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ESBRIET- pirfenidone capsule


Patient Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Liver Enzyme Elevations

Advise patients that they may be required to undergo liver function testing periodically. Instruct patients to immediately report any symptoms of a liver problem (e.g., skin or the white of eyes turn yellow, urine turns dark or brown [tea colored], pain on the right side of stomach, bleed or bruise more easily than normal, lethargy)[see Warnings and Precautions (5.1)].

Photosensitivity Reaction or Rash

Advise patients to avoid or minimize exposure to sunlight (including sunlamps) during use of ESBRIET because of concern for photosensitivity reactions or rash. Instruct patients to use a sunblock and to wear clothing that protects against sun exposure. Instruct patients to report symptoms of photosensitivity reaction or rash to their physician. Temporary dosage reductions or discontinuations may be required[see Warnings and Precautions (5.2)].

Gastrointestinal Events

Instruct patients to report symptoms of persistent gastrointestinal effects including nausea, diarrhea, dyspepsia, vomiting, gastro-esophageal reflux disease, and abdominal pain. Temporary dosage reductions or discontinuations may be required[see Warnings and Precautions (5.3)].

Smokers

Encourage patients to stop smoking prior to treatment with ESBRIET and to avoid smoking when using ESBRIET[see Clinical Pharmacology (12.3)].

Take with Food

Instruct patients to take ESBRIET with food to help decrease nausea and dizziness.



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