QUESTIONS ABOUT ESBRIET (PIRFENIDONE)

Esbriet^® (pirfenidone) 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 ILD's. Esbriet is specifically studied and approved for use in IPF, which is a certain type of interstitial lung disease. IPF is different from other interstitial lung diseases (ILD), 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 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. 

We understand your medicine can be costly. We can help you find assistance that may help you pay for your Genentech medicine.

Genentech Access Solutions can:

• Help you understand your health insurance coverage by finding out:
  • If your health insurance covers your Genentech medicine
  • How much your co-pay will be for your medicine
• Refer you to appropriate financial assistance options:
  • Genentech co-pay programs
  • Independent co-pay assistance foundations
  • Genentech Patient Foundation

Learn more about Genentech Access Solutions >

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

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

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 Genentech at 1-888-835-2555.

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)
• 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.

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, 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.

You can schedule up to 5 free and optional one-on-one educational sessions with a Clinical Education Manager (CEM) specially trained in IPF and Esbriet to learn more about your condition and treatment.

Clinical Education Managers  offer education related to IPF and Esbriet, managing possible side effects, and support options that may be available to you.

Call 1-844-My-Esbriet (1-844-693-7274) and press 3 to schedule a session.

CEMs are Genentech employees who educate about IPF and Esbriet. They do not provide medical advice. If you have questions about your health or treatment, you are encouraged to contact your healthcare provider. 

Learn more here >

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

The best source for information regarding clinical trials is your pulmonologist. They may be able to direct you to study centers. You can also call Genentech's Clinical Trial Information Support Line at (888) 662-6728 to understand what studies Genentech has ongoing. 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 Genentech Access Solutions, a resource to help you understand if your health insurance covers Esbriet and how much your co-pay will be
• From your Specialty Pharmacy, to schedule your shipment of brown tablets

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.