FDA Approves Medicine for Idiopathic Pulmonary Fibrosis
October 15th, 2014
On October 15, 2014, the FDA approved Esbriet®(pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
News in brief
- Approximately 100,000 people in the United States have IPF, an irreversible and fatal lung disease
- Esbriet was approved under FDA’s Breakthrough Designation program
- Expected availability in the US within two weeks
Select Important Safety Information
What should I tell my doctor before taking Esbriet?
Before you take Esbriet, tell your doctor if you:
- have liver problems
- have kidney problems
- are a smoker
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if Esbriet will harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while taking Esbriet?
- Avoid sunlight. Esbriet can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn
- Avoid smoking. Smoking may affect how well Esbriet works
What are the possible side effects of Esbriet?
Esbriet may cause serious side effects, including:
- liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, or feeling tired.
Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet
- sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking Esbriet?”
- stomach problems. Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of Esbriet
The most common side effects of Esbriet include feeling tired, headache, dizziness, and decreased or loss of appetite.
These are not all the possible side effects of Esbriet. For more information, ask your doctor or pharmacist.
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.
Please see full Prescribing Information, including Patient Information, at www.Esbriet.com for additional important safety information.
“This is a historic day for the people and their families in the United States who live with this deadly, incurable disease. With today’s approval of Esbriet in the United States, people with IPF finally have an FDA-approved medicine that may slow the worsening of the disease.”