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Avacopan

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

Avacopan is an oral medication classified as a complement 5a receptor (C5aR) antagonist used to treat certain autoimmune conditions affecting blood vessels. It is specifically approved for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), which are types of ANCA-associated vasculitis. By blocking the C5a receptor, avacopan prevents neutrophil activation and migration, reducing inflammation and damage to blood vessels.

Quick summary

Avacopan is a C5a receptor antagonist used to treat ANCA-associated vasculitis (GPA and MPA) by blocking neutrophil-mediated inflammation.

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

Key facts at a glance

ATC
L04AJ05
RxNorm
2572100
Generic
Avacopan
Class
atc-l04
Brands
Tavneos
Availability
rx
Lactation
unknown
Routes
oral
Forms
capsule
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
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 900 mg may cause serious toxicity - approximately 15 times the recommended daily dose
Chronic overdose: Prolonged exposure above recommended 60 mg daily dose may lead to cumulative toxicity
Immediate actions
seek immediate medical attention, contact poison control, monitor vital signs, supportive care
Antidote
no specific antidote(supportive care only - no specific antidote available)
Poison Control: 1-800-222-1222

Special Populations

9 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless potential benefits justify potential fetal risk

Monitor

regular fetal monitoring and ultrasound assessments

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

✗

pregnancy

second third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue therapy if pregnancy detected unless clearly necessary

Monitor

continuous fetal monitoring throughout pregnancy

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

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

do not breastfeed during avacopan treatment and for at least 5 days after last dose

Monitor

monitor infant for any adverse effects

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

?

pediatric_age

under 18 years
unknown
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

safety and efficacy not established in pediatric patients - avoid use in children and adolescents

Monitor

not applicable - not studied

⚠

geriatric

elderly 65 years and older
caution
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

use standard adult dosing - no overall differences in safety or efficacy observed but monitor for comorbidities

Monitor

regular assessment of renal and hepatic function

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild to moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no clinically significant effect on pharmacokinetics - standard dosing applies

Monitor

routine monitoring of renal function

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available - use with caution and close monitoring

Monitor

frequent monitoring of renal function and clinical response

Use with caution and monitor for adverse effects.

✓

hepatic_impairment

mild to moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no clinically significant effect on pharmacokinetics - standard dosing applies

Monitor

routine monitoring of liver function tests

⚠

hepatic_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available - use only if benefits outweigh potential risks

Monitor

frequent monitoring of liver function tests and clinical response

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:C5a receptor inhibitor

Complement inhibitor class information

prescribingFDA
2023

FDA approval year

Value:2021

Regulatory approval information

usageFDA
2023

Primary indications

Value:Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

Therapeutic indications

mechanismFDA
2023

Mechanism of action

Value:Complement C5a receptor antagonist

Pharmacological mechanism

Avacopan is used for the treatment of severe active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in adult patients. These are rare autoimmune conditions that cause inflammation of small blood vessels (vasculitis).

Avacopan works as a selective antagonist of the complement 5a receptor (C5aR). It blocks the interaction between C5a and its receptor, preventing C5a-mediated neutrophil activation, adhesion, and migration. This reduces the inflammatory response that damages blood vessels in vasculitis.

Avacopan is typically taken orally twice daily with food. It is often used in combination with other immunosuppressive therapies such as rituximab or cyclophosphamide, and may be used with a tapering course of corticosteroids. Patients should be monitored for infections, liver function, and blood counts. The medication should not be used in patients with known hypersensitivity to the active substance.

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