Esbriet

(Pirfenidone)

The active ingredient in Esbriet is pirfenidone. Pirfenidone has antifibrotic and anti-inflammatory effects. Although the exact mechanism of action is not fully understood, it is thought that Esbriet works by reducing processes involved in the formation of scar tissue in the lungs. Clinical studies show that Esbriet slows the decline in forced vital capacity (FVC), a measure of lung function, helping to slow the progression of idiopathic pulmonary fibrosis.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Esbriet. However, the following is a synopsis of the general guidelines for the use of Esbriet:

Esbriet is taken by mouth as capsules or tablets.

It should be taken with food to reduce stomach-related side effects.

If you miss a dose, skip the missed dose and take the next one at the usual time. Do not take two doses at the same time.

Esbriet can make you more susceptible to sunburns. Take care to minimize time in direct sunlight, avoid sunlamps and tanning beds while on this medication, and always wear sunscreen (SPF 50) when going outside.

Some mild or common side effects of Esbriet seen in clinical trials include:

Nausea.

Stomach pain or discomfort.

Loss of appetite.

Weight loss.

Headache.

Dizziness.

Upper respiratory tract infections.

Fatigue.

Dyspepsia or reflux.

Some individuals may experience serious side effects while using Esbriet. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

Liver problems, including elevated liver enzymes or jaundice.

Severe skin reactions, including photosensitivity reactions or severe sunburn.

Severe allergic reaction, including hives (skin rash), swelling of the face or throat, or difficulty breathing.

Persistent gastrointestinal symptoms that do not improve.

These are not all of the possible side effects of Esbriet. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Esbriet, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Liver disease or abnormal liver function.

Kidney problems.

A history of photosensitivity or severe skin reactions.

Other lung diseases.

Use of herbal supplements or over-the-counter medications.

Pregnancy or plans to become pregnant.

Breastfeeding or plans to breastfeed.

Regular blood tests are required to monitor liver function before and during treatment.

Esbriet is contraindicated in patients with known hypersensitivity to pirfenidone or any component of the formulation.

Esbriet begins working after treatment starts, but it does not provide immediate symptom relief. Its benefit is measured over time by slowing the decline in lung function. Your healthcare provider will monitor progress through lung function tests such as forced vital capacity.

When Esbriet is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Fluvoxamine, which can significantly increase pirfenidone levels and should not be used together.

Ciprofloxacin, which may increase pirfenidone exposure and may require dose adjustment.

Strong CYP1A2 inhibitors can increase the risk of side effects.

It is available as capsules or tablets containing 267mg of pirfenidone.

It should be stored at room temperature, away from the reach of children or pets.

Esbriet is manufactured by Genentech.

Yes, it is available from many manufacturers of generic drugs.

Do not stop taking Esbriet without medical advice. If treatment must be discontinued due to side effects or abnormal blood tests, your healthcare provider will guide dose reduction or discontinuation.

It is not known if Esbriet can harm an unborn baby. Talk to your doctor if you are pregnant or planning to become pregnant so they can determine what is best for you.

It is not known if pirfenidone passes into breast milk. Talk to your healthcare provider if you are breastfeeding or planning to breastfeed so they can help weigh the benefits and risks.