Esbriet

Generic name: pirfenidone [ pir-FEN-i-done ]
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Sophia Entringer, PharmD. Last updated on Sep 28, 2023.

What is Esbriet?

Esbriet is used in adults to treat a lung disease called idiopathic pulmonary fibrosis (IPF).

IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen..

The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal..

Esbriet is not a cure for IPF, but this medicine may slow the progress of this disease..

Esbriet belongs to a class of medications called pyridones. Pirfenidone works by blocking the action of a certain natural substance in the body that is involved in causing fibrosis.

Esbriet side effects

Get emergency medical help if you have signs of an allergic reaction to Esbriet (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Esbriet may cause serious side effects. Call your doctor at once if you have:

• new or worsening problems in your stomach or esophagus such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach or esophagus pain;

• skin rash on your face or arms that worsen in sunlight; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Esbriet side effects may include:

• nausea, vomiting, loss of appetite;

• stomach pain, heartburn, upset stomach;

• diarrhea;

• headache, dizziness, tired feeling;

• weight loss;

• joint pain;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Ofev, pirfenidone, nintedanib, interferon gamma-1b, Actimmune

Warnings

Tell your doctor and pharmacist if you are allergic to pirfenidone, any other medications, or any of the ingredients in Esbriet capsules or tablets.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking Esbriet. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Before taking this medicine

To make sure Esbriet is safe for you, tell your doctor if you have ever had:

• if you smoke; or

• liver or kidney disease.

It is not known if pirfenidone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Esbriet?

Take Esbriet exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You will need frequent blood tests to check your liver function and your next dose may be delayed based on the results.

Take Esbriet with food at the same time each day.

Esbriet is usually taken 3 times per day. Your dose needs will change over the first 15 days of your treatment. Follow your doctor's dosing instructions very carefully.

You should not take more than 3 doses per day.

If you stop using this medicine, do not start it again without your doctor's advice.

Store tightly closed at room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

Initial dose:
-Days 1 to 7: 267 mg (one capsule) orally three times a day
-Days 8 to 14: 534 mg (two capsules) orally three times a day
Maintenance/Maximum dose (Day 15 onward): 801 mg (three capsules) orally three times a day

Comments:
-Take with food to reduce nausea and dizziness.
-Doses should be taken at the same time each day.

Use: Idiopathic pulmonary fibrosis (IPF)

What happens if I miss a dose?

Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Esbriet?

Esbriet could make you sunburn more easily. Avoid sunlight, tanning beds and other medications that can make your skin sensitive to sunlight. Wear protective clothing and use sunscreen (SPF 50 or higher) when you are outdoors.

Avoid smoking while taking this medicine. Smoking could make Esbriet less effective.

What other drugs will affect Esbriet?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may interact with pirfenidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Ingredients

Active ingredient: pirfenidone.
Inactive ingredients: Capsules, microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmel lose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.
Tablets, microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmel lose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.

Manufacturer

Distributed by: Genentech USA, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.

Popular FAQ

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Esbriet only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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