Esbriet® (Pirfenidone)

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.

Preserving Your Lung Function is Essential and Esbriet May Help

Esbriet® (pirfenidone) may help preserve more of your lung function by slowing disease progression

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.

• In a 1-year clinical study, people who took Esbriet had better breathing capacity compared to those who did not take Esbriet (193 mL difference in forced vital capacity)

• More than twice as many people who took Esbriet had stable lung function (23%) compared to those who did not take Esbriet (10%) at 1 year

Why Should I Consider Treatment?

• IPF is progressive. This means that the scarring caused by IPF will continue to happen, and lung function will continue to get worse
• IPF is unpredictable. It is difficult to know how slowly or quickly IPF will progress. Each person’s experience is different
• IPF is irreversible. Once there is scarring in the lungs, it cannot be reversed. Today, there is no cure for IPF, but there are treatment options that may slow its progression

Patient Stories

Meet the Esbriet Ambassadors and Hear Their Stories

The Esbriet Ambassadors are people who are sharing their life stories and treatment experiences, helping to raise awareness and understanding about IPF and Esbriet (pirfenidone).

Key facts about Esbriet

• Esbriet was FDA approved based on 3 clinical studies that evaluated its safety and how well it worked
• Esbriet is proven to help preserve lung function for some people with IPF
• Esbriet may cause serious side effects
• Esbriet has been used in more than 42,000 patients worldwide

Important things to keep in mind with IPF treatment

• IPF is progressive, so slowing its decline can be an important goal of treatment
• 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 by slowing disease progression
• Once you begin taking Esbriet, you may not “feel” different, because Esbriet does not treat the symptoms of IPF and does not reverse the scarring in your lungs
• IPF worsens at different rates in different people. With or without Esbriet, lung function may continue to decline. Remember, the goal is to slow the decline. Your doctor will conduct lung function tests to measure how IPF is affecting your lungs over time.

Taking the Medication

Starting Esbriet

• Before you start Esbriet, your doctor should do certain blood tests to check how your liver is working
• When you start Esbriet, your doctor will slowly increase the dose over 2 weeks. This continues until you reach the full daily dose. This will allow your body time to get used to the medicine. (Increasing or decreasing the dose is called titration)
• Your doctor may adjust your dose to help alleviate side effects. It is always important to follow your doctor’s instructions

Follow the dosing schedule your doctor gave you. The table below shows the recommended Esbriet dosing schedule for the 267 mg capsules or tablets.

• The recommended full daily dose of Esbriet is 3 pills (267 mg each, yellow tablets or white capsules) taken 3 times every day with food
• There is another dosing option with fewer pills per day. To learn more, see the section below
• Doses should be taken at the same times each day with food: in the morning, afternoon, and evening
• If you miss a dose of Esbriet, take it with food as soon as you remember
• Do not take 2 doses at the same time to make up for a missed dose
• Do not take more than 3 doses in a day
• If you take too much Esbriet, call your doctor or go to the nearest hospital emergency room right away

• If you experience side effects, talk with your healthcare provider, who may need to reduce your dose or ask you to stop taking Esbriet for a short time to help reduce side effects

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.

An Option with Fewer Pills per Day

After you are doing well with the 9 pills (267 mg each, yellow tablets or white capsules) of Esbriet a day, you and your doctor may want to talk about moving to a 3 tablet per day option.

• Each brown tablet has the same amount of medicine as 3 of the 267 mg pills
• 1 brown tablet is taken 3 times a day with food
• After you are doing well on the 9 pills per day, talk with your doctor about whether the 1 brown tablet, 3 times a day, is right for you.

Once you are doing well on 9 pills a day, ask your doctor if transitioning to 3 brown tablets is an option for you.
If you have questions about your Esbriet dose, talk to your doctor.

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.
• 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.