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Prescribing Information

Healthcare Professionals Site

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 * Home
 * About Idiopathic Pulmonary Fibrosis (IPF)
    * What Is Idiopathic Pulmonary Fibrosis (IPF)?
    * How Does Idiopathic Pulmonary Fibrosis (IPF) Affect Me?

 * About Esbriet
    * How Esbriet May Help

 * Side Effects
    * Esbriet Side Effects
    * Safety

 * Results With Esbriet
    * Patient Stories

 * Taking Esbriet
    * How To Take Esbriet
    * Building a Routine

 * FAQs & Resources
    * FAQs
    * Tips & Helpful Links
    * Questions To Ask Your Doctor
    * Glossary

 * Financial Support
    * Financial Assistance Options

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SELECT IMPORTANT SAFETY INFORMATION AND INDICATION

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ABOUT ESBRIET

Esbriet® (pirfenidone) is a prescription medicine used to treat people with a
lung disease called idiopathic pulmonary fibrosis (IPF).

It is not known if Esbriet is safe and effective in children.

BEFORE YOU TAKE ESBRIET, TELL YOUR DOCTOR IF YOU:

 * have other medical conditions (particularly liver or kidney problems).
 * are a smoker.
 * are or plan to become pregnant or breastfeed (Esbriet has not been studied in
   these patients).
 * are taking any prescription or over-the-counter medicines, vitamins, or
   herbal supplements.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ESBRIET?

Esbriet may cause serious side effects, including:

 * liver problems. Call your doctor if you have symptoms such as yellowing of
   your skin or eyes, dark or brown urine, pain on the upper right side of your
   stomach area, bleeding or bruising more easily than normal, or increased
   fatigue. Your doctor will also do regular blood tests to check your liver.
 * sun sensitivity and rash. When you are outside, use sunscreen (SPF 50) and
   wear a hat and clothes that cover your skin to avoid getting a sunburn.
 * severe skin reactions. Call your doctor right away if you have a severe skin
   reaction such as skin blisters, rash, sores in the mouth, hives or any other
   severe skin symptoms.
   
 * stomach problems. Esbriet may cause stomach problems such as nausea,
   vomiting, diarrhea, indigestion, heartburn, and stomach pain.

Your doctor may change your dose or discontinue Esbriet if side effects do not
go away.

The most common side effects of Esbriet include upper respiratory tract
infections, feeling tired, headache, dizziness, loss of appetite, sinusitis,
insomnia, or weight loss.

These are not all the possible side effects of Esbriet.

WHAT SHOULD YOU AVOID WHILE TAKING ESBRIET?

 * Direct exposure to sunlight, or light from sunlamps and tanning beds.
 * Other medicines that can make your skin sensitive to sunlight.
 * Smoking, which may affect how well Esbriet works.

Call your doctor for medical advice about side effects. You may report side
effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at
1-888-835-2555.

Please see full Prescribing Information, including Patient Information, for
additional important safety information.


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