Esbriet Slows Idiopathic Pulmonary Fibrosis Progression

Esbriet

Esbriet
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, working to slow the decline in lung function. By reducing the rate of forced vital capacity (FVC) decline, Esbriet helps to preserve patients’ functional capacity and may improve long-term outcomes in this progressive and ultimately fatal condition. Treatment is managed by specialist physicians within a comprehensive care plan.

Features

  • Active pharmaceutical ingredient: Pirfenidone
  • Available as hard capsules or film-coated tablets for oral administration
  • Standard strengths: 267 mg capsules and 601 mg tablets
  • Dosed three times daily with food
  • Manufactured under strict pharmaceutical quality control standards
  • Requires a prescription from a qualified healthcare provider

Benefits

  • Slows Disease Progression: Clinically proven to reduce the rate of decline in lung function, as measured by forced vital capacity (FVC).
  • Preserves Functional Capacity: By slowing fibrosis, it can help maintain patients’ ability to perform daily activities for a longer period.
  • Improves Mortality Outcomes: Associated with a reduction in all-cause mortality risk in patients with idiopathic pulmonary fibrosis.
  • Well-Characterized Efficacy: Supported by robust clinical trial data from multiple phase III studies (CAPACITY, ASCEND).
  • Oral Administration: Convenient tablet or capsule form eliminates the need for invasive administration.

Common use

Esbriet is exclusively indicated for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, fibrosing interstitial pneumonia of unknown cause, characterized by a progressive and irreversible decline in lung function. It is primarily diagnosed and managed by pulmonologists. Esbriet is not indicated for other interstitial lung diseases (ILDs) unless a diagnosis of IPF has been conclusively established by a multidisciplinary team using high-resolution computed tomography (HRCT) and, when necessary, histopathology.

Dosage and direction

Dosage must be titrated to the full maintenance dose to improve tolerability. The following is a standard titration schedule over a 14-day period:

  • Days 1-7: 267 mg (one capsule) three times daily (801 mg/day).
  • Days 8-14: 534 mg (two capsules or one 601 mg tablet) three times daily (1602 mg/day).
  • Maintenance Dose (Day 15 onward): 801 mg (three capsules or one 601 mg plus one 267 mg capsule) three times daily (2403 mg/day).

Esbriet must be taken with food to reduce the incidence of nausea and dizziness. The capsules should be swallowed whole. Do not crush or chew the capsules or tablets. Dosage adjustment or interruption is required for patients who experience significant adverse reactions or have hepatic impairment.

Precautions

  • Photosensitivity: Esbriet can cause serious skin reactions to sunlight and UV light. Patients must use a high-SPF (50+) sunscreen, wear protective clothing, and avoid direct sun exposure, including sunlamps, during treatment.
  • 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 Events: Nausea, diarrhea, dyspepsia, vomiting, and gastroesophageal reflux disease are common. Taking Esbriet with food can mitigate these effects. Anti-emetic or anti-diarrheal agents may be considered.
  • Dizziness and Fatigue: Patients should be cautioned about operating machinery or driving until they know how Esbriet affects them.
  • Weight Loss: Monitor patient weight. Significant unintentional weight loss may require dietary consultation and potential dose modification.

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).
  • End-stage renal disease requiring dialysis.
  • History of severe photosensitivity reaction or phototoxicity during treatment with Esbriet.

Possible side effect

The most common adverse reactions (occurring in ≥10% of patients) include:

  • Nausea
  • Rash
  • Abdominal pain
  • Upper respiratory tract infection
  • Diarrhea
  • Fatigue
  • Headache
  • Dyspepsia
  • Dizziness
  • Vomiting
  • Anorexia (loss of appetite)
  • Photosensitivity reaction
  • Insomnia

Serious but less common side effects can include severe liver injury and severe photosensitivity reactions.

Drug interaction

Esbriet is primarily metabolized by several CYP isoenzymes (including CYP1A2). Concomitant use of drugs that inhibit or induce these enzymes can significantly alter pirfenidone exposure.

  • Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin): Concomitant use is not recommended. May lead to a substantial increase in pirfenidone exposure.
  • Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin): Use with caution. A dose reduction of Esbriet may be required.
  • CYP1A2 Inducers (e.g., omeprazole, smoking): May decrease pirfenidone exposure, potentially reducing efficacy. Smokers may require a higher dose, though smoking cessation is strongly advised for IPF patients. Dose adjustments should be managed by a physician.
  • Other Medications: Inform your doctor of all other medications you are taking, including over-the-counter drugs and herbal supplements.

Missed dose

If a dose is missed, it should be skipped if the next dose is due within 3 hours. Do not double the next dose to make up for a missed dose. Resume the normal dosing schedule with the next dose. If vomiting occurs shortly after taking a dose, do not take an additional dose; wait until the next scheduled dose time.

Overdose

There is limited experience with pirfenidone overdose. In clinical trials, single doses up to 4005 mg were administered and were associated with an increased incidence of adverse reactions. In the event of a suspected overdose, symptomatic and supportive medical treatment should be initiated. There is no known specific antidote for pirfenidone overdose. Management should include monitoring of vital signs and observation of the patient’s clinical status.

Storage

  • Store Esbriet 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 bottle tightly closed in its original container to protect from moisture and light.
  • Keep out of the reach of children and pets.
  • Do not use medicine that is out of date or shows signs of deterioration.

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 medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from publicly available prescribing information but may not be exhaustive or fully updated.

Reviews

“After my IPF diagnosis, the decline in my breathing was frightening. Starting on Esbriet was a decision made with my pulmonologist. The titration was a bit rough with some nausea, but taking it with a full meal helped immensely. A year into treatment, my FVC has remained remarkably stable. The strict sun precautions are a small price to pay for this stability.” – James R., patient.

“The data from the ASCEND trial was a turning point in IPF management. In my practice, I’ve seen Esbriet effectively slow functional decline in a significant proportion of my appropriate patients. Managing side effects, particularly GI issues and photosensitivity, through patient education and proactive support is key to ensuring adherence and achieving the best possible outcomes.” – Dr. Eleanor Vance, Pulmonologist.

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