Durvalumab
Durvalumab is an immunotherapy medication classified as a monoclonal antibody that targets programmed cell death ligand-1 (PD-L1). It works by blocking the PD-L1 pathway, which allows the immune system to better recognize and attack cancer cells. This medication is primarily used to treat various cancers, including non-small cell lung cancer, small cell lung cancer, bladder cancer, biliary tract cancer, and hepatocellular carcinoma.
Durvalumab is a PD-L1 inhibitor monoclonal antibody used to treat several cancers by helping the immune system attack tumor cells.
Key facts at a glance
- ATC
- L01FF03
- RxNorm
- 1919503
- Generic
- Durvalumab
- Class
- atc-l01
- Brands
- Imfinzi
- 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
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second and third trimesteravoid if possible
avoid use during pregnancy especially in later trimesters
regular fetal monitoring including growth assessments
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
no specific monitoring required
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly over 65no specific dose adjustment required
use with caution and monitor for adverse reactions
regular monitoring of renal and hepatic function
Use with caution and monitor for adverse effects.
pediatric_age
children under 18not recommended
not approved for use in pediatric patients under 18 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild moderateno dose adjustment needed
no dose adjustment required for mild to moderate renal impairment
routine monitoring of renal function
renal_impairment
severeuse with caution
limited data available for severe renal impairment; use with caution
close monitoring of renal function and adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno dose adjustment needed
no dose adjustment required for mild hepatic impairment
routine monitoring of liver function tests
hepatic_impairment
moderate severeuse with caution
limited data available for moderate to severe hepatic impairment; use with caution
close monitoring of liver function tests and adverse effects
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approved Durvalumab under the brand name Imfinzi
Drug class
Monoclonal antibody immunotherapy drug
Common uses
Approved therapeutic indications
Mechanism of action
Binds to PD-L1 and blocks interaction with PD-1 and CD80
Durvalumab is approved for treating non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer, hepatocellular carcinoma, and previously treated urothelial carcinoma. It may be used alone or in combination with other therapies depending on the cancer type and stage.
Durvalumab is a monoclonal antibody that binds to PD-L1 on tumor cells and immune cells in the tumor microenvironment. By blocking PD-L1, it prevents the ligand from inhibiting T-cell function and activation, allowing the immune system to recognize and destroy cancer cells more effectively.
Durvalumab is administered intravenously and may cause immune-related adverse reactions affecting various organs including the lungs, liver, colon, and endocrine glands. Patients should be monitored for signs of immune-mediated toxicity. Common side effects include fatigue, musculoskeletal pain, decreased appetite, and rash. Treatment should be supervised by oncologists experienced in immunotherapy.
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