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You are here: Home / Our Medicines / Esbriet

Esbriet

Esbriet is an oral medicine for patients with idiopathic pulmonary fibrosis (IPF)

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Please review the Data Sheet before prescribing.

About Esbriet

Esbriet is an oral anti-fibrotic and anti-inflammatory medicine for patients with idiopathic pulmonary fibrosis (IPF).1
Esbriet is a Prescription Medicine, available as a 267 mg oral capsule.1
For information on dosage and administration of Esbriet, please refer to the Data Sheet on the Medsafe website here.1

For a quick introduction to IPF, please watch this video,



Esbriet’s Funding Status

Esbriet is now listed on Section B and Section H of the Pharmaceutical Schedule for the treatment of idiopathic pulmonary fibrosis (IPF), under special authority criteria.2

PHARMAC Special Authority criteria for Esbriet:2

Pirfenidone is listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Retail Pharmacy - Specialist

Special Authority for Subsidy

Initial application – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has been diagnosed with idiopathic pulmonary fibrosis as confirmed by histology, CT or biopsy; and

2. Forced vital capacity is between 50% and 80% predicted; and

3. Pirfenidone is to be discontinued at disease progression (See Notes).

Renewal application – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria

Both:

1. Treatment remains clinically appropriate and patient is benefitting from and tolerating treatment; and

2. Pirfenidone is to be discontinued at disease progression (See Notes).

Notes: disease progression is defined as a decline in percent predicted FVC of 10% or more within any 12 month period.

The same restrictions apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List (HML).”2

For more information on the funding or to access the special authority forms, please click here.



Esbriet’s Mechanisms of Action

Esbriet has been shown to:1,3

  • exert anti-fibrotic and anti-inflammatory properties
  • regulate the activity of transforming growth factor (TGF) β and tumour necrosis factor (TNF) α
  • inhibit fibroblast proliferation and collagen synthesis
  • reduce cellular and histological markers of fibrosis
For a quick introduction to some of the patient benefits of Esbriet, please watch this video.




References

  1. Esbriet® (pirfenidone) Data Sheet. Available here
  2. PHARMAC 2017. Application for subsidy by special authority, SA1628. Available at http://www.pharmac.govt.nz/2017/06/01/SA1628.pdf. Accessed 11 January 2017.
  3. Noble PW, Albera C, Bradford WZ, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY); two randomised trails. Lancet 2011;377:1760-69
  4. Noble PW, Albera C, Bradford WZ, et al. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. Eur Respir J 2016;47:27-30
  5. Taniguchi H, Ebina M, Kondoh Y, et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J 2010;35:821-829
  6. Azuma A, Nukiwa T, Tsuboi E, et al. Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2005;171:1040-1047
  7. Noble PW, Albera C, Bradford WZ, et al. Analysis of pooled data from three phase 3, multinational, randomized, double-blind, placebo-controlled trials evaluating pirfenidone in patients with idiopathic pulmonary fibrosis. Poster presented at the American Thoracic Society International Conference, May 16-21, 2014. San Diego, USA. Poster #A11

he registration of Esbriet is based on data from three randomised, double-blind, placebo-controlled Phase III clinical studies ASCEND, CAPACITY 004 and 006. 1-2

In these studies, Esbriet has been shown to (compared to placebo):

  • reduce the risk of mortality at one year by 48%1slow the loss of lung function (as measured by forced vital capacity) by about half (47.9%) at one year1

Esbriet Safety profile

For the full Esbriet safety information, please refer to the Data Sheet available here.4

Esbriet has a well-established safety profile.3 More than 20,000 IPF patients have been treated with Esbriet worldwide.5 Common side effects include nausea, rash, diarrhoea, fatigue, dyspepsia and photosensitivity reaction.3 These are generally mild to moderate in severity and rarely lead to treatment discontinuation.3

  • Comprehensive analysis of five IPF clinical trials demonstrated that Esbriet treatment is generally well-tolerated6
  • Side-effects were generally mild-to-moderate6
    • Gastrointestinal and skin side-effects were manageable and decreased over time.
    • Elevations in liver enzymes were transient, reversible and did not have clinical consequences.

Contraindications

  • Patients with a hypersensitivity to pirfenidone or any of the excipients
  • Patients taking fluvoxamine
  • History of angioedema with pirfenidone

Precautions

Hepatic Function

  • Elevations in ALT and AST 3 x ULN have been reported
  • Liver function tests should be conducted prior to and during treatment
  • If significant elevations occur, the dose of Esbriet should be adjusted; refer to dosage guidelines in Data Sheet.

Photosensitivity reaction/rash

  • Exposure to direct sunlight should be avoided or minimised during treatment and patients instructed to wear sunblock and protective clothing
  • Dosage adjustment or temporary discontinuation may be required; refer to dosage guidelines in Data Sheet.

Cigarette smoking and inducers of CYP1A2

  • Exposure to pirfenidone was 50% less in patients who were smokers
  • Concomitant use of strong inducers of CYP1A2 including smoking should be avoided.

Drug Interactions

  • Esbriet is contraindicated in patients taking fluvoxamine
  • Caution should be taken in patients taking inhibitors of CYP1A2 e.g. ciprofloxacin, amiodarone, propafenone or inducers of CYP1A2 e.g. omeprazole, rifampicin.

Adverse Effects

Very common and common adverse effects only. See Data Sheet for full list.

Infections and infestations: upper respiratory tract infection, urinary tract infection

Metabolism and nutrition disorders: anorexia, weight loss, decreased appetite

Psychiatric disorders: insomnia

Nervous system disorders: headache, dizziness, somnolence, dysgeusia, lethargy

Vascular disorders: hot flush

Respiratory, thoracic and mediastinal disorders: dyspnoea, cough, productive cough

Gastrointestinal disorders: dyspepsia, nausea, diarrhoea, gastroesophageal reflux disease, vomiting, abdominal distension, abdominal pain, gastritis, constipation, flatulence

Hepatobiliary disorders: ALT increased, AST increased, gamma glutamyl transferase increased

Skin and subcutaneous tissue disorders: photosensitivity reaction, rash, pruritus, erythema, dry skin

Musculoskeletal and connective tissue disorders: myalgia, arthralgia

General disorders and administration site conditions: fatigue, asthenia, non-cardiac chest pain

Injury poisoning and procedural complications: sunburn

Please contact the Roche team for further information on the efficacy and/or safety of our products.

References

  1. King TE, Bradford WZ, Castro-Bernardini S, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med 2014;370:2083-2092
  2. Noble PW, Albera C, Bradford WZ, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY); two randomised trails. Lancet 2011;377:1760-69
  3. Noble PW, Albera C, Bradford WZ, et al. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. Eur Respir J 2016;47:27-30
  4. Esbriet® (pirfenidone) Data Sheet. Available here.
  5. Roche Data on File. ESB001
  6. Lancaster L, Albera C, Bradford WZ, et al. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Resp Res 2016;3:e000105. doi:10.1136/bmjresp-2015-000105

Click on the image below to download the Esbriet patient booklet.

Esbriet patient booklet

This booklet is a helpful source of information for patients. It is not meant to substitute any guidance, advice or help provided by their doctor, nurse or pharmacist.

More information for patients on Esbriet can be found in the Consumer Medicine Information (CMI) leaflet, available here.