Pirfenidone

What is Pirfenidone?

• Pirfenidone (ESBRIET) is a pyridone used for the treatment of idiopathic pulmonary fibrosis (IPF).

What are the uses of this medicine?

• This medicine is used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

How does this medicine work?

• Pirfenidone (pir fen' i done) is an orally available, antiinflammatory and antifibrotic agent that is used to treat idiopathic pulmonary fibrosis.
• It is a small molecular weight phenyl substituted pyridinone that has antifibrotic activity both in vitro and in vivo.
• In animal models, pirfenidone decreases fibroblast proliferation and reduces transforming growth factor-beta (TGF-β) synthesis and activation of fibrogenic pathways.
• In several prospective, placebo controlled trials, pirfenidone was found to reduce the progression of fibrosis and worsening of lung function in patients with idiopathic pulmonary fibrosis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• The concomitant administration of ESBRIET and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended.
• Concomitant administration of ESBRIET and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to ESBRIET.
• Discontinue use of strong CYP1A2 inducers prior to ESBRIET treatment and avoid the concomitant use of ESBRIET and a strong CYP1A2 inducer.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Conduct liver function tests prior to initiating treatment with ESBRIET.

Recommended Dosage:

• The recommended daily maintenance dosage of ESBRIET is 801 mg (three 267 mg capsules) three times a day with food for a total of 2403 mg/day. Doses should be taken at the same time each day.

Upon initiation of treatment, titrate to the full dosage of nine capsules per day over a 14-day period as follows:

Treatment days	Dosage
Days 1 through 7	1 capsule three times a day with food
Days 8 through 14	2 capsules three times a day with food
Days 15 onward	3 capsules three times a day with food

• Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions.

Administration

• Take ESBRIET exactly as your doctor tells you to take it.
• Your doctor may change your dosage of ESBRIET as needed.
• Take ESBRIET with food. This may help to decrease nausea and dizziness.
• Take 1 ESBRIET capsule 3 times each day for days 1 through 7.
• Take 2 ESBRIET capsules 3 times each day for days 8 through 14.
• Take 3 ESBRIET capsules 3 times each day on day 15 and each day after.
• If you miss a dose of ESBRIET take your next dose as soon as you remember.
• Do not take 2 doses at the same time to make up for your missed dose.
• Do not more than 3 doses each day.
• If you take too much ESBRIET, call your doctor or go to the nearest hospital emergency room right away.
• Your doctor should do certain blood tests before you start taking ESBRIET.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 267 mg

This medicine is available in fallowing brand namesː

• ESBRIET

What side effects can this medication cause?

The most common side effects of this medicine include:

• tired
• headache
• dizziness
• decreased or loss of appetite

ESBRIET may cause serious side effects, including:

• liver problems
• sensitivity to sunlight (photosensitivity) and rash
• stomach problems

What special precautions should I follow?

• Photosensitivity and rash have been noted with ESBRIET. 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 (SPF50) 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.
• Avoid smoking. Smoking may affect how well ESBRIET works.
• ALT, AST, and bilirubin elevations have occurred with ESBRIET. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required.
• Nausea, vomiting, diarrhea, dyspepsia, gastro-esophageal reflux disease, and abdominal pain have occurred with ESBRIET. Temporary dosage reductions or discontinuations may be required.

What to do in case of emergency/overdose?

• There is limited clinical experience with overdosage.

Management of overdosage:

• In the event of a suspected overdosage, appropriate supportive medical care should be provided, including monitoring of vital signs and observation of the clinical status of the patient.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of ESBRIET in pregnant women.
• ESBRIET should be used during pregnancy only if the benefit outweighs the risk to the patient.

Can this medicine be used in children?

• Safety and effectiveness of ESBRIET in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: pirfenidone
• Inactive ingredients: 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

Who manufactures and distributes this medicine?

• Manufactured for:

InterMune, Inc. Brisbane

ESBRIET is a registered U.S. trademark of InterMune, Inc. © 2014 InterMune, Inc.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).
• Keep the bottle tightly closed.
• Do not use if the seal over the bottle opening is broken or missing.

• Dailymed label info on Pirfenidone
• FDA Pirfenidone

Pirfenidone Resources
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