2026 (SPL set b22c9d83-3256-4e17-85f7-f331a504adc6), via openFDA; the full label on DailyMed
What do FAERS reports show for nivolumab and relatlimab?
The FDA Adverse Event Reporting System holds 472 reports that list nivolumab and relatlimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 95 are coded as a death and 103 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other programmed death receptor-1 blocking antibodys
- the pharmacologic class, with prices and generics
- Nivolumab and relatlimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other