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Managing Certain Esbriet® (pirfenidone) Side Effects

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Potential Serious Side Effects
Managing Side Effects
Common Side Effects

Some People May Experience Side Effects When Taking Esbriet

Whether you are starting a new medicine or have been taking it for a period of time, it is important to know about possible side effects. Some people may experience side effects when taking Esbriet. Here are some of the serious side effects experienced by people in clinical studies of Esbriet. Be sure to discuss any side effects and how to help manage them with your doctor.

Potential Serious Side Effects

Call your doctor immediately if you experience any of these serious side effects:

  • Liver problems
    • your skin or the white part of your eyes turns yellow
    • you have dark or brown (tea-colored) urine
    • you feel pain in the upper right side of your stomach area
    • you bleed or bruise more easily than normal
    • you feel tired

Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet.

  • Sensitivity to sunlight and skin rash
    Esbriet can cause your skin to sunburn more easily
  • Severe skin reactions
    Esbriet can cause severe skin reaction such as skin blisters, rash, sores in the mouth, hives or other severe skin symptoms
  • Stomach problems
    Esbriet may cause nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain

Managing Certain Side Effects

Preventing sun sensitivities

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Always use a broad-spectrum (UVA/UVB) sunscreen with SPF 50 or higher when you are outside. Reapply often throughout the day.

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Avoid taking other medicines that can make your skin sensitive to the sun, the light from sunlamps, and tanning beds.

Esbriet Managing Side Effects Sunscreen Icon

Minimize exposure to sunlight. Wear a hat and clothing that protect your skin, including your face, arms, and legs.

Managing nausea and dizziness

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Always take Esbriet with food, as doing so may reduce side effects such as nausea and dizziness.

Some side effects may decrease

In clinical studies of Esbriet, some side effects occurred soon after starting treatment and/or decreased over time:

  • Sensitivity to sunlight. The majority of these reactions in clinical studies happened in the first 6 months on treatment. 9% of patients treated with Esbriet experienced sun sensitivity (vs 1% not taking Esbriet)
  • Stomach problems. These were most often experienced early in the course of treatment—mostly in the first 3 months—and decreased over time. 2.2% of patients had to stop taking Esbriet because of stomach problems (vs 1% not taking Esbriet)
Managing Esbriet Side Effects

These are not the only side effects. Be sure to talk to your doctor immediately if you experience any side effects.

Common Side Effects

In clinical studies, side effects that occurred in 10% or more of people treated with Esbriet included:

  • Nausea
  • Rash
  • Stomach pain
  • Upper respiratory tract infection
  • Diarrhea
  • Fatigue
  • Headache
  • Indigestion 
  • Dizziness
  • Vomiting
  • Decreased or loss of appetite 
  • Gastroesophageal reflux disease (GERD)
  • Sinusitis
  • Sleeplessness
  • Weight loss
  • Joint pain

Tell your doctor immediately if you have any side effects while you are taking Esbriet. He or she may need to reduce your dose of Esbriet or ask you to stop taking it for a short time to help manage side effects.

  • If you stop taking Esbriet for 14 or more days to help manage side effects
    • You will need to restart treatment with a low dose
    • Then slowly increase to the maximum dose
  • Your doctor may also ask you to permanently stop taking Esbriet
NEXT: Important Safety Information

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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