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Esbriet

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Esbriet (pirfenidone) is an anti-fibrotic medication used to treat idiopathic pulmonary fibrosis (IPF). It helps slow the progression of the disease by reducing lung tissue scarring and inflammation. This treatment aids in maintaining lung function and improving the breathing capacity of adults affected by this chronic respiratory condition.


Ingredient
Availability
In Stock
Delivery Time
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Active Ingredient(s)
Pirfenidone
Manufacturer
Roche
Product Form
Capsule, Film-coated tablet
Regulatory Classification
Rx
Primary Category
Lung Health, Breathing Support
Product Category
Respiratory Systems, Immunosuppressants
Pharmacological Class
Pyridinones, Antifibrotics
Manufacturer Description
Esbriet is a specialist medication used to treat adults with idiopathic pulmonary fibrosis, helping to slow down the decline in lung function and scarring.
Mechanism of Action
The medication reduces lung fibrosis (scarring) by interfering with the production of growth factors and cytokines involved in the inflammatory and fibrotic processes, helping to slow the progression of lung disease.
Route of Administration
Oral
Onset Time
Several weeks
Duration
Continuous (daily dosing)
Contraindications
Severe liver disease, Severe kidney disease, Concurrent use of fluvoxamine
Severe Adverse Events
Liver enzyme elevation, Jaundice, Angioedema, Severe photosensitivity
Common Side Effects
Nausea, Fatigue, Heartburn
Uncommon Side Effects
Weight loss, Sun sensitivity, Skin rash, Indigestion
Drug Interactions
Fluvoxamine, Ciprofloxacin, Smoking, Grapefruit juice
Pregnancy Safety Warnings
Avoid use unless strictly necessary; consult a specialist.
Age Restrictions
Adults only; safety in children not established.
Storage Guidelines
Keep container tightly closed. Store at room temperature.
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Esbriet FAQ

Can I take Esbriet with other antifibrotic drugs?

Co-administration of pirfenidone with other antifibrotic agents such as nintedanib has not been widely studied. Combining these therapies should only be considered in a specialist centre where patients can be closely monitored for additive side effects, particularly liver toxicity.

Is smoking allowed while I am on Esbriet?

Smoking induces the CYP1A2 enzyme, which can lower pirfenidone plasma concentrations and potentially reduce its effectiveness. Smoking cessation is strongly recommended for anyone receiving Esbriet.

How does the appearance of the pills differ between strengths?

  • 200 mg tablets are typically white, round, and imprinted with “200”.
  • 400 mg tablets are usually blue, oval, and marked “400”. Regional packaging variations may exist, so always verify the imprint with your pharmacist.

Will Esbriet show up on a drug test for athletes?

Pirfenidone is not listed as a prohibited substance by the World Anti-Doping Agency (WADA). However, athletes should disclose all medications to their anti-doping organization, as formulation excipients or metabolites could occasionally trigger alerts.

Does Esbriet interact with over-the-counter antihistamines?

Common antihistamines (e.g., cetirizine, loratadine) do not significantly affect pirfenidone metabolism and are generally considered safe. Nonetheless, patients should inform their healthcare provider of all OTC medicines they use.

Can I travel internationally with Esbriet tablets?

Yes, but keep the medication in its original labelled container, carry a copy of the prescription, and be aware of any import restrictions in the destination country. The UK’s NHS travel advice recommends a maximum of 30 days’ supply without additional documentation.

What should I do if I develop a rash after sun exposure?

Immediately discontinue sun exposure, apply a soothing, fragrance-free moisturizer, and seek medical evaluation. Severe or widespread photosensitivity may require temporary cessation of Esbriet.

Is it safe to take Esbriet with a high-protein diet?

Pirfenidone absorption is not significantly affected by dietary protein content. The important factor is taking the tablets with food to minimise gastrointestinal upset.

How are unused tablets disposed of safely?

Unused Esbriet tablets should be returned to a pharmacy collection point or disposed of according to the NHS “Dispose of medicines safely” programme. Do not flush tablets down the toilet.

Are there generic versions of pirfenidone available in the UK?

As of the current regulatory landscape, pirfenidone is marketed primarily under the brand name Esbriet in the UK. Generic equivalents may become available after patent expiry, but patients should only use products approved by the MHRA.

What is Esbriet?

Esbriet is a brand-name medication that contains pirfenidone as its active ingredient. It is supplied as oral pills in strengths of 200 mg and 400 mg. In the United Kingdom, Esbriet is a prescription-only medicine (Rx) regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The drug is primarily prescribed for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic, progressive lung disease that leads to scarring (fibrosis) of lung tissue and causes breathing difficulties.

How Pirfenidone Works in the Body

Pirfenidone belongs to a class of agents that modify the body’s response to injury within lung tissue. Its exact mechanism is not fully understood, but research shows several key actions:

  • Anti-fibrotic effect: Pirfenidone suppresses the activity of fibroblasts, cells that produce excess collagen and other matrix proteins that thicken lung tissue.
  • Anti-inflammatory activity: It reduces the release of inflammatory cytokines such as tumor-necrosis factor-α (TNF-α) and interleukin-1β, which contribute to lung injury.
  • Oxidative-stress reduction: By scavenging free radicals, pirfenidone helps limit oxidative damage that can trigger fibrosis.

These combined actions slow the progression of scarring, helping to preserve lung function and delay worsening of breathing problems in IPF.

Conditions Treated by Esbriet

Idiopathic Pulmonary Fibrosis (IPF)

  • Regulatory approval: In the UK, Esbriet is approved by the MHRA for the treatment of IPF in adults. The indication is based on clinical trials that demonstrated a reduction in the decline of forced vital capacity (FVC), a measure of lung function.
  • Typical patient profile: Adults with confirmed IPF, usually diagnosed through high-resolution CT scanning and pulmonary function testing. The medication is most effective when started early in the disease course.

Esbriet is not approved for asthma, chronic obstructive pulmonary disease (COPD), or other respiratory conditions. Use for those indications would be considered off-label and should only occur under specialist supervision.

Patient Suitability and Contra-indications

Who Should Use Esbriet?

  • Adults with a confirmed diagnosis of IPF.
  • Patients who can adhere to a regular dosing schedule and are able to take the medication with food.
  • Individuals without significant liver disease, as liver function must be monitored.

Absolute Contra-indications

  • Known hypersensitivity to pirfenidone or any of the tablet’s excipients.
  • Pregnancy: Pirfenidone is teratogenic and is contraindicated in pregnancy. Women of child-bearing potential must use effective contraception.
  • Severe hepatic impairment (Child-Pugh class C) or active liver disease.

Relative Contra-indications

  • Moderate hepatic impairment (Child-Pugh class B) - dose adjustments and close monitoring are required.
  • Severe renal impairment (creatinine clearance < 30 mL/min) - use with caution and monitor renal function.
  • Concomitant use of strong CYP1A2 inhibitors (e.g., fluvoxamine) - may increase pirfenidone plasma levels.

Special Populations

  • Pregnancy & lactation: Not recommended; a risk of fetal harm exists. Breast-feeding mothers should not use Esbriet.
  • Elderly: No specific dosage change, but increased monitoring for liver toxicity is advised.
  • Pediatrics: Safety and efficacy have not been established in patients under 18 years of age.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Nausea and vomiting (often reduced when tablets are taken with food).
  • Dyspepsia (indigestion) and heartburn.
  • Diarrhoea.
  • Fatigue and dizziness.
  • Photosensitivity reactions, presenting as a rash after sun exposure.

Serious Adverse Events

  • Liver injury: Elevated liver enzymes (ALT, AST) have been reported; severe hepatitis is rare but requires immediate medical attention.
  • Severe photosensitivity: Large, blistering skin reactions can occur with prolonged sun exposure; protection is essential.
  • Interstitial lung disease exacerbation: While pirfenidone aims to slow fibrosis, any sudden worsening of respiratory symptoms should be assessed promptly.

Drug Interactions

  • CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can raise pirfenidone levels, increasing the risk of toxicity. Dose reduction or alternative therapy may be needed.
  • CYP1A2 inducers (e.g., smoking, rifampicin) reduce pirfenidone concentrations, potentially diminishing its efficacy. Smoking cessation is strongly advised.
  • Warfarin: Pirfenidone may potentiate anticoagulant effects; regular INR monitoring is recommended when both drugs are used.
  • Other medications metabolised by CYP1A2 (e.g., theophylline) may require dose adjustment.

Food and Lifestyle Interactions

  • Take with food: Consuming the tablet with a meal reduces gastrointestinal upset.
  • Sun protection: Use broad-spectrum sunscreen (SPF ≥ 30), wear protective clothing, and avoid prolonged sun exposure to minimise photosensitivity.
  • Alcohol: Moderate intake is permissible, but excessive alcohol can increase liver toxicity risk.

How to Take Esbriet

Standard Dosing Schedule

Pirfenidone dosing follows a titration protocol to improve tolerability:

  • Weeks 1-2: 200 mg tablet taken three times daily (600 mg total per day) with food.
  • Weeks 3-4: Increase to 400 mg tablet three times daily (1,200 mg total per day).
  • Week 5 onward: Maintain at 600 mg tablet three times daily (1,800 mg total per day). The 600 mg dose is achieved by taking one 200 mg and one 400 mg tablet together, or by using the appropriate combination of available strengths.

Doses should be taken at evenly spaced intervals (approximately every 8 hours) to maintain steady blood levels.

Adjustments for Special Populations

  • Moderate hepatic impairment: Start at the lowest dose (200 mg TID) and increase more slowly; monitor liver enzymes every 2 weeks during titration.
  • Severe renal impairment: Use the standard titration but conduct renal function tests monthly; discontinue if creatinine clearance falls below 30 mL/min.

Missed Dose

If a dose is missed and the next scheduled dose is more than 4 hours away, skip the missed dose and resume the regular schedule. Do not double-dose to make up for a forgotten tablet.

Overdose

Symptoms may include nausea, vomiting, abdominal pain, and severe photosensitivity. Seek emergency medical care immediately. Activated charcoal may be considered if presentation is early. No specific antidote exists; treatment is supportive.

Discontinuation

Abrupt cessation is generally safe, but patients should discuss any plan to stop therapy with their healthcare provider, especially if they have been on the maintenance dose for several months. No tapering is required, but monitoring for disease progression after discontinuation is essential.

Monitoring and Follow-Up

  • Liver function tests (ALT, AST, bilirubin): Baseline, then at weeks 2, 4, 8, and every 3 months thereafter.
  • Renal function: Baseline and periodically (at least every 6 months) if pre-existing kidney disease.
  • Pulmonary function: Spirometry (FVC) at baseline and every 6-12 months to assess disease progression.
  • Skin examination: Regular checks for photosensitivity; advise patients to report any new rash promptly.
  • Pregnancy testing: Women of child-bearing potential should have a negative pregnancy test before initiating therapy and be monitored regularly.

Storage and Handling

  • Store tablets at room temperature (15-30 °C), protected from moisture and light.
  • Keep the medication out of reach of children; use child-proof containers.
  • Do not use tablets after the expiry date printed on the packaging.
  • Unused tablets should be disposed of according to local pharmacy take-back programmes or via the NHS “Dispose of medicines safely” service.

Medication-Specific Glossary

Idiopathic Pulmonary Fibrosis (IPF)
A chronic, progressive lung disease of unknown cause characterized by the formation of scar tissue (fibrosis) that stiffens the lungs and impairs oxygen exchange.
Photosensitivity
An exaggerated skin reaction to ultraviolet (UV) radiation, resulting in rash or burns after relatively short sun exposure.
CYP1A2
An enzyme in the liver responsible for metabolising many drugs, including pirfenidone; its activity can be altered by other substances.
Titration
A gradual increase in medication dose to reach the therapeutic level while minimizing side-effects.
Teratogenic
Capable of causing birth defects when a drug is taken during pregnancy.

Medical Disclaimer

This article provides educational information about Esbriet (pirfenidone) and is not a substitute for professional medical advice. Treatment decisions, including the use of any medication for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Information for Esbriet is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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