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Prescribing Information

    A
    Alveoli

    Small air sacs in the lungs where oxygen moves from the lungs into the blood.

    C
    Clinical study

    An experiment done with human participants to test the safety and efficacy of treatment interventions, such as medicines or devices. Also called a clinical trial.

    D
    DLCO test

    Short for "carbon monoxide diffusing capacity test." A test that uses carbon monoxide to measure how well it can move between the lungs and the blood.

    Disease Progression

    Disease progression refers to how a disease progresses, or gets worse. Because IPF is a progressive disease, it will continue to get worse over time.

    F
    Fibrosis

    The formation of scar tissue.

    Forced expiratory volume in one second (FEV1)

    The amount of air you can exhale in one second with force.

    Forced vital capacity (FVC)

    The amount of air you can exhale with force after you inhale as deeply as possible.

    H
    HRCT scan

    High-resolution computed tomography scan. A type of scan that makes detailed images of parts of the body, such as the lungs.

    I
    IPF

    A disease that leaves permanent scarring in the lungs. The cause is unknown.

    L
    Lung function

    How well the lungs work.

    O
    Organ

    A part of the body that is self contained and has a specific vital function. One example of an organ is the heart.

    Oxygen saturation

    A measurement of how much oxygen is in the blood.

    P
    Pulmonary function tests

    Tests that measure how well the lungs work.

    Pulmonologist

    A doctor who specializes in lungs and diseases of the lung.

    S
    Spirometry

    A type of test that measures how much air moves in and out of the lungs.

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.
  • 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.

    • Centers for Medicare & Medicaid Services. Advance notice of methodological changes for calendar year (CY) 2018 for Medicare Advantage (MA) capitation rates, Part C and Part D payment policies and 2018 call letter. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2018.pdf. Posted February 1, 2017. Accessed October 17, 2017.

      Centers for Medicare & Medicaid Services. Advance notice of methodological changes for calendar year (CY) 2018 for Medicare Advantage (MA) capitation rates, Part C and Part D payment policies and 2018 call letter. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2018.pdf. Posted February 1, 2017. Accessed October 17, 2017.