Questions about Esbriet

See answers to some commonly asked questions about Esbriet

What is Esbriet^® (pirfenidone)?

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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.

How might Esbriet help me?

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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 here >

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

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).

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 here >

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

How do I take Esbriet?

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

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.

How do I move from the 3 pills (267 mg each, capsules or tablets, 3 times daily) to the 1 brown tablet (801 mg, 3 times daily)?

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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 Esbriet 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.

If I prefer to switch back to my former dosing routine of 3 pills, 3 times a day, can I?

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

How much does the 801 mg brown tablet cost?

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The brown tablet is priced the same as the 267 mg formulation. Call Esbriet Access Solutions at 1-844-372-7438 if you have questions about cost.

Can I chew or crush the brown tablet?

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

My condition is stable. Do I need to take a medication?

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There is no way to know when your IPF will begin to get worse. IPF is progressive, irreversible, and unpredictable, so 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.

Learn more about how Esbriet may help >

What are the possible side effects of Esbriet?

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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:

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 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.

Possible side effects of Esbriet that decreased over time

What can I do to manage certain side effects?

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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 here >

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 here >

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.

For more information about other side effects, see Managing Certain Side Effects >

Why is staying on Esbriet important?

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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 here >

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.

How do I know that Esbriet is right for me?

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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.

How long has Esbriet been available in the United States?

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

Call an Esbriet nurse for more information: 844-693-7274

PATIENT SUPPORT PROGRAM

Receive ongoing support and materials from the Esbriet^® Inspiration Program™ to help you manage IPF.

LEARN ABOUT FINANCIAL SUPPORT

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

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Questions about Esbriet

See answers to some commonly asked questions about Esbriet

What is Esbriet^® (pirfenidone)?

How might Esbriet help me?

How do I take Esbriet?

How do I move from the 3 pills (267 mg each, capsules or tablets, 3 times daily) to the 1 brown tablet (801 mg, 3 times daily)?

If I prefer to switch back to my former dosing routine of 3 pills, 3 times a day, can I?

How much does the 801 mg brown tablet cost?

Can I chew or crush the brown tablet?

My condition is stable. Do I need to take a medication?

What are the possible side effects of Esbriet?

What can I do to manage certain side effects?

Why is staying on Esbriet important?

How do I know that Esbriet is right for me?

How long has Esbriet been available in the United States?

PATIENT SUPPORT PROGRAM

LEARN ABOUT FINANCIAL SUPPORT

References

Select Important Safety Information and Indication

About Esbriet

Before you take Esbriet, tell your doctor if you:

What are the possible side effects of Esbriet?

What should you avoid while taking Esbriet?