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.

Product dosage: 200 mg
Package (num)	Per pill	Price	Buy
30	3.90 $	117.00 $ (0%)	🛒 Add to cart
60	3.55 $	234.00 $ 212.94 $ (9%)	🛒 Add to cart
90	3.46 $	351.00 $ 311.22 $ (11%)	🛒 Add to cart
120	3.20 $ Best per pill	468.00 $ 383.76 $ (18%)	🛒 Add to cart

Esbriet (pirfenidone) is an oral antifibrotic medication specifically indicated for the treatment of idiopathic pulmonary fibrosis (IPF). It is a disease-modifying agent that targets the underlying pathological processes of IPF, working to slow the decline in lung function. By reducing the rate of forced vital capacity (FVC) decline, Esbriet helps to preserve respiratory capacity over time. This therapy represents a cornerstone in the management of this chronic, progressive, and ultimately fatal lung disease, offering a targeted approach to a condition with limited treatment options.

Features

• Active pharmaceutical ingredient: Pirfenidone
• Available in 267 mg and 801 mg film-coated tablets
• Oral administration
• Triple mechanism of action: antifibrotic, anti-inflammatory, antioxidant
• Dosed three times daily with food

Benefits

• Slows disease progression by reducing the rate of decline in forced vital capacity (FVC).
• Decreases the risk of all-cause mortality in patients with idiopathic pulmonary fibrosis.
• Helps to preserve functional capacity and physical activity for a longer duration.
• Provides a well-characterized safety and efficacy profile based on extensive clinical trial data.
• Offers an oral treatment option that can be managed in an outpatient setting.

Common use

Esbriet is exclusively indicated for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a specific type of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults. It is characterized by a progressive and irreversible decline in lung function. Diagnosis must be established by a physician experienced in the diagnosis and management of interstitial lung diseases, typically through a multidisciplinary discussion (MDD) that incorporates high-resolution computed tomography (HRCT) findings and, in some cases, histopathology. Esbriet is not indicated for other forms of interstitial lung disease (ILD) unless specified by new clinical evidence and regulatory approval.

Dosage and direction

The dosage of Esbriet must be titrated to the full maintenance dose over a 14-day period to improve gastrointestinal tolerability.

• Days 1-7: 267 mg (one tablet) three times daily (801 mg/day total).
• Days 8-14: 534 mg (two 267 mg tablets) three times daily (1602 mg/day total).
• Maintenance Dose (from Day 15 onward): 801 mg (one tablet) three times daily (2403 mg/day total).

Esbriet must be taken with food to reduce the incidence of nausea and dizziness. Tablets should be swallowed whole and not crushed, split, or chewed. If gastrointestinal symptoms persist despite administration with food, dose reduction or temporary interruption may be considered, followed by re-titration to the full maintenance dose.

Precautions

• Liver Function: Elevations in liver enzymes (ALT, AST, bilirubin) have been observed. Liver function tests (ALT, AST, and bilirubin) should be conducted prior to initiation, monthly for the first 6 months, and then every 3 months thereafter. Dosage modification or discontinuation is required for significant elevations.
• Photosensitivity and Rash: Esbriet can cause serious photosensitivity reactions and rash. Patients should be advised to avoid direct sunlight (including sunlamps), use a high-factor sunblock (SPF 50+), and wear protective clothing to minimize exposure to sunlight and UV light during treatment.
• Gastrointestinal Disorders: Nausea, diarrhea, dyspepsia, vomiting, and gastroesophageal reflux disease are common. Administering with food is essential. Anti-emetic or anti-diarrheal agents may be considered.
• Weight Loss: Patients should have their weight monitored regularly. Unexplained or significant weight loss may require further clinical evaluation and potential dose interruption.
• Smoking: Cigarette smoking may reduce the exposure to pirfenidone, potentially diminishing its efficacy. Patients should be advised to stop smoking prior to and during treatment.

Contraindications

Esbriet is contraindicated in patients with:

• A known hypersensitivity to pirfenidone or any of the excipients in the formulation.
• Severe hepatic impairment or end-stage liver disease.
• Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis.
• Concomitant use of fluvoxamine or other strong inhibitors of CYP1A2, due to the risk of significantly increased pirfenidone exposure.

Possible side effects

The most common adverse reactions (incidence >10% and more common than placebo) are:

• Nausea
• Rash
• Abdominal pain
• Upper respiratory tract infection
• Diarrhea
• Fatigue
• Headache
• Dyspepsia
• Dizziness
• Vomiting
• Anorexia
• Gastro-esophageal reflux disease
• Sinusitis
• Insomnia
• Weight decreased
• Arthralgia

Serious side effects can include drug-induced liver injury and severe photosensitivity reactions.

Drug interaction

Esbriet is primarily metabolized by the cytochrome P450 isoenzyme CYP1A2, with minor contributions from other CYP isoenzymes.

• Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin): Concomitant use is contraindicated. These agents significantly increase pirfenidone exposure, raising the risk of adverse effects.
• Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin): Use with caution. A dose reduction of Esbriet may be necessary.
• CYP1A2 Inducers (e.g., omeprazole, smoking): May decrease pirfenidone exposure, potentially reducing its efficacy. Cigarette smoking should be avoided.
• Agents Causing Drowsiness/Dizziness (CNS depressants): Pirfenidone may cause dizziness and fatigue. Additive effects are possible with other CNS depressants (e.g., benzodiazepines, opioids, antipsychotics, antidepressants).

Missed dose

If a dose is missed, it should be skipped if the next dose is due within 3 hours. The patient should then resume the normal dosing schedule with the next dose. Do not take two doses at the same time to make up for a missed dose.

Overdose

There is limited experience with pirfenidone overdose. Single doses up to 4005 mg and repeated doses up to 3003 mg daily for up to 7 days have been tolerated in clinical trials, with adverse events similar to those seen at lower doses. In suspected overdose, symptomatic and supportive medical treatment should be initiated. There is no known specific antidote. Monitoring of liver function tests and observation for signs of drowsiness or dizziness is recommended.

Storage

• Store Esbriet tablets at room temperature, between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Keep the medication in its original bottle to protect it from light.
• Keep out of reach of children and pets.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

“Clinical trial data from the ASCEND and CAPACITY studies consistently demonstrated that pirfenidone (Esbriet) significantly reduces the rate of decline in FVC percent predicted compared to placebo. This translated to a clinically meaningful benefit for patients, with a reduction in the risk of disease progression. While the side effect profile requires diligent management, particularly regarding GI events and photosensitivity, the drug’s ability to modify the course of IPF has established it as a fundamental therapy in our treatment arsenal.” – Pulmonologist, Academic Medical Center

“In my practice, initiating and managing patients on Esbriet requires a structured approach with careful patient education. Setting clear expectations about the titration schedule, the absolute necessity of taking it with food, and stringent sun protection measures are paramount for adherence and tolerability. For patients who can tolerate the full dose, the stabilization of their lung function on serial PFTs is a rewarding outcome that underscores the drug’s efficacy.” – Interstitial Lung Disease Nurse Specialist