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Axitinib

Published: July 26, 2026Updated: July 26, 2026

Axitinib is an oral targeted therapy medication that belongs to the class of drugs called tyrosine kinase inhibitors. It is primarily used to treat advanced renal cell carcinoma (kidney cancer) in patients who have not responded to prior systemic therapy. The medication works by blocking specific enzymes that promote tumor growth and blood vessel formation.

Quick summary

Axitinib is a targeted cancer therapy used for advanced kidney cancer that works by inhibiting blood vessel growth to tumors.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
L01EK01
RxNorm
1242999
Generic
Axitinib
Class
atc-l01
Brands
Inlyta
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

adult (standard)tablet
Usual dose
5mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
5mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
5mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Dose significantly exceeding recommended 5mg twice daily may lead to serious toxicity
Chronic overdose: Prolonged exposure above recommended dosing may result in cumulative adverse effects
Immediate actions
Monitor vital signs, provide supportive care, gastric lavage if within 1 hour of ingestion
Antidote
No specific antidote available(Supportive care is primary treatment approach)
Poison Control: 1-800-222-1222

Special Populations

7 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks to the fetus

Monitor

regular fetal monitoring and ultrasound assessments

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue therapy if pregnancy occurs

Monitor

fetal growth monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

avoid

Key Recommendations

do not breastfeed during treatment and for at least 2 weeks after last dose

Monitor

no specific monitoring required

Use of this medication in this population requires careful consideration of risks and benefits.

?

pediatric_age

children under 18
unknown
FDA Category
C
Dose Adjustment

not established

Key Recommendations

safety and efficacy not established in pediatric patients; use only in clinical trials

Monitor

close monitoring in clinical trial settings

⚠

geriatric

elderly 65 and older
caution
FDA Category
C
Dose Adjustment

no specific adjustment

Key Recommendations

no overall differences in safety or efficacy observed but monitor for increased sensitivity

Monitor

monitor blood pressure and for adverse reactions

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
C
Dose Adjustment

use with caution

Key Recommendations

no dose adjustment for mild to moderate impairment; use caution in severe impairment

Monitor

monitor renal function regularly

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate
caution
FDA Category
C
Dose Adjustment

reduce dose

Key Recommendations

reduce starting dose to approximately half in moderate hepatic impairment

Monitor

monitor liver function tests closely

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2012

FDA approval for advanced renal cell carcinoma

drug_classWHO
2023

Drug class

Value:Tyrosine kinase inhibitor

VEGF receptor inhibitor classification

mechanismFDA
2023

Mechanism of action

Value:VEGF receptor 1-3 inhibition

Primary pharmacologic action

usageNCCN
2023

Primary indication

Value:Advanced renal cell carcinoma

FDA-approved therapeutic use

Treatment of advanced renal cell carcinoma (kidney cancer) in patients who have failed prior systemic therapy with a cytokine or anti-angiogenic agent.

Axitinib inhibits vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3), blocking the signaling pathways that promote tumor angiogenesis, growth, and metastatic progression.

May cause hypertension, thyroid problems, and increased risk of bleeding or gastrointestinal perforation. Regular monitoring of blood pressure, thyroid function, and liver enzymes is required. Should be taken on an empty stomach. May interact with strong CYP3A4 inhibitors and inducers.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

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.

Medical Disclaimer

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