Esbriet®

Esbriet® (pirfenidone) is a prescription medicine used to treat people with idiopathic pulmonary fibrosis (IPF). It is not known if Esbriet is safe and effective in children.

Preserving your lung function

Although lung function that is lost cannot be restored, treatment may help maintain more lung function by slowing disease progression.

• In a 1-year clinical study, people taking Esbriet had better breathing capacity than people who did not take Esbriet (193 mL difference in forced vital capacity).
• 23% of people taking Esbriet had stable lung function compared with 10% of people who did not take Esbriet at 1 year.
• One 72-week study showed similar results; another 72-week study did not show a significant difference.

• IPF is progressive: scarring and loss of lung function continue over time.
• IPF is unpredictable: progression differs from person to person.
• IPF is irreversible: existing lung scarring cannot be reversed, but treatment options may slow progression.

Key facts

• Esbriet was FDA approved based on 3 clinical studies evaluating safety and effectiveness.
• Esbriet may help preserve lung function for some people with IPF.
• Esbriet may cause serious side effects.
• Once treatment begins, you may not feel different because Esbriet does not treat IPF symptoms or reverse existing scarring.

Before starting Esbriet, your doctor should perform blood tests to check liver function. The dose is increased gradually over 2 weeks until the full daily dose is reached.

• For 267 mg capsules or tablets, the recommended full daily dose is 3 pills taken 3 times each day with food.
• Take doses at the same times each day: morning, afternoon and evening.
• If you miss a dose, take it with food as soon as you remember. Do not take 2 doses at the same time or more than 3 doses in one day.
• If you take too much Esbriet, call your doctor or go to the nearest emergency room.
• Taking Esbriet with food may help reduce dizziness or nausea.

Fewer-pills option

The full maintenance dose is 801 mg 3 times daily with food (2,403 mg/day). This can be taken as three 267 mg capsules/tablets per dose or, when prescribed, one 801 mg tablet per dose, taken 3 times daily with food.

Tell your doctor before taking Esbriet if you have liver or kidney problems, smoke, are pregnant or planning pregnancy, are breastfeeding, or take prescription medicines, over-the-counter medicines, vitamins or herbal supplements.

Potential serious side effects

• Liver problems: symptoms can include yellow skin or eyes, dark or brown urine, upper-right abdominal pain, easier bleeding or bruising, or increased fatigue.
• Sensitivity to sunlight and skin rash. Use sunscreen (SPF 50), a hat and protective clothing outdoors.
• Stomach problems including nausea, vomiting, diarrhea, indigestion, heartburn and stomach pain.

Common side effects reported in clinical studies included nausea, rash, stomach pain, upper respiratory tract infection, diarrhea, fatigue, headache, indigestion, dizziness, vomiting, decreased appetite, GERD, sinusitis, sleeplessness, weight loss and joint pain.

If Esbriet is stopped for 14 days or more, treatment must be restarted at a low dose and gradually increased. Follow your doctor’s instructions.

Call your doctor for medical advice about side effects. Side effects may be reported to the FDA at 1-800-FDA-1088 or FDA MedWatch, or to Genentech at 1-888-835-2555.

Genentech Access Solutions can help you understand insurance coverage and possible out-of-pocket costs and can refer you to Genentech co-pay programs, independent co-pay assistance foundations, or the Genentech Patient Foundation.

The Esbriet® Inspiration Program™ offers educational support about treatment, financial assistance options, living with IPF and taking Esbriet. Genentech Clinical Coordinators do not provide medical advice.

Esbriet patient support and resources

Esbriet resources include recipe cards with quick meal ideas and a Tracking Your Journey Journal designed to help patients and their doctors record treatment, activities and life events.

Full Prescribing Information