Nivolumab Injection
Nivolumab injection (Opdivo) is an immunotherapy used to treat a wide range of cancers, including melanoma, lung cancer, kidney cancer, bladder cancer, colorectal cancer, liver cancer, esophageal cancer, and several others.
🧬 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 Injection: Patient Information Guide
A plain-language walkthrough of Nivolumab Injection — 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▾
Opdivo (nivolumab) injection is an immunotherapy approved to treat a broad range of cancers in adults, and some in patients aged 12 and older. Here is the full list of supported uses:
- Melanoma: Opdivo treats unresectable or metastatic melanoma (alone or with ipilimumab) in adults and patients 12+; also used as adjuvant therapy after surgical removal of Stage IIB–IV melanoma
- Non-Small Cell Lung Cancer (NSCLC): Opdivo is used before surgery (neoadjuvant) with chemotherapy for resectable NSCLC; also as first-line therapy with ipilimumab (with or without chemotherapy) for metastatic NSCLC; and for metastatic NSCLC after platinum-based chemotherapy fails
- Malignant Pleural Mesothelioma: Opdivo combined with ipilimumab is a first-line treatment for unresectable disease in adults
- Renal Cell Carcinoma (kidney cancer): Opdivo with ipilimumab for intermediate/poor-risk advanced disease; with cabozantinib as first-line advanced therapy; or alone after prior anti-angiogenic therapy
- Classical Hodgkin Lymphoma: Opdivo with doxorubicin, vinblastine, and dacarbazine (AVD) for previously untreated Stage III–IV disease in adults and patients 12+; alone for relapsed or refractory disease in adults
- Squamous Cell Carcinoma of the Head and Neck: Opdivo treats recurrent or metastatic disease after platinum-based therapy fails in adults
- Urothelial Carcinoma (bladder cancer): Opdivo is used as adjuvant therapy after radical resection in high-risk adults; as first-line therapy with cisplatin and gemcitabine for unresectable or metastatic disease; and for locally advanced or metastatic disease after platinum-based chemotherapy
- Colorectal Cancer (MSI-H or dMMR): Opdivo with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer in adults and patients 12+; Opdivo alone for metastatic disease that has progressed after fluoropyrimidine, oxaliplatin, and irinotecan
- Hepatocellular Carcinoma (liver cancer): Opdivo with ipilimumab as first-line treatment for unresectable or metastatic HCC; also for patients previously treated with sorafenib
- Esophageal Cancer: Opdivo as adjuvant therapy after resection and neoadjuvant chemoradiotherapy; as first-line therapy for esophageal squamous cell carcinoma (ESCC) with PD-L1 ≥1 (with chemotherapy or ipilimumab); and for previously treated ESCC in adults
- Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma: Opdivo with fluoropyrimidine- and platinum-containing chemotherapy for PD-L1 ≥1 tumors in adults
⚙️How it works▾
Cancer cells can exploit a checkpoint protein called PD-1, found on T cells (immune cells that fight disease). By binding to PD-1 and activating it, tumors essentially tell the immune system to stand down. Opdivo is a monoclonal antibody that blocks PD-1, preventing this suppression and allowing T cells to recognize and attack cancer cells. When combined with ipilimumab — which blocks a separate checkpoint called CTLA-4 — the dual blockade produces a stronger anti-tumor immune response than either agent alone.
💊How it's taken▾
Opdivo is given as an intravenous (IV) infusion directly into a vein, usually over about 30 minutes, at a medical facility. The schedule varies by indication — infusions may be given every 2, 3, or 4 weeks. When used with other cancer medicines, Opdivo is typically given on the same day.
- Dosing frequency and duration depend on your specific cancer type, whether Opdivo is used alone or with other drugs, and how your body responds
- Treatment continues until disease progression, recurrence, or unacceptable side effects — in some adjuvant settings, treatment lasts up to about one year
- If you miss a scheduled infusion, contact your oncology team right away to reschedule; do not try to adjust your schedule on your own
🤒Side effects — in detail▾
Like all cancer immunotherapies, Opdivo can cause a range of side effects. The most common ones include:
- Fatigue or weakness
- Rash, itching (pruritus), or other skin changes
- Nausea, diarrhea, vomiting, or constipation
- Musculoskeletal or joint pain
- Decreased appetite
- Cough or shortness of breath
- Fever (pyrexia)
- Upper respiratory tract infections
More serious immune-related reactions — including lung inflammation (pneumonitis), bowel inflammation (colitis), liver damage, kidney problems, and hormone gland disorders — can also occur and require prompt medical attention. Tell your care team immediately if you develop any new or worsening symptoms.
⚠️Warnings & precautions▾
- Immune-mediated adverse reactions: Opdivo can cause the immune system to attack healthy organs — including the lungs, gut, liver, kidneys, skin, and hormone glands. These reactions can be severe or fatal and can occur during or even after treatment ends. Your team will monitor blood tests regularly.
- Infusion reactions: Some patients experience reactions during the infusion (chills, fever, flushing, difficulty breathing). Tell your nurse right away if this happens.
- Allogeneic stem cell transplant (HSCT) risks: Serious and fatal complications have been reported in patients who received a donor stem cell transplant before or after Opdivo treatment.
- Embryo-fetal toxicity: Opdivo can harm an unborn baby. Effective contraception is required during treatment and for 5 months after the last dose.
- Multiple myeloma caution: Opdivo is not recommended in combination with a thalidomide analogue plus dexamethasone for multiple myeloma outside of controlled clinical trials.
🔀What it interacts with▾
While Opdivo does not have traditional drug-drug interactions like many oral medications, there are important combinations and substances your care team needs to know about:
- Ipilimumab: Combining Opdivo with ipilimumab greatly increases the chance of immune-related side effects compared to either drug alone — close monitoring is required
- Cabozantinib: Used with Opdivo for kidney cancer, this combination raises the risk of liver toxicity (elevated liver enzymes)
- Thalidomide analogues + dexamethasone: This combination with Opdivo is not recommended for multiple myeloma outside of clinical trials
- Corticosteroids (e.g., prednisone): These are used to treat immune-related side effects if they develop — do not start or stop them without guidance from your care team
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: Opdivo can cause serious harm to a developing baby, particularly in the second and third trimesters — tell your doctor immediately if you are pregnant or become pregnant during treatment
- Contraception: Women who could become pregnant must use effective birth control during treatment and for 5 months after the last dose; verify pregnancy status before starting
- Breastfeeding: Do not breastfeed during treatment or for 5 months after the last dose due to potential serious harm to the infant
- Autoimmune disease: If you have a condition where your immune system attacks your own body (e.g., lupus, rheumatoid arthritis), tell your doctor — Opdivo may worsen it
- Stem cell or organ transplant history: Inform your care team if you have had or are planning an allogeneic (donor) stem cell transplant — serious complications can occur
- Liver or kidney disease: Mild to moderate liver or kidney impairment does not significantly affect how Opdivo works; severe liver impairment has not been studied — tell your doctor about any organ issues
- Children under 12: Safety and effectiveness have not been established for most uses in patients under 12 years old
- Hepatitis B, Hepatitis C, or HIV: Tell your doctor if you have or have had any of these infections before starting treatment
📡Pharmacodynamics — effects in the body▾
There are no clinically significant relationships between Opdivo exposure levels and its effectiveness or safety when used as monotherapy across the approved dosing schedules, regardless of cancer type. This means that within the approved dose ranges, higher blood levels do not predictably lead to better outcomes or more side effects for single-agent use.
🔬Pharmacokinetics — how your body processes it▾
Opdivo is given intravenously and reaches steady-state blood levels (a stable concentration in the body) by about 12 weeks when dosed every 2 weeks. It has a long elimination half-life of approximately 25 days, meaning it takes several weeks for the body to fully clear the drug after treatment ends. Opdivo is distributed into a relatively small volume in the body (about 6.8 liters), consistent with it staying mostly in the bloodstream and tissues. Age, weight, sex, race, and mild-to-moderate kidney or liver impairment do not meaningfully affect how the body processes Opdivo.
📦How to store it▾
Store under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the original package until time of use. Do not freeze or shake.
📄 Written from Nivolumab Injection’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 →
Supplements & herbs that interact with Nivolumab Injection
1 supplement and herbal product has documented interactions with Nivolumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Nivolumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Opdivo do, and how is it different from regular chemotherapy? ▾
How will I actually receive this medication — do I take it as a pill? ▾
What side effects should I expect, and which ones mean I need to call my doctor right away? ▾
I'm a woman of childbearing age. Is there anything I need to know before starting Opdivo? ▾
Can Opdivo be used together with other cancer drugs? ▾
How long will I be on Opdivo, and how will we know if it's working? ▾
Is Nivolumab Injection available over the counter? ▾
When was Nivolumab Injection first available? ▾
Who makes Nivolumab Injection? ▾
💬 Answers drafted from Nivolumab Injection’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 Injection comes
Nivolumab Injection 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
- Opdivo injection is used intravenously to treat many cancers in adults, including melanoma, non-small cell lung cancer, kidney cancer, bladder cancer, liver cancer, esophageal cancer, gastric cancer, head and neck cancer, colorectal cancer with MSI-H or dMMR features, malignant pleural mesothelioma, and classical Hodgkin lymphoma
- Opdivo injection is approved for use in patients 12 years and older for certain indications, including melanoma and MSI-H or dMMR colorectal cancer, and for classical Hodgkin lymphoma in combination with AVD
- Opdivo injection is used both as a single agent and in combination with other therapies such as ipilimumab, chemotherapy, or cabozantinib, depending on cancer type and stage
- Some uses of Opdivo injection require tumor testing for PD-L1 expression before treatment begins
- Opdivo is administered as an intravenous (IV) infusion, typically over 30 minutes, at a clinic or infusion center
- Opdivo infusions are given every 2, 3, or 4 weeks depending on the indication and treatment regimen — follow your oncologist's prescribed schedule
- When Opdivo is given on the same day as other cancer medicines (such as ipilimumab or chemotherapy), your care team will coordinate the order and timing of each infusion
- Do not self-administer Opdivo; it must be prepared and given by a trained healthcare professional
📊 Nivolumab Injection across the U.S. market
How Nivolumab Injection 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Nivolumab Injection is used
A general measure of how commonly Nivolumab Injection 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 Injection 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 Injection prescribed? Of the 1,596 medications we measure, Nivolumab Injection ranks #776 by Medicaid prescriptions — more than 51% of them.
Utilization by Nivolumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
24 ML nivolumab 10 MG/ML Injection Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1991412
10 ML nivolumab 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1657195
4 ML nivolumab 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1657190
12 ML nivolumab 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2569080
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
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 Injection, 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 4 of 4 listed Nivolumab Injection NDCs with Medicaid activity.
🔍 Compare Nivolumab Injection products
A representative set of FDA-listed product records for Nivolumab Injection — 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 | ||||
| 1 kg/kg | — | Bristol-Myers Squibb Company | BULK INGREDIENT | View NDC → |
| 120 mg/mL | — | Catalent Indiana, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg/mL | Intravenous | E.R. Squibb & Sons, L.L.C. × 16 listings | BLA | View NDC → |
| 1 kg/kg | — | Lotte Biologics USA, LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Swords Laboratories Unlimited Company | BULK INGREDIENT | View NDC → |
Showing 20 of 20 products — FDA National Drug Code Directory. See every product, package size and price: browse all 20 Nivolumab Injection 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 Injection — 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 Injection 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 Injection 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.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1597876 1 dose form · 4 strengths
-
Dose form (SCDF) Injection RxCUI 1657189In current FDA listingsClinical drug / strength (SCD) 4 ML nivolumab 10 MG/MLRxCUI 165719010 ML nivolumab 10 MG/MLRxCUI 165719512 ML nivolumab 10 MG/MLRxCUI 256908024 ML nivolumab 10 MG/MLRxCUI 1991412
Look up RxCUI 1597876 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Nivolumab Injection 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Nivolumab Injection belongs to the Programmed Death Receptor-1 Blocking Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 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.
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.