Esbriet

Esbriet ((pirfenidone) may be used to treat adults with idiopathic pulmonary fibrosis (IPF), a lung condition that causes inflammation and scarring in the lungs.

Esbriet’s mechanism of action involves slowing down the build-up of scar tissue in the lungs. The exact way it works for IPF is not known, but it does have anti-inflammatory, antioxidant, and anti-fibrotic properties. Esbriet is not a cure for IPF, but it does slow how quickly the condition progresses. Clinical studies have reported that Esbriet may prolong overall survival in patients with IPF by 2.5 to 5 years (see Does Esbriet improve survival?).

Esbriet gained FDA approval on October 15, 2014. An Esbriet generic is available under the name pirfenidone.

Esbriet is available as generic pirfenidone or brand-name Esbriet.

Co-pay Program Transition: The Esbriet Co-pay Program is transferring from Genentech to Legacy on November 1, 2025.

Current Enrollees: Can use Genentech benefits through October 31, 2025. For prescriptions dated November 1, 2025, or later, contact Legacy at (877) 780-4958

New Enrollments:

• Genentech: No new enrollments after September 30, 2025
• Legacy: Contact (877) 780-4958 for enrollment starting November 1, 2025

Financial Assistance: The Genentech Patient Foundation provides free Esbriet to eligible uninsured/underinsured patients.

Questions: Call (877) 780-4958, M-F, 9 am-8 pm ET, or contact your physician about treatment.

See Esbriet Prices, Coupons, Copay Cards & Patient Assistance for the cost of Esbriet capsules and tablets.

Take Esbriet exactly as your doctor tells you to take it. Your doctor may change your dose of Esbriet as needed.

• Esbriet is usually taken three times a day.
• Take Esbriet with food at the same times each day. This may help to decrease side effects such as nausea and dizziness.
• Esbriet is usually taken long-term (see How long can you take Esbriet for?).

Your doctor should do certain blood tests before you start taking Esbriet.

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
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Esbriet will harm your unborn baby.

Breastfeeding

It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed.

The most common side effects of Esbriet are:

• feeling tired
• difficulty sleeping
• upper respiratory tract infections, such as a cold
• sinus infections
• headache
• dizziness
• weight loss
• and lower or loss of appetite.

Serious side effects and warnings

Esbriet may cause the following serious side effects.

Liver problems. High liver enzymes and liver damage have occurred in people taking Esbriet. 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, feeling tired.

Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet.

Esbriet may make your skin more sensitive to sunlight and cause a rash. See “What should I avoid while taking Esbriet?”

Esbriet has caused 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. Your doctor may stop your treatment with Esbriet.

Stomach problems, such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain have also been reported with Esbriet. 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 if you develop any of these reactions.

It is not known if Esbriet is safe or effective in children.

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.

The recommended dosage of Esbriet for adults with IPF is below. The maximum total daily dose of Esbriet is 2403 mg/day.

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 or a rash.
• Avoid taking Esbriet with other medicines that can make your skin sensitive to the sun, the light from sunlamps, and tanning beds.

Avoid smoking. Smoking may affect how well Esbriet works.

Take the missed dose as soon as you remember but if it is almost time for your next dose, miss that dose, and go back to your regular dosing schedule. Do not take 2 doses at the same time to make up for your missed dose.

If you miss 14 days or more of Esbriet call your doctor right away for further instructions about how to take your medicine.

Do not take more than 3 doses of Esbriet each day. If you take too much Esbriet, call your doctor or go to the nearest hospital emergency room right away.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Moderate (such as ciprofloxacin) and strong inhibitors of CYP1A2 (such as fluvoxamine) increase blood levels of Esbriet and may increase the risk of side effects.

• Discontinue fluvoxamine before administering Esbriet or reduce the dosage to 267 mg three times a day.
• Your healthcare provider may consider a dosage reduction with the use of ciprofloxacin.

Store Esbriet capsules and tablets at room temperature, 77°F (25°C). Keep in a tightly closed container.

Safely throw away any Esbriet that is out of date or no longer needed. Keep Esbriet and all medicines out of reach of children

Active ingredient: pirfenidone

Inactive ingredients (Esbriet capsules): microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate. Capsule Shell: gelatin and titanium dioxide. Capsule Brown Printing Ink: shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide.

Inactive ingredients (Esbriet tablets): microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.

Available as Esbriet 267 mg capsules, Esbriet 267 mg tablets, and Esbriet 801 mg tablets.

Genentech USA, Inc makes Esbriet.