Pirfenidone

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

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

Take with food. Recommended dosage: 801 mg three times daily (2403 mg/day). Upon initiation of treatment, titrate to the full dosage of 2403 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 (1602 mg/day) Days 15 onward 801 mg three times daily (2403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. Prior to treatment, conduct liver function tests.

None. None

Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with ESBRIET including cases of drug-induced liver injury. In the postmarketing 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. Photosensitivity and rash: Photosensitivity and rash have been noted with ESBRIET. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. 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 ESBRIET in the postmarketing setting.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury Photosensitivity Reaction or Rash Severe Cutaneous Adverse Reactions Gastrointestinal Disorders 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.

Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of ESBRIET and may alter the adverse reaction profile of ESBRIET. Discontinue fluvoxamine prior to administration of ESBRIET or reduce to 267 mg three times a day. Consider dosage reduction with use of ciprofloxacin.

Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).