Cemiplimab
Cemiplimab is an immunotherapy medication classified as a PD-1 inhibitor that helps restore the immune system's ability to recognize and attack cancer cells. It is primarily used to treat certain skin cancers including cutaneous squamous cell carcinoma and basal cell carcinoma, as well as non-small cell lung cancer. By blocking the PD-1 pathway, which tumors exploit to evade immune detection, Cemiplimab enables T-cells to mount an effective anti-tumor response.
Cemiplimab is an anti-PD-1 immunotherapy drug used to treat certain skin cancers and lung cancer by helping the immune system attack tumor cells.
Key facts at a glance
- ATC
- L01FF06
- RxNorm
- 2058826
- Generic
- Cemiplimab
- Class
- atc-l01
- Brands
- Libtayo
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- 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
- 350mg every 3 weeks
- Maximum
- consult physician
- Frequency
- every 21 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 350mg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 14 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 350mg every 3 weeks
- Maximum
- consult physician
- Frequency
- every 21 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
generalavoid if possible
avoid use during pregnancy unless benefits outweigh risks to the mother outweigh potential risks to fetus
regular fetal monitoring recommended if used
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
generaldiscontinue breastfeeding
discontinue breastfeeding during treatment and for at least 4 months after last dose
monitor infant for signs of immune-mediated reactions
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
use only if benefits outweigh risks; limited efficacy and safety data available for pediatric patients
close monitoring for immune-mediated adverse events
geriatric
elderlyno specific adjustment
no dose adjustment required but monitor for increased risk of adverse events including immune-mediated reactions
regular assessment of organ function and immune-related adverse events
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno adjustment needed
no dose adjustment needed for mild to moderate renal impairment
routine renal function monitoring
renal_impairment
severeuse with caution
use with caution; limited data available for severe renal impairment
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno adjustment needed
no dose adjustment needed for mild hepatic impairment
routine liver function monitoring
hepatic_impairment
moderate severeuse with caution
use with caution in moderate to severe hepatic impairment; limited clinical data
close monitoring of liver function and for signs of hepatotoxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval date
First FDA approval for Cemiplimab (Libtayo)
Drug class
Monoclonal antibody immune checkpoint inhibitor
Approved indications
Therapeutic indications for Cemiplimab
Cemiplimab is approved for metastatic or locally advanced cutaneous squamous cell carcinoma in patients not candidates for curative surgery or radiation, locally advanced or metastatic basal cell carcinoma, and first-line treatment of advanced non-small cell lung cancer with PD-L1 expression ≥50%.
Cemiplimab is a monoclonal antibody that binds to the PD-1 receptor on T-cells, blocking interaction with PD-L1 and PD-L2 ligands. This removes the immunosuppressive signal that tumors use to evade immune detection, restoring T-cell proliferation and cytokine production to fight cancer.
Cemiplimab can cause immune-related adverse events affecting organs such as lungs, liver, kidneys, and endocrine glands. Common side effects include fatigue, rash, and musculoskeletal pain. Patients require monitoring for immune-mediated toxicity and may need corticosteroids or other immunosuppressants for management.
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