Apalutamide
Apalutamide is an androgen receptor inhibitor used in the treatment of prostate cancer. It works by binding to the androgen receptor and blocking its ability to function, thereby slowing the growth of cancer cells that depend on male hormones.
Apalutamide is an oral antiandrogen medication used to treat prostate cancer by blocking androgen receptor signaling.
Key facts at a glance
- ATC
- L02BB05
- RxNorm
- 1999574
- Generic
- Apalutamide
- Class
- atc-l02
- Brands
- Erleada
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- 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
- 240mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not approved for pediatric use
- Maximum
- consult physician
- Frequency
- N/A
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 240mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
6 groupspregnancy
all trimestersavoid use
contraindicated in pregnancy and women of childbearing potential. based on mechanism of action (androgen receptor inhibition), it can cause fetal harm and potential loss of pregnancy.
n/a - avoid use
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid use
not recommended during breastfeeding. it is unknown whether apalutamide or its metabolites are excreted in human milk.
n/a - avoid use
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
not indicated for pediatric patients. safety and efficacy not established in patients under 18 years of age.
n/a - not studied
geriatric
elderly over 65no specific adjustment required
no dose adjustment required based on age alone. however, elderly patients may have increased sensitivity to side effects, particularly falls and fractures.
regular assessment of fall risk and fracture prevention
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution - no specific dose recommendation
use with caution in patients with severe renal impairment. apalutamide and its metabolites are minimally excreted renally, but exposure may be increased.
monitor renal function and for adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severeuse with caution
use with caution in patients with moderate to severe hepatic impairment. apalutamide is primarily metabolized in the liver.
monitor liver function tests and for adverse effects
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for non-metastatic castration-resistant prostate cancer
Drug class
Pharmacological classification
Primary indication
Therapeutic indication
Mechanism of action
Pharmacodynamics
Apalutamide is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
Apalutamide binds directly to the ligand-binding domain of the androgen receptor, inhibiting AR nuclear translocation, DNA binding, and AR-mediated transcription, thereby preventing androgen-driven tumor growth.
Common side effects include fatigue, rash, and fractures. Apalutamide may cause fetal harm and should not be used by pregnant women. Regular monitoring and adherence to concurrent androgen deprivation therapy is essential during treatment.
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