Esbriet: Slows Idiopathic Pulmonary Fibrosis Progression
| 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 works by targeting multiple pathways involved in the fibrotic process, including the downregulation of key profibrotic cytokines and growth factors. By modulating the underlying disease pathology, Esbriet helps to reduce the rate of lung function decline, as measured by forced vital capacity (FVC). This therapy represents a cornerstone in the long-term management of IPF, offering a targeted approach to slow disease progression and preserve functional capacity. Treatment decisions should be made by a specialist familiar with interstitial lung diseases, following a confirmed multidisciplinary diagnosis.
Features
- Active pharmaceutical ingredient: Pirfenidone
- Available as film-coated tablets (267 mg and 801 mg) for oral administration
- Triple-mechanism antifibrotic action: modulates TGF-β, TNF-α, and PDGF pathways
- Dosing regimen involves a structured titration period to improve tolerability
- Demonstrated efficacy in reducing the decline of forced vital capacity (FVC) in clinical trials
Benefits
- Slows the progression of idiopathic pulmonary fibrosis, a chronic and life-limiting condition.
- Helps to preserve lung function over time, potentially maintaining patient mobility and independence.
- Reduces the annual rate of decline in forced vital capacity (FVC), a key predictor of mortality in IPF.
- Offers a well-characterized safety and efficacy profile supported by extensive clinical trial data (CAPACITY, ASCEND).
- Provides a targeted therapeutic option that addresses core fibrotic pathways rather than just managing symptoms.
Common use
Esbriet is exclusively indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Its use is reserved for patients with a confirmed diagnosis of IPF, typically made by a multidisciplinary team (MDT) comprising pulmonologists, radiologists, and pathologists specializing in interstitial lung disease, based on a combination of high-resolution computed tomography (HRCT) pattern and, when necessary, histopathology. It is not indicated for other interstitial lung diseases (ILDs) unless evidence supports its use in specific phenotypes under expert guidance.
Dosage and direction
The dosage of Esbriet must be titrated to the full maintenance dose to minimize the potential for gastrointestinal and photosensitivity adverse reactions.
Weeks 1-7: Titration Period
- 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) three times daily (1602 mg/day total).
- Day 15 onward (Maintenance): 801 mg (one 801 mg tablet) three times daily (2403 mg/day total).
Administration: Tablets are to be taken orally with food to reduce the likelihood of nausea. The three daily doses should be taken at approximately the same times each day (e.g., with breakfast, lunch, and dinner).
Dose modification or interruption is required for management of certain adverse reactions, such as significant photosensitivity reaction, severe nausea, diarrhea, or vomiting, or for elevations in liver enzymes. Specific guidance for dose reduction and re-titration is provided in the full prescribing information.
Precautions
- Photosensitivity and Phototoxicity: Esbriet can cause serious skin reactions due to increased sensitivity to sunlight (UVA/UVB) and artificial light sources (e.g., tanning beds). Patients must be advised to avoid sun exposure, use a high-protection (SPF 50+), broad-spectrum sunscreen, and wear protective clothing during treatment 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 thereafter, and as clinically indicated.
- Gastrointestinal Disorders: Nausea, diarrhea, dyspepsia, vomiting, and gastroesophageal reflux disease are common. These can often be managed by taking the medication with food, dose adjustment, or concomitant antiemetic/antacid therapy.
- Dizziness and Fatigue: Patients should exercise caution when driving or operating machinery until they know how Esbriet affects them, as it may cause dizziness and fatigue.
- Weight Loss: Clinically significant weight loss has been observed. Patient weight should be monitored regularly.
Contraindications
Esbriet is contraindicated in patients with:
- Known hypersensitivity to pirfenidone or any of the excipients in the formulation.
- Severe hepatic impairment (Child-Pugh Class C).
- Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis.
- Concomitant use with strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin). See Drug Interactions.
Possible side effect
The most frequently reported adverse reactions are gastrointestinal and skin-related. The following list is not exhaustive.
- Very Common (≥1/10): Nausea, rash, fatigue, diarrhea, dyspepsia, abdominal pain (upper), vomiting, anorexia, photosensitivity reaction, headache, dizziness.
- Common (≥1/100 to <1/10): Gastroesophageal reflux disease, insomnia, weight decreased, pruritus, myalgia, hot flush, asthenia.
- Uncommon (≥1/1,000 to <1/100): Liver enzyme increased (ALT, AST), gamma-glutamyltransferase increased, blood bilirubin increased, sunburn, angioedema.
- Rare (<1/1,000): Severe drug-induced liver injury.
Drug interaction
Esbriet is primarily metabolized by several CYP isoenzymes (mainly CYP1A2, and also CYP2C9, 2C19, 2D6, 2E1), making it susceptible to numerous drug interactions.
- Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin): Concomitant use is contraindicated as they significantly increase pirfenidone exposure, raising the risk of adverse effects.
- Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin, amiodarone, propafenone): Use with caution and consider dose reduction or interruption of Esbriet. Monitor patients closely for adverse reactions.
- CYP1A2 Inducers (e.g., omeprazole, cigarette smoke): May decrease pirfenidone exposure, potentially reducing efficacy. Smokers may have significantly reduced pirfenidone levels. Cessation of smoking after dose stabilization may increase exposure and require monitoring.
- Other Medicinal Products: Drugs that cause photosensitivity (e.g., tetracyclines, fluoroquinolones, sulfonamides, thiazides, St. John’s Wort) may have additive effects and increase the risk of phototoxic reactions.
A comprehensive review of a patient’s concomitant medication is essential prior to and during treatment.
Missed dose
If a dose is missed, it should be skipped and the next dose taken at the regularly scheduled time. Patients should not take a double dose to make up for a missed one. Maintaining the regular dosing schedule is important to avoid sudden peaks in drug concentration that could increase the risk of adverse effects.
Overdose
There is limited experience with Esbriet overdose in humans. Based on its pharmacological profile, symptoms of overdose may be an exaggeration of its known adverse effects, including severe nausea, vomiting, diarrhea, dizziness, and photosensitivity reaction. There is no known specific antidote for pirfenidone overdose. Management should consist of supportive and symptomatic care, including monitoring of vital signs and observation of the patient’s clinical status. Hemodialysis is unlikely to be effective due to the high protein binding of pirfenidone (~60%).
Storage
- Store in the original package to protect from light and moisture.
- Store at or below 30°C (86°F).
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the blister and carton.
Disclaimer
This information is intended for educational and informational purposes only for healthcare professionals and does not constitute medical advice. It is a summary and does not include all existing information about the medicinal product. The prescriber must rely on their own professional judgment, the patient’s clinical circumstances, and the full official prescribing information approved in their country to make definitive treatment decisions for individual patients. The author and publisher are not responsible for any errors or omissions or for any consequences from the application of this information.
Reviews
- “In my practice, Esbriet has become a fundamental therapy for suitable IPF patients. The titration protocol is key to managing initial GI side effects. The slowing of FVC decline we see in compliant patients is clinically meaningful and aligns with the trial data.” – Pulmonologist, 15 years of experience
- “The requirement for diligent sun protection cannot be overstated. Patients who adhere to this guidance tend to tolerate the therapy much better long-term. It’s a drug that demands a proactive and educated patient, but the payoff in disease modification is significant.” – Interstitial Lung Disease Nurse Specialist
- “The landmark ASCEND trial provided the Level A evidence needed to solidify pirfenidone’s role in IPF management. It’s not a cure, but it changes the trajectory of the disease, which is a substantial advancement for our patients.” – Academic Researcher in Pulmonary Medicine
- “Managing expectations is crucial. Patients must understand this is a long-term treatment to slow progression, not reverse damage. The monthly monitoring for liver function during the first half-year requires a committed healthcare team and patient.” – Respiratory Physician