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PIRFENIDONE

PIRFENIDONE

Manufacturer: MAJOR PHARMACEUTICALS

Score: 141.0

Quick Summary

Pirfenidone is a medication used for the treatment of idiopathic pulmonary fibrosis (IPF). The recommended dosage is 801 mg three times daily, with a titration period of 14 days. Key clinical findings indicate that pirfenidone can reduce the decline in forced vital capacity (FVC) and improve progression-free survival. Important safety information includes warnings about liver enzyme elevations, photosensitivity reactions, and severe cutaneous adverse reactions. Contraindications are not listed, but caution is advised when using pirfenidone with CYP1A2 inhibitors. Dose adjustments may be necessary in patients with liver or renal impairment. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with no established safety and efficacy in pediatric patients and no requirement for dose adjustment based on age.

Key Clinical Findings and Indications

  • Treatment of idiopathic pulmonary fibrosis (IPF)
  • Reduces decline in forced vital capacity (FVC)
  • Improves progression-free survival

Important Safety Information

Warning

Liver enzyme elevations, photosensitivity reactions, and severe cutaneous adverse reactions

Contraindications

Adverse Reactions

  • Nausea
  • Rash
  • Abdominal pain
  • Upper respiratory tract infection
  • Diarrhea
  • Fatigue
  • Headache
  • Decreased appetite
  • Dyspepsia
  • Dizziness
  • Vomiting
  • Gastro-esophageal reflux disease
  • Sinusitis
  • Insomnia
  • Weight decreased
  • Arthralgia

Dosing Recommendations

General Guidance

May be necessary in patients with liver or renal impairment, or when using CYP1A2 inhibitors

IPF

Adult Dose

801 mg three times daily, with a titration period of 14 days

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Insufficient data to inform on drug-associated risks for major birth defects and miscarriage

Nursing Mothers

Pediatric Use

  • Safety and effectiveness not established

Geriatric Use

  • No overall differences in safety or effectiveness observed between older and younger patients
  • No dose adjustment required based on age