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Frequently Asked Questions

Questions About Esbriet® (pirfenidone)

See answers to some commonly asked questions about Esbriet

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

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

No, Esbriet is not approved to treat other ILDs. Esbriet is specifically studied and approved for use in IPF, which is a certain type of ILD. IPF is different from other ILDs, or diseases that cause inflammation and scarring of the lungs.

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. This treatment may also cause side effects.

Learn more about the side effects >

In a 1-year clinical study, people who took Esbriet had better breathing capacity compared with those who did not take Esbriet (193 mL difference in forced vital capacity [FVC]). Patients taking Esbriet had an average decline of 235 mL in FVC compared with a 428 mL decline for patients who did not take Esbriet.

One 72-week study showed similar results. Another 72-week study did not show a significant difference between people who took Esbriet and those who did not.

Learn more about the results of the Esbriet studies >

At the end of a 1-year clinical study of people with IPF, more than twice as many people who took Esbriet preserved baseline lung function compared to those who did not take Esbriet.

  • With Esbriet, 23% of people had stable lung function
  • Without Esbriet, 10% of people had stable lung function
  • One 72-week study showed similar results. Another 72-week study did not show a significant difference between people who took Esbriet and those who did not

Talk to your doctor about IPF treatment with Esbriet and if it may be right for you.

There may be options to help you afford your Genentech medicine, no matter what type of health insurance you have.

If you have commercial health insurance and meet other eligibility criteria, the Esbriet Co-pay Program may be able to help you pay for your medicine.*

If you have public or commercial health insurance, you may be able to get help from an independent co-pay assistance foundation.†

If you don’t have health insurance coverage or have financial concerns and meet eligibility criteria, you may be able to get free medicine from the Genentech Patient Foundation.‡

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their Genentech medicine. Patients must be taking the Genentech medicine for an FDA-approved indication. Please visit the Co-pay Program website for the full list of Terms and Conditions.

†Independent co-pay assistance foundations have their own rules for eligibility. Genentech has no involvement or influence in independent foundation decision-making or eligibility criteria and does not know if a foundation will be able to help you. We can only refer you to a foundation that supports your disease state. Genentech does not endorse or show preference for any particular foundation. The foundations we refer you to may not be the only ones that might be able to help you.

‡If you have health insurance, you should try to get other types of financial assistance, if available. You also need to meet income requirements. If you do not have insurance, or if your insurance does not cover your Genentech medicine, you must meet a different set of income requirements. Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.
Learn about financial support >

Some people may have serious side effects when taking Esbriet, including liver problems, sensitivity to sunlight (including sunlamps), severe skin reactions or stomach problems.

Other reported side effects that occurred in 10% or more of people treated with Esbriet in clinical studies 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

These are not all of the side effects reported with Esbriet. For more information, ask your doctor or pharmacist. See Managing Side Effects to learn more about possible side effects of Esbriet.

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.

In the 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)
  • 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. 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)

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

Managing Esbriet Side Effects

See How to Take Esbriet to learn about the dosing schedule and starting treatment.

Esbriet dosing is intended to allow your body to gradually adjust to the medicine.

You should always take Esbriet with food. Doing so may help reduce certain side effects, including dizziness or nausea. Taking Esbriet with food decreases how quickly Esbriet is absorbed. It also decreases the drug level of Esbriet in the blood.

IPF is progressive, and once damage occurs, it cannot be undone. It is also unpredictable: there is no way to know when your IPF will begin to get worse. Since IPF is progressive, irreversible, and unpredictable, it is important to talk to your doctor about IPF treatment today. There is no way to undo the damage caused by IPF. However, Esbriet may help preserve more lung function by slowing disease progression. Talk to your doctor about Esbriet.

Esbriet may cause serious side effects, including liver problems, sun sensitivity, severe skin reactions and stomach problems. Use the tips below to help manage and prevent certain side effects, or 

Read more about managing side effects >

Preventing sun sensitivity

  • Always use a broad-spectrum (UVA/UVB) sunscreen with SPF 50 or higher when outside. Reapply often throughout the day
  • Avoid taking other medicines that can make your skin sensitive to the sun, the light from sunlamps, and tanning beds
  • Minimize exposure to sunlight. Wear a hat and clothing that protect your skin, including your face, arms, and legs

Managing nausea and dizziness

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

Learn more about how to take Esbriet >

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.

Learn more about managing side effects >

It is important to do everything you can to preserve more lung function by slowing disease progression because there is no way to restore lost lung function.

Learn more about why lung function matters >

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.

Only you and your doctor can decide if Esbriet is right for you. If you have been diagnosed with IPF, talk to your doctor about starting Esbriet.

The FDA approved Esbriet for the treatment of IPF in October 2014.

Legacy Pharma Inc. SEZC does not have an clinical trials for new medications. The best source for information regarding clinical trials is your pulmonologist. They may be able to direct you to study centers. You can look up clinical trials on PulmonaryFibrosisFoundation.org or clinicaltrials.gov

After you and your doctor decide you should move to the brown tablets, your doctor will write a new prescription. Expect and answer phone calls from your specialty pharmacy to schedule your shipment.

Remember: Talk to your specialty pharmacy about when to fill your new prescription.

Yes. Talk with your doctor if you would like to change your Esbriet prescription.

Take Esbriet as your doctor prescribes. There are no studies showing how effective Esbriet is if someone chews or crushes it.

More than 50,000 patients have taken Esbriet.

Learn About Financial Support

Find out if you qualify for additional resources to help pay for your Esbriet treatment.

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NEXT: Tips & helpful links

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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    • Genentech’s educators are called Clinical Education Managers. They do not provide medical advice. If you have questions about your health or treatment, you are encouraged to contact your health care provider.

      Genentech’s educators are called Clinical Education Managers. They do not provide medical advice. If you have questions about your health or treatment, you are encouraged to contact your health care provider.

    • Zitter Health Insights. Policy & Access Tracking Tool for Idiopathic Pulmonary Fibrosis. Published September 2017.

      Zitter Health Insights. Policy & Access Tracking Tool for Idiopathic Pulmonary Fibrosis. Published September 2017.

    • Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. We do not endorse or show financial preference for any particular foundation. The foundations we refer you to are not the only ones that might be able to help you.

      Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. We do not endorse or show financial preference for any particular foundation. The foundations we refer you to are not the only ones that might be able to help you.

    • The Medicare Extra Help program is not a Genentech program. It is administered by the Social Security Administration. The co-pay amount for Medicare Extra Help changes each year.

      The Medicare Extra Help program is not a Genentech program. It is administered by the Social Security Administration. The co-pay amount for Medicare Extra Help changes each year.

    • This Esbriet $5 Co-pay Program is valid ONLY for patients with commercial insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid or any other federal or state government program to pay for their medications are not eligible.

      Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all out-of-pocket expenses.

      All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this Program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply. Please visit EsbrietCopay.com for the full list of Terms and Conditions.

      This Esbriet $5 Co-pay Program is valid ONLY for patients with commercial insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid or any other federal or state government program to pay for their medications are not eligible.

      Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all out-of-pocket expenses.

      All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this Program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply. Please visit EsbrietCopay.com for the full list of Terms and Conditions.

    • To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have exhausted all other forms of patient assistance (including the Esbriet $5 Co-pay Program and support from independent co-pay assistance foundations) and must meet certain financial criteria. Uninsured patients and insured patients without coverage for their medicine must meet different financial criteria.

      To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have exhausted all other forms of patient assistance (including the Esbriet $5 Co-pay Program and support from independent co-pay assistance foundations) and must meet certain financial criteria. Uninsured patients and insured patients without coverage for their medicine must meet different financial criteria.

    • Eligible patients will pay as little as $5 per valid prescription, subject to a maximum benefit of $25,000 for a 12-month period.

      Eligible patients will pay as little as $5 per valid prescription, subject to a maximum benefit of $25,000 for a 12-month period.