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Important Safety Information

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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    • 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.