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

Supporting Information

Select Important Safety Information

Before you take Esbriet, tell your doctor about all of your medical conditions, including if you:

• have liver problems.
• have kidney problems.
• are a smoker.
• 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?

• 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 or a rash.
• Taking Esbriet with other medicines that can make your skin sensitive to the sun, the light from sunlamps and tanning beds.
• 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, insomnia, upper respiratory tract infections, sinusitis, headache, dizziness, decreased weight and decreased or loss of appetite.

These are not all the 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.

Please see full Prescribing Information, including Patient Information, for additional important safety information at esbriet.com.