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How Esbriet® (pirfenidone) May Help Slow IPF

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Preserving Your Lung Function
Important Things To Keep in Mind With IPF Treatment

Preserving Your Lung Function Is Essential and Esbriet May Help

Esbriet may help preserve more of your lung function by slowing disease progression

Esbriet is a prescription medicine for the treatment of IPF. IPF is different from other interstitial lung diseases (ILD), or diseases that cause inflammation and scarring of the lungs. Esbriet is specifically studied and approved for use in IPF, which is a certain type of ILD.

Although lung function that is lost cannot be restored, treatment may help maintain more of your lung function by slowing the progression of the disease.

Less decline in FVC volume for people taking Esbriet

  • In a 1-year clinical study, people who took Esbriet had better breathing capacity compared to those who did not take Esbriet (193 mL difference in forced vital capacity)
  • More than twice as many people who took Esbriet had stable lung function (23%) compared to those who did not take Esbriet (10%) at 1 year
  • One 72-week study showed a similar result
  • Another 72-week study did not show a significant difference between people who took Esbriet and those who did not

How lung function was measured

In the clinical studies, the effect of Esbriet on lung function (how well the lungs work) was measured by forced vital capacity (FVC). FVC measures the amount of air you can exhale with force after you inhale as deeply as possible.

Key facts about Esbriet
  • Esbriet was Food and Drug Administration approved based on 3 clinical studies that evaluated its safety and how well it worked in more than 1,400 patients
    • More than 170 of these patients were treated with Esbriet for over 5 years in clinical studies
  • Esbriet is proven to help preserve lung function for some people with IPF
  • Esbriet may cause serious side effects

Important Things To Keep in Mind With IPF Treatment

  • IPF is progressive, so slowing its decline can be an important goal of treatment

  • Starting and staying on Esbriet treatment as prescribed by your doctor can be an important way to help preserve more of the lung function you have today by slowing disease progression

  • Esbriet has been shown to preserve lung function. Therefore, once you begin taking Esbriet, you may not “feel” different because Esbriet does not treat the symptoms of IPF and does not reverse the scarring in your lungs

  • IPF worsens at different rates in different people. With or without Esbriet, lung function may continue to decline. Remember, the goal is to slow the decline. Your doctor will conduct lung function tests to measure how IPF is affecting your lungs over time
NEXT: Esbriet side effects

Select Important Safety Information and Indication

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 Legacy Pharma Inc. SEZC at 1-800-727-7151.

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

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