pharmacopeia
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/api/v1/drug/pirfenidone

Mechanism of action

Sourced from openFDA

The mechanism of action of pirfenidone in the treatment of IPF has not been established.

Indications

Sourced from openFDA
  • Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

Take with food. Recommended dosage: 801 mg three times daily (2,403 mg/day). (2) Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1,602 mg/day) Days 15 onward 801 mg three times daily (2,403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. ( 2.3 , 5.1 , 5.2 , 5.3 , 5.4 ) Prior to treatment, conduct liver function tests. ( 2.1 ) 2.1 Testing Prior to Pirfenidone Capsules Administration Conduct liver function tests prior to initiating treatment with pirfenidone capsules [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage The recommended daily maintenance dosage of pirfenidone capsule is 801 mg three times daily for a total of 2,403 mg/day. Doses should be taken with food at the same time each day. Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Table 1: Dosage Titration for Pirfenidone Capsules in Patients with IPF Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1,602 mg/day) Days 15 onward 801 mg three times daily (2,403 mg/day) Dosages above 2,403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

Warnings & precautions

Sourced from openFDA

Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury. In the post-marketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required. ( 2.1 , 5.1 ) Photosensitivity and rash: Photosensitivity and rash have been noted with pirfenidone. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required. ( 5.2 ) Severe Cutaneous Adverse Reactions (SCAR): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reactions with eosinophilia and systemic symptoms (DRESS) have been reported in association with the use of pirfenidone in the post-marketing setting. Interrupt pirfenidone in case of signs or symptoms of SCAR. Permanently discontinue pirfenidone if a SCAR is confirmed. ( 5.3 ) Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastro-esophageal reflux disease, and abdominal pain have occurred with pirfenidone. Temporary dosage reductions or discontinuations may be required. ( 5.4 ) 5.1 Elevated Liver Enzymes and Drug-Induced Liver Injury Cases of drug-induced liver injury (DILI) have been observed with pirfenidone.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions (5.1) ] Photosensitivity Reaction or Rash [see Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Gastrointestinal Disorders [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of pirfenidone has been evaluated in more than 1,400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials. Pirfenidone was studied in 3 randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3) in which a total of 623 patients received 2,403 mg/day of pirfenidone and 624 patients received placebo. Subjects ages ranged from 40 to 80 years (mean age of 67 years). Most patients were male (74%) and Caucasian (95%).

Use in specific populations

Sourced from openFDA

Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed. Pirfenidone is not recommended for use in patients with severe hepatic impairment. ( 8.6 , 12.3) Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed. Pirfenidone is not recommended for use in patients with end stage renal disease on dialysis. ( 8.7 , 12.3) Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of pirfenidone. ( 8.8 ) 8.1 Pregnancy Risk Summary The data with pirfenidone use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. In animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproductive studies were conducted in rats and rabbits.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption After single oral-dose administration of 801 mg pirfenidone (three 267 mg capsules), the maximum observed plasma concentration (C max ) was achieved between 30 minutes and 4 hours (median time of 0.5 hours). Food decreased the rate and extent of absorption.

Overdosage

Sourced from openFDA

There is limited clinical experience with overdosage. Multiple-dosages of pirfenidone up to a maximum tolerated dose of 4,005 mg per day were administered as five 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation. In the event of a suspected overdosage, appropriate supportive medical care should be provided, including monitoring of vital signs and observation of the clinical status of the patient.

Approval history

Sourced from openFDA
  • Jan 11, 2017NDANDA208780Legacy Pharma
  • Jan 3, 2022ANDAANDA212569Amneal
  • Jan 25, 2022ANDAANDA212730Accord Hlthcare
  • Jan 25, 2022ANDAANDA212759Teva Pharms Usa
  • Mar 25, 2022ANDAANDA212570Amneal
  • Apr 28, 2022ANDAANDA212560Sandoz
  • May 18, 2022ANDAANDA212680Micro Labs
  • May 20, 2022ANDAANDA212708Alembic

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
40,089 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Death7,47319%
  2. 2Nausea5,15113%
  3. 3Fatigue3,7929.5%
  4. 4Decreased Appetite3,2488.1%
  5. 5Diarrhoea3,2348.1%
  6. 6Dyspnoea2,9177.3%
  7. 7Weight Decreased2,2145.5%
  8. 8Dizziness2,1675.4%
  9. 9Rash2,0345.1%
  10. 10Cough2,0205.0%
  11. 11Vomiting1,8034.5%
  12. 12Pneumonia1,7694.4%
  13. 13Abdominal Discomfort1,6784.2%
  14. 14Abdominal Pain Upper1,5063.8%
  15. 15Headache1,4983.7%

Clinical trials

View JSON

The 10 most recently updated of 169 ClinicalTrials.gov registrations naming Pirfenidone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pirfenidone work?
The mechanism of action of pirfenidone in the treatment of IPF has not been established.
What is Pirfenidone used for?
According to FDA labeling, Pirfenidone carries indications including: Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pirfenidone?
Pirfenidone is classified as Other immunosuppressants, Pyridone, Unknown Cellular or Molecular Interaction, Decreased Growth Factor Activity.
What are the brand names for Pirfenidone?
Pirfenidone is marketed under brand names including Esbriet.
What are the contraindications for Pirfenidone?
Pirfenidone labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for pirfenidone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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