Ipilimumab Injection
Ipilimumab Injection is an intravenous immunotherapy antibody, given as Yervoy, used alone or with nivolumab to treat 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 (Yervoy) is a specialist IV immunotherapy that blocks CTLA-4, a brake on T-cells (immune cells), so they attack tumors harder; it treats melanoma and several other cancers, usually paired with nivolumab, and has been on the U.S. market since about 2011 as the first drug of its kind. It is harder to tolerate than most immunotherapies, especially with nivolumab, and fatigue, diarrhea, rash and itching are the common complaints. The real risk is the immune system attacking healthy organs, so report new diarrhea, yellow skin or eyes, rash or breathing trouble right away, even after treatment ends. Liver, kidney and thyroid blood tests come before each dose, so keep every appointment.
Clinical pearls
- A new headache or vision change can signal pituitary inflammation, so report it rather than treating it at home with painkillers.
- Severe or lasting diarrhea can mean colitis, so call your oncology team before trying an over-the-counter antidiarrheal.
- Use effective contraception during treatment and for 3 months after the last dose, and avoid breastfeeding for that same stretch.
- Carry a card saying you received Yervoy, since emergency doctors may not suspect immune reactions after treatment ends.
Patient information guide A plain-language walkthrough of Ipilimumab Injection, written from its FDA label.
What Ipilimumab Injection is used for
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Yervoy (ipilimumab) is an intravenous antibody used for these cancers:
- Unresectable or metastatic melanoma in adults and children 12 and older, alone or with nivolumab
- Adjuvant (after surgery) treatment of cutaneous melanoma with lymph node involvement of more than 1 mm after complete resection
- Advanced renal cell carcinoma (intermediate or poor risk), first-line with nivolumab
- MSI-H or dMMR colorectal cancer (unresectable or metastatic) in adults and children 12 and older, with nivolumab
- Hepatocellular carcinoma, first-line with nivolumab, or after prior sorafenib with nivolumab
- Metastatic non-small cell lung cancer, with nivolumab (PD-L1 at least 1%), or with nivolumab and 2 cycles of platinum chemotherapy, without EGFR or ALK changes
- Unresectable malignant pleural mesothelioma, first-line with nivolumab
- Unresectable advanced or metastatic esophageal squamous cell carcinoma with PD-L1 expression, first-line with nivolumab
How Ipilimumab Injection works
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Ipilimumab is a monoclonal antibody that attaches to CTLA-4, a protein that normally slows down T-cells. Blocking it lets T-cells activate and multiply, including those that infiltrate tumors.
It may also reduce the activity of regulatory T-cells, which can further strengthen the immune attack on cancer.
Ipilimumab Injection dosage
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Yervoy is given by a healthcare professional as an IV infusion. Each dose runs about 30 minutes. Schedules differ by cancer type.
- Every 3 weeks for a limited number of doses for melanoma, kidney, colorectal and liver cancers
- Every 6 weeks for lung, mesothelioma and esophageal cancers
- Given on the same day as nivolumab when combined
Food does not apply to IV treatment. Your care team handles scheduling, so ask them what to do if you miss an appointment.
Dosing details from the FDA-approved label
From the Ipilimumab Injection 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.
- Unresectable or metastatic melanoma (single agent)
- 3 mg/kg every 3 weeks, administered as a 30-minute intravenous infusion
- Maximum: Maximum of 4 doses
- Unresectable or metastatic melanoma (in combination with nivolumab)
- 3 mg/kg every 3 weeks with nivolumab 1 mg/kg, YERVOY immediately following nivolumab on the same day, for 4 doses
- After completing 4 doses of the combination, administer nivolumab as a single agent
- Maximum: Maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier
- Adjuvant treatment of melanoma
- 3 mg/kg every 3 weeks for 4 doses, followed by 3 mg/kg every 12 weeks for up to 4 additional doses
- Maximum: Every 3 weeks up to a maximum of 4 doses; every 12 weeks for up to 4 additional doses
- Advanced renal cell carcinoma
- 1 mg/kg every 3 weeks immediately following nivolumab 3 mg/kg on the same day, for 4 doses
- After completing 4 doses of the combination, administer nivolumab as a single agent
- Maximum: Maximum of 4 doses
- MSI-H or dMMR metastatic colorectal cancer: adult patients and pediatric patients age 12 years and older weighing 40 kg or more
- 1 mg/kg every 3 weeks immediately following nivolumab 240 mg on the same day
- After completing the combination, administer nivolumab as a single agent
- Maximum: Maximum of 4 doses
- Weighing 40 kg or greater
- MSI-H or dMMR metastatic colorectal cancer: pediatric patients age 12 years and older weighing less than 40 kg
- 1 mg/kg every 3 weeks immediately following nivolumab 3 mg/kg on the same day
- After completing the combination, administer nivolumab as a single agent
- Maximum: Maximum of 4 doses
- Weighing less than 40 kg
- Hepatocellular carcinoma
- 3 mg/kg intravenously over 30 minutes immediately following nivolumab 1 mg/kg intravenously over 30 minutes on the same day, every 3 weeks
- After completing up to 4 doses of the combination, administer nivolumab as a single agent
- Maximum: Up to 4 doses
- Metastatic non-small cell lung cancer
- 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks
- Or the same with 2 cycles of platinum-doublet chemotherapy
- Until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression
- Malignant pleural mesothelioma
- 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks
- Until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression
- Esophageal squamous cell carcinoma
- 1 mg/kg every 6 weeks with nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks
- Until disease progression, unacceptable toxicity, or up to 2 years
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Administer by intravenous infusion after dilution based upon recommended infusion rate for each indication. (2) • Unresectable or Metastatic Melanoma : ∘ YERVOY 3 mg/kg every 3 weeks for a maximum of 4 doses. (2.2) ∘ YERVOY 3 mg/kg immediately following nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer nivolumab as a single agent as recommended in the Full Prescribing Information for nivolumab. (2.2) • Adjuvant Treatment of Melanoma : YERVOY 3 mg/kg every 3 weeks for 4 doses, followed by 3 mg/kg every 12 weeks for up to 4 additional doses. (2.2) • Advanced Renal Cell Carcinoma : YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer nivolumab as a single agent as recommended in Full Prescribing Information for nivolumab. (2.2) • Treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in combination with nivolumab : ∘ Adult and pediatric patients weighing 40 kg or greater: YERVOY 1 mg/kg immediately following nivolumab 240 mg on the same day every 3 weeks for a maximum of 4 doses. After completing the combination, administer nivolumab as a single agent as recommended in Full Prescribing Information for nivolumab. (2.2) ∘ Pediatric patients weighing less than 40 kg: YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day every 3 weeks for a maximum of 4 doses. After completing the combination, administer nivolumab as a single agent as recommended in Full Prescribing Information for nivolumab. ( 2.2 ) • Hepatocellular Carcinoma : YERVOY 3 mg/kg intravenously over 30 minutes immediately following nivolumab 1 mg/kg intravenously over 30 minutes on the same day, every 3 weeks for up to 4 doses. After completing up to 4 doses of the combination, administer nivolumab as a single agent as recommended in Full Prescribing Information for nivolumab. (2.2) • Metastatic non-small cell lung cancer : ∘ YERVOY 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks. (2.2) ∘ YERVOY 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks and 2 cycles of platinum-doublet chemotherapy. (2.2) • Malignant pleural mesothelioma : YERVOY 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ipilimumab Injection side effects
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Common side effects include:
Common side effects
- Fatigue
- Diarrhea
- Rash
- Itching (pruritus)
- Nausea
- Headache
- Fever, cough and decreased appetite (more common with nivolumab)
- Muscle or joint pain (with nivolumab)
- With nivolumab: muscle or joint pain, fever, cough, decreased appetite, vomiting, abdominal pain, constipation, underactive thyroid
When to get medical help
- Call your care team right away for severe or persistent diarrhea or colitis (inflamed bowel), which can be fatal.
- Report yellowing of the skin or eyes or liver problems, which may signal hepatitis (liver inflammation).
- Report severe rash, blistering or peeling skin, which can signal serious skin reactions.
- Tell your team about headache, vision changes or hormone-related symptoms, which can signal pituitary, adrenal or thyroid problems.
- Report new cough or breathing trouble (possible pneumonitis, lung inflammation) or kidney problems.
- Tell staff right away about reactions during the infusion; severe ones require stopping treatment.
- Immune reactions can start at any time, even after treatment ends, so report new symptoms promptly.
Serious immune reactions affecting the bowel, liver, skin, hormone glands or lungs need prompt medical attention.
Ipilimumab Injection warnings and precautions
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- Severe and fatal immune-mediated reactions: they can affect any organ, including the bowel, liver, skin, hormone glands, lungs and kidneys, during or after treatment.
- Blood tests are checked at baseline and before each dose.
- Severe reactions may require pausing or permanently stopping treatment, usually with steroids.
- Infusion reactions: mild or moderate ones may mean slowing or interrupting the infusion. Severe ones mean stopping.
- Stem cell transplant: fatal and serious complications can occur after allogeneic transplant before or after Yervoy.
- Fetal harm: Yervoy can harm an unborn baby.
Ipilimumab Injection interactions
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Few specific interactions are described, but these matter:
- Vemurafenib: serious liver enzyme elevations occurred in a small trial, and safety is not established.
- Nivolumab: commonly paired, but the combination increases immune-related side effects.
- Corticosteroids and other immunosuppressants: used to treat immune reactions from Yervoy.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ipilimumab Injection
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- Tell your doctor if you are pregnant or planning pregnancy. Pregnancy status is checked before starting.
- Use effective contraception during treatment and for 3 months after the last dose.
- Do not breastfeed during treatment and for 3 months after the last dose.
- Tell your doctor about any stem cell transplant history or plans.
- Children under 12 have not been shown to be safe or effective for these uses.
- Adults 75 and older had higher rates of stopping treatment for side effects in some studies.
- Not studied in moderate or severe liver impairment.
What Ipilimumab Injection does in the body
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Ipilimumab blocks CTLA-4 and increases T-cell activation and multiplication, including tumor-infiltrating T-cells. It may also reduce regulatory T-cell function, raising overall immune responsiveness against tumors.
How your body processes Ipilimumab Injection
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Ipilimumab's levels in the body rise in proportion to the dose. With dosing every 3 weeks, steady levels are reached by the third dose. Its half-life is about 15 days. Clearance rises with body weight, which is why dosing is weight-based. Age, sex, kidney impairment (GFR 15 or higher) and mild liver impairment had no important effect.
How to store Ipilimumab Injection
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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 the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Ipilimumab Injection: pharmacist answers to common questions
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 is Yervoy for?
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How will I get it?
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What side effects are normal?
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Which symptoms should I call about right away?
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Will I need blood tests?
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Is it safe in pregnancy?
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Is Ipilimumab Injection available over the counter?
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When was Ipilimumab Injection 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 Ipilimumab Injection on HelloPharmacist
Ipilimumab Injection forms and strengths (how it 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ipilimumab Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Yervoy is used for unresectable or metastatic melanoma, alone or with nivolumab.
- Yervoy is used after surgery for melanoma involving regional lymph nodes.
- Yervoy is used with nivolumab for renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma and esophageal cancer.
- Yervoy is given by intravenous infusion after dilution.
- Yervoy is given as a 30-minute infusion.
- Yervoy is given on the same day as nivolumab or other combination medicines.
- Yervoy is dosed by body weight, with schedules set by your prescriber.
Ipilimumab Injection on the U.S. market: products, makers and brands
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.
1 company lists 2 Ipilimumab Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2011. Brand names on the directory include Yervoy; the rest are generics.
How widely Ipilimumab Injection is used (Medicaid data)
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 1,601 medications we measure, Ipilimumab Injection ranks #1,105 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. × 2 listings | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Ipilimumab Injection NDCs →
Ipilimumab Injection 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 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.
Ipilimumab Injection FDA approval history
How Ipilimumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ipilimumab Injection 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 no Ipilimumab recalls since July 2021.
✅No Ipilimumab recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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
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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.
Ipilimumab Injection supply and 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.
Ipilimumab Injection brand names
Ipilimumab Injection is sold under one brand name in the FDA directory — Yervoy. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ipilimumab Injection: manufacturers and labelers
One company lists Ipilimumab Injection 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.
Ipilimumab Injection drug class (RxNorm)
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.
Sources for this Ipilimumab Injection 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 →