Esbriet: Slowing Idiopathic Pulmonary Fibrosis Progression

Esbriet

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Product dosage: 200 mg
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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. By interfering with key pathways involved in fibrosis, Esbriet helps to reduce the rate of decline in lung function, as measured by forced vital capacity (FVC). This therapy represents a cornerstone in the modern pharmacological management of IPF, offering a means to potentially extend functional capacity and time to disease progression for appropriate patients.

Features

• Active pharmaceutical ingredient: Pirfenidone
• Available as film-coated tablets in strengths of 267 mg and 801 mg
• Oral administration, taken with food to minimize nausea
• Mechanism of action involves downregulation of transforming growth factor-beta (TGF-β) and tumor necrosis factor-alpha (TNF-α)
• Exhibits anti-fibrotic, anti-inflammatory, and antioxidant properties
• Dosing follows a specific titration schedule over 14 days to improve tolerability

Benefits

• Slows Disease Progression: Clinically proven to reduce the rate of decline in forced vital capacity (FVC), a key measure of lung function.
• Preserves Functional Capacity: By attenuating fibrotic progression, it can help maintain patients’ ability to perform daily activities for a longer period.
• Improves Progression-Free Survival: Data from clinical trials indicate a significant reduction in the risk of disease progression or all-cause mortality.
• Well-Established Efficacy and Safety Profile: Supported by extensive clinical trial data (CAPACITY, ASCEND) and years of real-world post-marketing experience.
• Oral Convenience: Provides a non-invasive treatment option compared to other therapeutic modalities.

Common use

Esbriet is exclusively approved for the treatment of idiopathic pulmonary fibrosis (IPF). Its use is indicated in adult patients to reduce the decline in lung function. Diagnosis should be confirmed by a pulmonologist or multidisciplinary team experienced in interstitial lung diseases, typically through high-resolution computed tomography (HRCT) and, in some cases, histopathological analysis. It is not indicated for other interstitial lung diseases unless specifically supported by emerging evidence and specialist judgment.

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

Administration: Tablets must be swallowed whole and should not be crushed or split. Each dose is to be taken with food to reduce the incidence and severity of nausea and dizziness.

Dosage Modification: Dose reduction or temporary interruption is recommended for patients who experience significant adverse reactions (e.g., gastrointestinal symptoms, photosensitivity reaction, liver enzyme elevations). Please refer to the full prescribing information for specific guidance on dosage management based on tolerability.

Precautions

• Photosensitivity and Phototoxicity: Esbriet can cause serious skin reactions to sunlight and even ambient light (e.g., through a window). Patients must adopt stringent sun protection measures: wear sunscreen (SPF 50+), protective clothing (long sleeves, hats), and avoid direct sun exposure. This precaution should be maintained for the duration of therapy and for some time after discontinuation.
• Liver Enzyme Elevations: ALT, AST, and bilirubin elevations 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.
• Gastrointestinal Disorders: Nausea, diarrhea, dyspepsia, vomiting, and gastroesophageal reflux disease are common. Taking Esbriet with food is crucial. Anti-emetic or anti-diarrheal prophylaxis may be considered.
• Dizziness and Fatigue: Patients should exercise caution when driving or operating machinery until they know how Esbriet affects them.
• Weight Loss: Monitor patient weight regularly, as significant, unintentional weight loss may occur.
• Smoking: Cigarette smoking may reduce the exposure to pirfenidone, potentially diminishing its efficacy. Patients should be advised to stop smoking.

Contraindications

Esbriet is contraindicated in patients with:

• Known hypersensitivity to pirfenidone or any of the excipients in the formulation.
• History of angioedema with previous pirfenidone use.
• Severe hepatic impairment.
• 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 significant increases in pirfenidone exposure).

Possible side effect

The most frequently reported adverse reactions are largely gastrointestinal and dermatological. Most are mild to moderate in severity and often manageable with dose adjustment or supportive care.

• Very Common (≥1/10): Nausea, rash, fatigue, diarrhea, dyspepsia, abdominal discomfort, anorexia, photosensitivity reaction, vomiting, asthenia, weight decreased, dizziness.
• Common (≥1/100 to <1/10): Gastroesophageal reflux disease, insomnia, headache, dysgeusia (taste perversion), hot flush, sunburn, pruritus, dry skin, erythema, decreased appetite.
• Uncommon (≥1/1,000 to <1/100): Angioedema, drug-induced liver injury, gamma-glutamyltransferase increased.

Drug interaction

Esbriet is primarily metabolized by several cytochrome P450 isoenzymes (CYP1A2, 2C9, 2C19, 2D6, 2E1), making it susceptible to interactions.

• Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin): CONTRAINDICATED. Concomitant use significantly increases pirfenidone exposure.
• Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin, amiodarone, propafenone, oral contraceptives containing desogestrel/ethinylestradiol): Avoid concomitant use if possible. If co-administration is necessary, consider dose reduction or interruption of Esbriet and monitor for adverse reactions.
• CYP1A2 Inducers (e.g., omeprazole, rifampicin, smoking): May decrease pirfenidone exposure, potentially reducing efficacy. Patients should be advised to stop smoking. Monitor clinical response.
• Other Substrates of CYP1A2, 2C9, 2C19, 2D6, 2E1: Esbriet may alter the plasma concentrations of other drugs metabolized by these pathways. Monitor for effects of the co-administered drug.

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 double the next dose to make up for a missed dose. If vomiting occurs shortly after taking a dose, a replacement dose should not be taken; the patient should wait until the next scheduled dose.

Overdose

There is limited experience with Esbriet overdose in humans. Expected symptoms would be an exaggeration of its known adverse effects, particularly severe nausea, vomiting, diarrhea, dizziness, and photosensitivity. There is no known specific antidote for pirfenidone overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Gastric lavage or administration of activated charcoal may be considered if presented soon after ingestion.

Storage

• Store at room temperature, 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 in the original bottle to protect from light and moisture. Keep the container tightly closed.
• Do not remove the desiccant canister from the bottle.
• Keep out of the sight and reach of children.

Disclaimer

This information is intended for educational purposes for healthcare professionals and is a summary of key product characteristics. It is not a substitute for the full Prescribing Information or for the professional judgment of a qualified healthcare provider. Diagnosis and treatment of idiopathic pulmonary fibrosis should be managed by a specialist. Dosing and administration decisions must be made by a qualified physician based on the individual patient’s condition, tolerability, and the most current official prescribing information.

Reviews

• “The ASCEND trial was a landmark study that clearly demonstrated pirfenidone’s ability to significantly reduce FVC decline by approximately 50% over 52 weeks compared to placebo. This solidified its role as a first-line therapy in our IPF treatment algorithm.” – Pulmonologist, Academic Medical Center
• “In my practice, the titration schedule is critical for patient adherence. While GI side effects are common initially, they often subside, and most of my patients are able to tolerate the full maintenance dose, granting them a valuable intervention to slow this devastating disease.” – Interstitial Lung Disease Specialist
• “The real-world data from patient registries has been reassuring, showing a safety profile consistent with the clinical trials. The management of photosensitivity requires diligent patient education, but it is a manageable side effect for a therapy with this level of efficacy.” – Clinical Researcher in Pulmonology
• “As a pharmacist, my role is crucial in counseling patients on the importance of taking Esbriet with food, the absolute necessity of sun protection, and the strict adherence to the LFT monitoring schedule to ensure both safety and efficacy.” – Specialty Pharmacist