Esbriet Film-coated Tablets
*Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 March 2024
File name
Esbriet Tabs PIL_IAIN_06 Mar 2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 13 March 2024
File name
Esbriet Tabs SmPC_IAIN_06 Mar 2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 April 2023
File name
Esbriet FCT PIL dated 24 Mar 2023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 13 April 2023
File name
Esbriet FCT SmPC dated 24 Mar 2023.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 29 July 2022
File name
Esbriet Tabs PIL dated Jul 2022.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 29 July 2022
File name
Esbriet Tabs SmPC dated 22Jul2022.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 June 2022
File name
267_534_801mg FCT_PIL Clean_Jun 2022.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 16 December 2021
File name
ESB_tabs_PSUSA_SmPC_09Dec2021_Clean.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 16 December 2021
File name
ESB_tabs_PSUSA_PIL_09Dec2021_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 08 September 2021
File name
ESB_PIL_II-0070_10Jun2021_v2_clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 26 July 2021
File name
ESB_SmPC_II-0070_10Jun2021_clean.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.pdf
Reasons for updating
- New PIL for new product
File name
Esbriet HCP Checklist IE Version 10.2.0.pdf
Reasons for updating
- Add New Doc
Updated on 24 November 2020
File name
ESB_SmPC_tabs_II66G_dated 16Nov2020_clean.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.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 .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.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.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.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.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.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
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
File name
PIL_17195_166.pdf
Reasons for updating
- New PIL for new product
Updated on 14 February 2018
Reasons for updating
- Change to section 6 - date of revision
- Removal of black triangle
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
Updated on 27 June 2017
Reasons for updating
- New PIL for new product