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 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.
• severe skin reactions. Call your doctor right away if you have a severe skin reaction such as skin blisters, rash, sores in the mouth, hives or any other severe skin symptoms.
• 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 at esbriet.com.