Ipilimumab Injection
Ipilimumab injection (Yervoy) is an immune checkpoint inhibitor used intravenously to treat several advanced or metastatic cancers, including melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal cancer.
🧬 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 →
📖 Ipilimumab Injection: Patient Information Guide
A plain-language walkthrough of Ipilimumab 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▾
Ipilimumab injection (Yervoy) is an intravenous immunotherapy approved for multiple advanced or metastatic cancers. Below are the supported uses:
- Yervoy as a single agent or with nivolumab: unresectable or metastatic melanoma in adults and patients aged 12 and older
- Yervoy as a single agent: adjuvant treatment of cutaneous melanoma with lymph node involvement (more than 1 mm) after complete surgical resection in adults
- Yervoy in combination with nivolumab: first-line treatment of intermediate or poor risk advanced renal cell carcinoma in adults
- Yervoy in combination with nivolumab: unresectable or metastatic MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient) colorectal cancer in adults and patients aged 12 and older, as confirmed by an FDA-authorized test
- Yervoy in combination with nivolumab: first-line treatment of unresectable or metastatic hepatocellular carcinoma (liver cancer) in adults, or in adults previously treated with sorafenib
- Yervoy in combination with nivolumab: first-line treatment of metastatic non-small cell lung cancer expressing PD-L1 (≥1%) with no EGFR or ALK alterations in adults
- Yervoy in combination with nivolumab and platinum-doublet chemotherapy: first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK alterations in adults
- Yervoy in combination with nivolumab: first-line treatment of unresectable malignant pleural mesothelioma in adults
- Yervoy in combination with nivolumab: first-line treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma expressing PD-L1 (≥1) in adults
⚙️How it works▾
Ipilimumab is a monoclonal antibody — a lab-made protein — that targets and blocks CTLA-4, a molecule that normally puts the brakes on immune T-cells. By blocking CTLA-4, ipilimumab allows T-cells to become more active and multiply, including T-cells that infiltrate tumors and attack cancer cells. It may also reduce the activity of regulatory T-cells (cells that dampen immune responses), leading to a broader boost in the immune system's ability to recognize and destroy cancer.
💊How it's taken▾
Yervoy is given as a 30-minute intravenous (IV) infusion by a healthcare professional — it is never taken by mouth or self-administered at home. Depending on the cancer being treated and whether Yervoy is used alone or with nivolumab (and sometimes chemotherapy), it may be scheduled every 3 weeks or every 6 weeks.
- When used as a single agent for melanoma, it is typically given every 3 weeks for up to 4 doses, sometimes followed by less frequent maintenance doses for adjuvant treatment
- When combined with nivolumab, Yervoy is given on the same day as nivolumab, immediately after the nivolumab infusion
- Your oncology team will set your exact schedule — do not adjust or miss doses without talking to them first
🤒Side effects — in detail▾
The most common side effects reported in 20% or more of patients include:
- Fatigue
- Diarrhea
- Rash and skin itching (pruritus)
- Nausea and vomiting
- Decreased appetite
- Muscle and joint pain
- Fever (pyrexia)
- Headache
- Cough and shortness of breath
- Constipation
- Hypothyroidism (underactive thyroid)
More serious immune-related reactions — including severe colitis, hepatitis, skin reactions, lung inflammation, kidney problems, and hormone gland disorders — can be life-threatening. Tell your care team immediately about any new or worsening symptoms; early treatment is critical.
⚠️Warnings & precautions▾
- Immune-mediated adverse reactions: Because Yervoy activates the immune system, it can cause serious or fatal inflammation in almost any organ — including the colon, liver, lungs, kidneys, skin, and hormone glands. These reactions can occur during treatment or weeks after it ends. Regular lab monitoring is required before every dose.
- Infusion-related reactions: Some patients experience reactions during or after the IV infusion. Severe or life-threatening infusion reactions require stopping the infusion immediately.
- Allogeneic stem cell transplant complications: Patients who receive a donor stem cell transplant (allogeneic HSCT) before or after Yervoy treatment face a risk of serious and potentially fatal transplant complications.
- Embryo-fetal toxicity: Yervoy can cause serious harm to a developing baby. Pregnant women should not receive this medicine. Effective contraception is required during treatment and for 3 months after the last dose.
- Older adults (75+): Higher rates of serious side effects and treatment discontinuation have been seen in patients 75 years and older for some indications — discuss this risk with your doctor.
🔀What it interacts with▾
Ipilimumab has a limited number of documented drug interactions, but the following are important to know:
- Nivolumab: When given together, the combination can affect how quickly each drug is cleared from the body. Your care team accounts for this when determining your regimen — do not adjust doses on your own.
- Vemurafenib: Combining Yervoy with vemurafenib has caused serious liver toxicity (severe elevations in liver enzymes) in clinical testing. This combination is not an established or approved regimen.
- Corticosteroids and immunosuppressants: These may be needed to manage immune-related side effects, but using strong immunosuppressants before starting Yervoy (e.g., for organ transplants) can complicate treatment — always disclose all medications to your doctor.
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: Yervoy can cause fetal harm, particularly in the second and third trimesters. Confirm you are not pregnant before starting, and use effective contraception during treatment and for 3 months after your last dose.
- Breastfeeding: Do not breastfeed during Yervoy treatment or for 3 months after the last dose, as the drug may pass into breast milk and harm a nursing infant.
- Children under 12: Yervoy's safety and effectiveness have not been established in patients younger than 12 for any indication.
- Autoimmune disease or organ transplant: Patients with active autoimmune disease or those on immunosuppressants for organ transplants were excluded from key clinical trials — discuss your history with your doctor before starting.
- Liver impairment: Yervoy has not been studied in patients with moderate or severe liver impairment. Mild liver impairment does not meaningfully affect how the drug is processed.
- Stem cell transplant history: If you have had or plan to have an allogeneic (donor) stem cell transplant, serious complications have been reported — tell your oncologist.
- Older adults: Patients 75 and older may experience higher rates of serious side effects and may be more likely to stop treatment due to adverse reactions.
📡Pharmacodynamics — effects in the body▾
By blocking the CTLA-4 checkpoint, ipilimumab removes a key inhibitory signal on T-cells, leading to increased T-cell activation and proliferation — including the expansion of T-cells that infiltrate and attack tumors. It also appears to reduce the function of regulatory T-cells, which normally suppress immune activity, resulting in a broader and more sustained anti-tumor immune response.
🔬Pharmacokinetics — how your body processes it▾
Ipilimumab is given intravenously and follows predictable (linear) pharmacokinetics across the studied dose range. It reaches steady-state blood concentrations by the third dose, with minimal accumulation over time. The drug has a mean terminal half-life of about 15.4 days, meaning it takes roughly two weeks for the body to clear half of a given dose. Age, sex, kidney function (down to a GFR of 15), and mild liver impairment do not meaningfully change how the body clears ipilimumab, though clearance does increase with higher body weight, which is why dosing is based on body weight (mg/kg).
📦How to store it▾
Store YERVOY under refrigeration at 2°C to 8°C (36°F to 46°F). storing in the original carton until time of use. Do not freeze or shake.
📄 Written from Ipilimumab 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 →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ipilimumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Yervoy and why did my doctor prescribe it? ▾
How will I receive this medication, and how often do I come in? ▾
What side effects should I expect, and which ones should make me call my doctor right away? ▾
Is it safe to get pregnant or breastfeed while on Yervoy? ▾
I'm 70 years old — is Yervoy safe for me? ▾
My doctor mentioned I might need lab tests before every dose — why is that? ▾
Is Ipilimumab Injection available over the counter? ▾
When was Ipilimumab Injection first available? ▾
Who makes Ipilimumab Injection? ▾
💬 Answers drafted from Ipilimumab 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 Ipilimumab Injection comes
Ipilimumab 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
- Yervoy is used intravenously as a single agent or with nivolumab to treat unresectable or metastatic melanoma in adults and patients aged 12 and older
- Yervoy is used intravenously as adjuvant therapy in adults with cutaneous melanoma that has spread to regional lymph nodes after complete surgical removal
- Yervoy is used intravenously in combination with nivolumab for advanced renal cell carcinoma, hepatocellular carcinoma, MSI-H/dMMR metastatic colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma in adults
- Yervoy in combination with nivolumab is approved for MSI-H or dMMR metastatic colorectal cancer in patients aged 12 and older
- Yervoy is administered by a healthcare professional as a 30-minute intravenous infusion in a clinical setting
- Yervoy is given on a schedule of every 2, 3, or 6 weeks depending on the cancer type and whether it is combined with other treatments — follow your care team's exact plan
- Yervoy is always given after dilution; it is not self-administered at home
- When Yervoy is given with nivolumab, both infusions are administered on the same day, with Yervoy given immediately after nivolumab
📊 Ipilimumab Injection across the U.S. market
How Ipilimumab 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 Ipilimumab Injection is used
A general measure of how commonly Ipilimumab 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 Ipilimumab 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 Ipilimumab Injection prescribed? Of the 1,594 medications we measure, Ipilimumab Injection ranks #1,104 by Medicaid prescriptions — more than 31% of them.
Utilization by Ipilimumab 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.
10 ML ipilimumab 5 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 1657012
40 ML ipilimumab 5 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 1657005
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 Ipilimumab 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 2 of 2 listed Ipilimumab Injection NDCs with Medicaid activity.
🔍 Compare Ipilimumab Injection products
A representative set of FDA-listed product records for Ipilimumab 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 | ||||
| 5 mg/mL | Intravenous | E.R. Squibb & Sons, L.L.C. × 10 listings | BLA | View NDC → |
| 1 kg/kg | — | Lotte Biologics USA, LLC | BULK INGREDIENT | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Ipilimumab 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 Ipilimumab 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 Ipilimumab 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 Ipilimumab 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 1094833 2 dose forms · 3 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 1094835In current FDA listingsClinical drug / strength (SCD) 5 MG/MLRxCUI 1094836 -
Dose form (SCDF) Injection RxCUI 1657004In current FDA listingsClinical drug / strength (SCD) 10 ML ipilimumab 5 MG/MLRxCUI 165701240 ML ipilimumab 5 MG/MLRxCUI 1657005
Look up RxCUI 1094833 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 Ipilimumab 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
Ipilimumab Injection belongs to the CTLA-4-directed 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.