Indication

Esbriet^® (pirfenidone) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Select Important Safety Information

Elevated liver enzymes: ALT, AST, and bilirubin elevations have occurred with Esbriet. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required.

Photosensitivity reaction or rash: Photosensitivity and rash have been noted with Esbriet. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required.

Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease, and abdominal pain have occurred with Esbriet. Temporary dosage reductions or discontinuations may be required.

Adverse reactions: The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastroesophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.

Drug interactions: 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.

Specific populations:

• Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. Esbriet is not recommended for use in patients with severe hepatic impairment.
• Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. Esbriet is not recommended for use in patients with end stage renal disease on dialysis.
• Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of Esbriet.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.