Pirfenidone
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Pirfenidone is a respiratory agent that is FDA approved for the treatment of idiopathic pulmonary fibrosis (IPF). Common adverse reactions include nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
- Dosage:
- 267 mg (1 capsule) ORALLY 3 times daily for 7 days
- Then 534 mg (2 capsules) ORALLY 3 times daily on days 8 through 14
- Then 801 mg (3 capsules) ORALLY 3 times daily thereafter
- All doses should be taken with food
- Doses greater than 2403 mg/day not recommended
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pirfenidone in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pirfenidone in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pirfenidone 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 Pirfenidone in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pirfenidone in pediatric patients.
Contraindications
None
Warnings
There is limited information regarding Pirfenidone Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Pirfenidone Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Pirfenidone Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Pirfenidone Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Pirfenidone in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pirfenidone in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pirfenidone during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pirfenidone in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pirfenidone in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pirfenidone in geriatric settings.
Gender
There is no FDA guidance on the use of Pirfenidone with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pirfenidone with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pirfenidone in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pirfenidone in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pirfenidone in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pirfenidone in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pirfenidone Administration in the drug label.
Monitoring
There is limited information regarding Pirfenidone Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pirfenidone and IV administrations.
Overdosage
There is limited information regarding Pirfenidone 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 Pirfenidone Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pirfenidone Mechanism of Action in the drug label.
Structure
There is limited information regarding Pirfenidone Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pirfenidone Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pirfenidone Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pirfenidone Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pirfenidone Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pirfenidone How Supplied in the drug label.
Storage
There is limited information regarding Pirfenidone 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 Pirfenidone Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pirfenidone 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 Pirfenidone Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Pirfenidone 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.