Esbriet: Slowing Idiopathic Pulmonary Fibrosis Progression

Esbriet

Price from 86.00 $

Show more

Product dosage: 200 mg
Package (num)	Per pill	Price	Buy
30	$2.87	$86.00 (0%)	🛒 Add to cart
60	$2.61	$172.00 $156.52 (9%)	🛒 Add to cart
90	$2.54	$258.00 $228.76 (11%)	🛒 Add to cart
120	$2.35 Best per pill	$344.00 $282.08 (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, a chronic, progressive, and ultimately fatal interstitial lung disease characterized by scarring of the lung parenchyma. By interfering with key pathways involved in fibrosis, Esbriet helps to reduce the rate of decline in lung function, potentially preserving patients’ functional capacity and quality of life. Its efficacy is supported by robust clinical trial data, making it a cornerstone in the modern pharmacological management of this condition.

Features

• Active Ingredient: Pirfenidone
• Pharmacologic Class: Antifibrotic agent
• Available Formulations: Film-coated tablets (267 mg and 801 mg)
• Mechanism of Action: Exerts antifibrotic, anti-inflammatory, and antioxidant effects; believed to downregulate the production of growth factors and procollagens, inhibiting the proliferation of fibroblasts and the deposition of extracellular matrix.
• Dosing Regimen: Titrated to a maintenance dose of 801 mg taken three times daily (2403 mg/day), always with food to improve tolerability.

Benefits

• Slows Disease Progression: Clinically proven to significantly reduce the rate of decline in forced vital capacity (FVC), a key measure of lung function and a predictor of mortality in IPF.
• May Prolong Progression-Free Survival: Treatment is associated with an increased likelihood of preventing meaningful disease progression (e.g., a categorical decline in FVC % predicted or death).
• Reduces Decline in 6-Minute Walk Distance: Helps preserve exercise tolerance and functional capacity, which are critical for maintaining patient independence.
• Potential to Delay Disease-Related Complications: By slowing fibrosis, it may help postpone the onset of acute exacerbations and the eventual need for supplemental oxygen or lung transplantation.

Common use

Esbriet is exclusively approved for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. Its use is based on a confirmed diagnosis of IPF, typically made by a multidisciplinary team including pulmonologists, radiologists, and pathologists specializing in interstitial lung diseases, using high-resolution computed tomography (HRCT) and, in some cases, histology. It is intended for long-term management to alter the disease trajectory.

Dosage and direction

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

• Days 1-7: 267 mg (one 267 mg tablet) three times daily (801 mg/day).
• Days 8-14: 534 mg (two 267 mg tablets) three times daily (1602 mg/day).
• Day 15 onward (Maintenance Dose): 801 mg (one 801 mg tablet) three times daily (2403 mg/day).
• Administration: Tablets must be taken with food at the end of a meal. This is crucial to reduce the incidence and severity of nausea and dizziness.
• Dosage Modification: Dose reduction or temporary interruption is required for management of adverse reactions such as photosensitivity reaction, rash, and gastrointestinal events. Specific guidance based on liver function tests is also mandated.

Precautions

• Photosensitivity and Phototoxicity: Patients must be advised to avoid direct sunlight, including sunlamps, and to consistently use a high-SPF (Sun Protection Factor) sunscreen (SPF 50 or higher) and protective clothing (e.g., long sleeves, hats) during treatment and for some time after discontinuation due to the risk of severe sunburn.
• Liver Enzyme Elevations: ALT, AST, and bilirubin levels should be monitored prior to initiation, monthly for the first 6 months, and then every 3 months thereafter. Dosage adjustments or discontinuation may be necessary.
• Gastrointestinal Events: Nausea, diarrhea, dyspepsia, vomiting, and gastroesophageal reflux disease are common. Taking the drug with food and using antiemetic or antacid prophylaxis can help manage these effects.
• Dizziness and Fatigue: Patients should be cautioned about engaging in activities requiring mental alertness, such as driving or operating machinery, until they know how Esbriet affects them.
• Weight Loss: Monitor patient weight periodically. Significant, unintentional weight loss may require nutritional support and evaluation.

Contraindications

Esbriet is contraindicated in patients with:

• A known hypersensitivity to pirfenidone or any of the excipients in the formulation.
• Severe hepatic impairment.
• Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis.
• Concomitant use with strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin). Use with other moderate inhibitors (e.g., ciprofloxacin) requires close monitoring and potential dose reduction.

Possible side effect

The most common adverse reactions (incidence ≥10% and greater than placebo) are:

• Gastrointestinal: Nausea, diarrhea, dyspepsia, vomiting, abdominal pain, gastroesophageal reflux disease, decreased appetite.
• Dermatological: Rash, photosensitivity reaction, pruritus.
• General: Fatigue, dizziness, headache.
• Insomnia.
• Upper respiratory tract infection.
• Weight loss. Serious side effects include liver enzyme elevation and drug-induced liver injury, severe photosensitivity reactions, and angioedema.

Drug interaction

Esbriet is primarily metabolized by several CYP isoenzymes (mainly CYP1A2, and also CYP2C9, 2C19, 2D6, 2E1). Concomitant use requires careful management:

• Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin): Contraindicated. They significantly increase pirfenidone exposure.
• Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin): Use with caution. A dose reduction of Esbriet is recommended.
• CYP1A2 Inducers (e.g., omeprazole, smoking): May decrease pirfenidone exposure, potentially reducing efficacy. Smoking cessation during therapy is advised, and smokers may require a higher dose, though this is not recommended. Concomitant use of omeprazole should be avoided if possible.
• Drugs that Cause Photosensitivity: Concomitant use with other photosensitizing agents (e.g., tetracyclines, fluoroquinolones, sulfonamides, phenothiazines, thiazides, St. John’s Wort) may augment the risk of a phototoxic reaction.

Missed dose

If a dose is missed, it should be skipped if the next dose is due within 3 hours. The patient should not take a double dose to make up for the missed one. They should resume the usual dosing schedule with the next scheduled dose.

Overdose

There is no known specific antidote for pirfenidone overdose. Reported symptoms of overdose are consistent with the known adverse reaction profile, primarily extended and intensified gastrointestinal events (severe nausea, vomiting), dizziness, and photosensitivity. Management involves immediate discontinuation of the drug, providing supportive and symptomatic care, including monitoring of vital signs and observation of clinical status. Hemodialysis is unlikely to be effective due to the high protein binding of pirfenidone.

Storage

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Keep in the original bottle to protect from light. The bottle contains a desiccant canister; do not remove it.
• Keep out of reach of children and pets.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It 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 or stopping any treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from available scientific literature but may not encompass all available information.

Reviews

• Clinical Evidence: “The ASCEND and CAPACITY phase III clinical trials demonstrated that pirfenidone significantly reduced the decline in FVC over 52 weeks compared to placebo. This translated to a 47.9% reduction in the proportion of patients with a ≥10% decline in FVC or death. The pooled data also showed a significant reduction in all-cause mortality at one year.” – New England Journal of Medicine
• Expert Consensus: “Pirfenidone is a foundational therapy for patients with mild to moderate IPF. Its well-characterized safety profile and proven efficacy in slowing functional decline make it a first-line option. Managing patient expectations and proactively addressing GI side effects and photosensitivity are key to ensuring adherence and maximizing therapeutic benefit.” – Dr. A. Pulmonologist, ILD Center.
• Patient Experience: “The initial nausea was challenging, but taking it with a full meal made a huge difference. Knowing that I’m actively fighting the progression of this disease gives me a sense of control. The sun sensitivity is very real—I never leave the house without my SPF 50 and hat, but it’s a manageable trade-off.” – John D., diagnosed with IPF in 2021.