Questions about Esbriet
See answers to some commonly asked questions 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.
Lost lung function cannot be restored. However, Esbriet may help preserve more of your lung function by slowing the progression of the disease.
At the end of a 1-year clinical study of people with IPF, more people who took Esbriet had stable lung function, compared with people 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 trial showed similar results. Another 72-week trial did not show a significant difference between patients 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.
The recommended maximum daily dose of Esbriet is 3 pills taken 3 times each day with a meal. The table below shows the recommended Esbriet dosing schedule. It lists the amount of pills to take at each mealtime, over the first 3 weeks of treatment.
Your doctor may change the amount of Esbriet you should take in order to help manage side effects. Always take Esbriet as prescribed by your doctor.
See How to Take Esbriet to learn more about dosing information, including how your doctor will increase your dose in the first 3 weeks, and information about taking Esbriet with a meal.
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.
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 slow disease progression. Talk to your doctor about Esbriet.
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:
- stomach pain
- upper respiratory tract infection
- decreased or loss of appetite
- gastroesophageal reflux disease (GERD)
- 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. You may also report side effects to Genentech at 1-888-835-2555.
In clinical studies with 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.
- Stomach problems: These were most often experienced early in the course of treatment—mostly in the first 3 months—and decreased over time
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. You should also wear a hat and other clothing that protects your skin, including your face, arms, and legs.
Managing nausea and dizziness: Taking Esbriet with a meal may reduce side effects such as nausea and dizziness. Your doctor may also suggest that you take each of the 3 capsules separately throughout a meal or after a meal.
If you experience side effects, talk with your doctor. 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.
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 as prescribed by your doctor may help preserve more of your lung function by slowing IPF progression.
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.