Esbriet 267 mg, 534 mg and 801 mg Film-coated Tablets

Product Information *

  • Company:

    Roche Registration GmbH
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 26 July 2021

File name

ESB_SmPC_II-0070_10Jun2021_clean_1627308946.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 July 2021

File name

ESB_PIL_II-0070_10Jun2021_clean_1627308884.pdf

Reasons for updating

  • New PIL for new product

EDM Updated on 25 November 2020

File name

Esbriet HCP Checklist IE Version 10.2.0_1606305521.pdf

Reasons for updating

  • Add New Doc

Updated on 24 November 2020

File name

ESB_SmPC_tabs_II66G_dated 16Nov2020_clean_1606214758.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 January 2020

File name

Esbriet tabs SmPC 09 Jan 2020_clean_1579526797.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 November 2019

File name

Esbriet_tabs_SmPC_PSUSA_11Nov2019_clean _1574351195.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 November 2019

File name

Esbriet_tabs_PIL_PSUSA__11Nov2019_clean_1574351136.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 September 2019

File name

PI2018-141402_Esbriet tabs SmPC_1569320431.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 August 2019

File name

Esbriet PIL dated March 2019_clean_1566376885.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 April 2019

File name

uk-ie-mt-pil-Esbriet-clean-190321-267mg-534mg-801mg-tabs_1554483386.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 17 August 2018

File name

uk-ie-mt-pil-Esbriet-clean-180809-267-534-801-tabs_1534505048.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 29 May 2018

File name

uk-ie-mt-spc-Esbriet-clean-180417-267-534-801-tabs.docx

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Additional pack sizes bottles

Updated on 29 May 2018

File name

uk-ie-mt-pil-Esbriet-clean-180417-267-534-801-tabs.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 22 May 2018

File name

uk-ie-mt-spc-Esbriet-clean-180404-267-534-801-tabs.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

MAH transfer to Roche Registration GmbH

Updated on 23 April 2018

File name

uk-ie-mt-pil-Esbriet-clean-180404-267-534-801-tabs.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 February 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 February 2018

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle:

​​

This medicinal product is subject to additional monitoring.  This will allow quick indentification of new safety information.  Healthcare professionals are asked to report any suspected adverse reactions.  See section 4.8 for how to report adverse reactions.

​​

​​

10.    Date of Revision of the Text

​​

08 February 2018

Updated on 14 February 2018

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of black triangle

Updated on 14 February 2018

File name

PIL_17195_166.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 December 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 

[ … ]

 

Renal impairment 

No dose adjustment is necessary in patients with mild to moderate renal impairment. Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment. Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2). 

 

[ … ]

 

4.3     Contraindications

 

[ … ]

          Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see             sections 4.2 and 5.2 4.4).

 

 

 

4.8       Undesirable effects

 

[ … ]

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see details below).

 

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

 

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

 

 

 

 

5.2     Pharmacokinetic properties

 

[ … ]

 

Biotransformation

 

Approximately 70–80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1. In vitro and in vivo studies to datae have not detected any indicate some pharmacologically relevant activity of the major metabolite (5‑carboxy-pirfenidone), even  at concentrations or doses greatly above those associated with activity of pirfenidone itsel in excess of peak plasma concentrations in IPF patients. This may become clinically relevant in patients with moderate renal impairment where plasma exposure to 5‑carboxy-pirfenidone is increased f.

 

[ … ]

 

Renal impairment

 

No clinically relevant differences in the pharmacokinetics of pirfenidone were observed in subjects with mild to severe renal impairment compared with subjects with normal renal function. The parent substance is predominantly metabolised to 5‑carboxy-pirfenidone,.  The mean (SD) AUC0-∞ of 5-carboxy-pirfenidone was significantly higher in the moderate (p = 0.009) and severe (p < 0.0001) renal impairment groups than in the group with normal renal function; 100 (26.3) mg•h/L and 168 (67.4) mg•h/L compared to 28.7 (4.99) mg•h/L respectively. and the pharmacokinetics of this metabolite is altered in subjects with moderate to severe renal impairment.

Renal Impairment Group

 

Statistics

AUC0-(mg•hr/L)

Pirfenidone

5-Carboxy-Pirfenidone

Normal

Mean (SD)

42.6 (17.9)

28.7 (4.99)

n = 6

Median (25th–75th)

42.0 (33.1–55.6)

30.8 (24.1–32.1)

Mild

Mean (SD)

59.1 (21.5)

49.3a (14.6)

n = 6

Median (25th–75th)

51.6 (43.7–80.3)

43.0 (38.8–56.8)

Moderate

Mean (SD)

63.5 (19.5)

100b (26.3)

n = 6

Median (25th–75th)

66.7 (47.7–76.7)

96.3 (75.2–123)

Severe

Mean (SD)

46.7 (10.9)

168c (67.4)

n = 6

Median (25th–75th)

49.4 (40.7–55.8)

150 (123–248)

 

AUC0-∞  = area under the concentration-time curve from time zero to infinity.

a p-value versus Normal = 1.00 (pair-wise comparison with Bonferroni)

b p-value versus Normal = 0.009 (pair-wise comparison with Bonferroni)

c p-value versus Normal < 0.0001 (pair-wise comparison with Bonferroni) AUC0- = area under the concentration-time curve from time zero to infinity

 

 

However, the predicted amount of metabolite accumulation at steady state is not pharmacodynamically important because the terminal elimination half‑life is only 1–2 hours in these subjects. Exposure to 5-carboxy-pirfenidone increases 3.5 fold or more in patients with moderate renal impairment. Clinically relevant pharmacodynamic activity of the metabolite in patients with moderate renal impairment cannot be excluded. No dose adjustment is required in patients with mild to moderate renal impairment who are receiving pirfenidone.  Pirfenidone should be used with caution in patients with moderate renal impairment.  The use of pirfenidone is contraindicated in patients with severe renal impairment (CrCl <30ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 4.3).

 

[ … ]

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

08 December 2017

 

Updated on 15 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 28 June 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 June 2017

Reasons for updating

  • New PIL for new product