Avacopan
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Overview
Avacopan is a complement 5a receptor antagonist that is FDA approved for the treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids. Common adverse reactions include hypertension, blood creatinine increase, fatigue, upper abdominal pain, nausea, headache, vomiting, rash, dizziness, and paresthesia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Three 10 mg capsules (30 mg) taken with food orally, twice daily.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Avacopan in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Avacopan in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Avacopan FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Avacopan in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Avacopan in pediatric patients.
Contraindications
- In patients with serious hypersensitivity when taking Avacopan.
- In patients with serious hypersensitivity when taking any of the excipients.
Warnings
Hepatotoxicity
- Higher incidences of hepatobiliary and transaminase elevations were found in controlled studies of patients taking Avacopan.
- Patients before starting Avacopan treatment, every 4 weeks after start of Avacopan, and for the first 6 months of taking Avacopan as clinically indicated thereafter should take liver test panels.
- Consult medical consultation and promptly pause use of Avacopan in patients who have an elevation in ALT or AST to >3 times the upper limit of normal.
- Discontinue the use of Avacopan until Avacopan-induced liver injury is ruled out in patients who have transaminases >3 times the upper limit of normal with elevation of bilirubin to >2 times the upper limit of normal or AST or ALT is >5 times the upper limit of normal.
- Patients should be advised to not take Avacopan with active, untreated and/or uncontrolled chronic liver disease.
Hypersensitivity Reactions
- Two cases of Aangioedema occurred in clinical studies of patients taking Avacopan with one of the cases requiring the hospitalization of a patient.
- Discontinue the use of Avacopan in patients with Aangioedema.
- Monitor patients airways and provide appropriate treatment in patients taking Avacopan who experience Aangioedema.
- Advise patients about the possible symptoms of a hypersensitivity reaction and immediatly seek medical attention if symptoms of hypersensitivity arise.
Hepatitis B Virus (HBV) Reactivation
- Clincal studies show signs of Hepatitis B virus (HBV) reactivation when taking Avacopan.
- HBV reactivation is defined as an abrupt increase in HBV replication, manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg, in a person who was previously HBsAg negative and anti-HBc positive.
- Before starting Avacopan treatment, measure HBsAg and anti-HBc in patients.
- Consider HBV antiviral therapy for patients who show signs of prior hepatitis B infection before, during, or after Avacopan treatment.
- Patients that show any evidence of current and prior history of HBV infection or HBV reactivation should be monitored during and 6 months after Avacopan treatment.
- Discontinue use of Avacopan and all concomitant drugs asscociated with HBV reactivation in patients who develop signs of reactivation of HBV.
Serious Infections
- Fatal infections such as pneumonia and urinary tract infections were found in patients taking Avacopan.
- Patients with active, serious infections should be advised not to take Avacopan.
- Patients who have been exposed to tuberculosis, have underlying conditions that may predispose them to infection, have chronic or recurrent infection, have a history of a serious or an opportunistic infection, or have resided or traveled in areas of endemic tuberculosis or endemic mycoses should be advised of the risks and benefits of taking Avacopan.
- Signs of infection during or after treatment with Avacopan should be monitored.
- Avacopan treatment should be interrupted if signs of serious or opportunistic infection develop.
- Diagnostic tests should be advised in patients who develop new infections when taking Avacopan.
- Avacopan treatment can be resumed when infection is under control.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Avacopan Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Avacopan Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Avacopan Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Avacopan in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Avacopan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Avacopan during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Avacopan in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Avacopan in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Avacopan in geriatric settings.
Gender
There is no FDA guidance on the use of Avacopan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Avacopan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Avacopan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Avacopan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Avacopan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Avacopan in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Avacopan Administration in the drug label.
Monitoring
There is limited information regarding Avacopan Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Avacopan and IV administrations.
Overdosage
There is limited information regarding Avacopan overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Avacopan Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Avacopan Mechanism of Action in the drug label.
Structure
There is limited information regarding Avacopan Structure in the drug label.
Pharmacodynamics
There is limited information regarding Avacopan Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Avacopan Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Avacopan Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Avacopan Clinical Studies in the drug label.
How Supplied
There is limited information regarding Avacopan How Supplied in the drug label.
Storage
There is limited information regarding Avacopan Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Avacopan Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Avacopan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Avacopan Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Avacopan Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.