Ipilimumab
Ipilimumab is an immunotherapy drug used to treat advanced melanoma and several other cancers including renal cell carcinoma, colorectal cancer, and hepatocellular carcinoma. It works by blocking the CTLA-4 protein, which acts as an immune system brake, thereby enhancing the body's natural ability to recognize and attack cancer cells.
A monoclonal antibody immunotherapy that blocks CTLA-4 to unleash the immune system against cancer cells.
Key facts at a glance
- ATC
- L01FX04
- RxNorm
- 1094833
- Generic
- Ipilimumab
- Class
- atc-l01
- Brands
- Yervoy
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection, solution
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 3 mg/kg every 3 weeks for 4 doses
- Maximum
- consult physician
- Frequency
- every 3 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 3 mg/kg every 3 weeks for 4 doses
- Maximum
- consult physician
- Frequency
- every 3 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 3 mg/kg every 3 weeks for 4 doses
- Maximum
- consult physician
- Frequency
- every 3 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; discuss potential fetal harm
regular fetal monitoring via ultrasound
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
discontinue therapy if pregnancy occurs; consider risks vs benefits
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near term; consider risks of early delivery
regular fetal monitoring and contraction monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 3 months after last dose
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
12 years and olderno standard adjustment
approved for pediatric patients 12 years and older with BRAF V600E mutation positive unresectable or metastatic melanoma; monitor for immune-mediated adverse reactions
close monitoring for immune-mediated toxicities
Use with caution and monitor for adverse effects.
geriatric
65 years and olderno specific dose adjustment
no overall differences in efficacy observed; monitor closely for adverse reactions
regular assessment of organ function and immune-mediated toxicities
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno dose adjustment required
no dose adjustment needed for mild to moderate renal impairment
standard monitoring
renal_impairment
severeno specific adjustment in labeling
use with caution; limited data available
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno dose adjustment required
no dose adjustment needed for mild hepatic impairment
standard monitoring
hepatic_impairment
moderate severeuse with caution
use with caution in moderate to severe hepatic impairment; monitor liver function closely
frequent liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval for metastatic melanoma
Drug class
Immunotherapy agent classification
Common uses
Approved therapeutic indications
Mechanism of action
Pharmacological mechanism of action
Ipilimumab is primarily indicated for unresectable or metastatic melanoma (advanced skin cancer). It is also approved for renal cell carcinoma (kidney cancer), microsatellite instability-high or mismatch repair deficient colorectal cancer, hepatocellular carcinoma (liver cancer), and malignant pleural mesothelioma. It may be used as a single agent or in combination with other immunotherapies such as nivolumab.
Ipilimumab is a monoclonal antibody that binds specifically to CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4), a protein on T-cells that normally inhibits immune responses. By blocking CTLA-4, the drug prevents it from interacting with CD80/CD86 ligands on antigen-presenting cells, effectively removing the 'brake' on T-cell activation and proliferation. This enhanced immune response enables T-cells to better recognize and destroy cancer cells.
Ipilimumab is administered as an intravenous infusion, typically every 3 weeks for a limited number of doses. Due to its mechanism of action, it can cause severe immune-related adverse effects affecting the skin, liver, intestines, kidneys, lungs, and endocrine glands, requiring close monitoring. Treatment should be managed by oncologists experienced with immunotherapy. Baseline evaluations and regular assessments are essential to detect and manage potential immune-related complications promptly.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy