ENBREL 25 mg powder and solvent for solution for injection.
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 17 April 2024
File name
Adv PIL EN 37_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 April 2024
File name
Adv SPC EN 44_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2023
File name
AdvSPCEN43125mgLyoIEclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC IE and SPC NI has been updated as follows:
Section 4.8 of the SPC was updated with glomerulonephritis with the frequency >not known<.
Updated on 20 December 2023
File name
AdvPILEN36125mgLyoIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 November 2023
File name
Adv SPC EN 42_0 25mg Lyo IE clean.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 November 2023
File name
Adv PIL EN 35_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 November 2023
File name
Adv PIL EN 35_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 November 2023
File name
Adv PIL EN 35_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 November 2023
File name
Adv PIL EN 35_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 November 2023
File name
Adv PIL EN 35_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 07 November 2023
File name
AdvSPCEN43025mgLyoIEclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 of the SPC was updated with glomerulonephritis with the frequency >not known<.
Updated on 07 November 2023
File name
AdvPILEN36025mgLyoIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
AdvPILEN36025mgLyoIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 October 2023
File name
Adv SPC EN 42_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 October 2023
File name
Adv PIL EN 35_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 15 August 2023
File name
Adv SPC EN 410 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2023
File name
Adv PIL EN 340 25mg Lyo IE NI clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to information for healthcare professionals
Updated on 16 January 2023
File name
Adv SPC EN 40_0 25mg Lyo IE clean.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 21 June 2022
File name
AdvSPCEN38025mgLyoIEclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 with final results obtained from the clinical paediatric study B1801023 (CLIPPER 2).
Updated on 12 November 2021
File name
Adv PIL EN 33_0 25mg Lyo IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 02 June 2021
File name
DEC202136258_Adv SPC EN 38_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Section 4.2 Detailed instructions on unintentional dosing or scheduling variations, including missed doses to refer to the PIL |
Updated on 30 March 2021
File name
DEC202121880_Adv SPC EN 37_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2021
File name
DEC202121880_Adv PIL EN 32_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 January 2021
File name
DEC202104817_Adv SPC EN 36_0 25mg Lyo IE clean.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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 4.8 addition of headache as an ADR with a frequency of very common. Section 4.4 and 4.8 removal of text regarding IBD in JIA patients
Updated on 26 January 2021
File name
DEC202104817_Adv PIL EN 31_0 25mg Lyo IE 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 section 6 - date of revision
Updated on 14 September 2020
File name
DEC202060602_Adv SPC EN 35_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 September 2020
File name
DEC202060602_Adv PIL EN 30_0 25mg Lyo IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 July 2020
File name
DEC202045193_Adv SPC EN 33_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 4.2 and 4.4 have been updated to refmove the work Alert from Patient Alert Card.
Updated on 03 July 2020
File name
DEC202045193_Adv PIL EN 28_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 26 November 2019
File name
DEC201965747_Adv SPC EN 32_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 4.8 Addition of adverse reaction for Inflammatory bowel disease. Package Leaflet:
Updated on 26 November 2019
File name
DEC201965747_Adv PIL EN 27_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 April 2019
File name
DEC201920929_Adv PIL EN 26_0 25mg Lyo UK_IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 April 2019
File name
DEC201920929_Adv SPC EN 31_0 25mg Lyo UK_IE.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 4.8 addition of PRAC class labelling for Lichenoid Reactions
Updated on 01 March 2019
File name
Adv PIL EN 25_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 28 February 2019
File name
Adv SPC EN 30_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6 addition of most up-to-date information on the safe and effective use of etanercept during pregnancy.
Updated on 03 August 2018
File name
Adv PIL EN 24_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 August 2018
File name
Adv SPC EN 29_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 7 Name and address of MAH changed from Pfizer UK to Pfizer Belgium.
Updated on 13 May 2018
File name
Adv PIL EN 23_0 25mg Lyo UK_IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 11 May 2018
File name
Adv_SPC_EN_28_0_25mg_Lyo_UK_IE_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 May 2018
File name
Adv_SPC_EN_28_0_25mg_Lyo_UK_IE_clean.docx
Reasons for updating
- 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
The SPC has been updated as follows: Date of approval, PfLEET number and internal revision number only
Updated on 06 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2018
Reasons for updating
- 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
Updated on 04 April 2018
File name
PIL_7725_567.pdf
Reasons for updating
- New PIL for new product
Updated on 04 April 2018
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 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 28 February 2018
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Internal revision number only
Updated on 26 February 2018
File name
PIL_7725_962.pdf
Reasons for updating
- New PIL for new product
Updated on 26 February 2018
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation number
Updated on 05 February 2018
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 02 February 2018
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 December 2017
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)
Free text change information supplied by the pharmaceutical company
The frequencies for the ADRs were re-assessed based on a query from a health authority in a PSUR assessment regarding the frequency categories of etanercept ADRs. Due to the reassessment, some ADRs frequencies have been updated and 3 additional are added. Information on 2 ADRs for which there are notable differences observed in the frequencies between the etanercept only and etanercept plus concomitant methotrexate treatment groups is added.
Updated on 05 December 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 09 June 2017
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)
Free text change information supplied by the pharmaceutical company
Type II Variation update to Section 4.8 ‘Undesirable Effects’ of the SPC in order to change the frequency category of the ADR ‘elevated liver enzymes’ from ‘rare’ to ‘uncommon’ and to add some further details on the frequency of elevated liver enzymes reported with etanercept in double-blind controlled trials with or without concomitant methotrexate use. The Package Leaflet (Section 4) was updated accordingly.
In addition, Pfizer took the opportunity to update Section 4.4 of the SPC to add a statement on traceability of biological medicinal products as requested by the PRAC, to make a small correction in Section 6 of the 50 mg solution for injection in a pre-filled pen Package Leaflet ( EU / 1 / 99 / 126 / 0019-021), and to bring the PI in line with the latest QRD template version 10 (i.e. include the unique identifiers in sections 17 and 18 of Annex IIIA).Updated on 07 June 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 27 April 2017
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)
Free text change information supplied by the pharmaceutical company
Update to Section 4.8 ‘Undesirable Effects’ of the SPC in order to change the frequency category of the ADR ‘elevated liver enzymes’ from ‘rare’ to ‘uncommon’ and to add some further details on the frequency of elevated liver enzymes reported with etanercept in double-blind controlled trials with or without concomitant methotrexate use. The Package Leaflet (Section 4) was updated accordingly.
In addition, Pfizer took the opportunity to update Section 4.4 of the SPC to add a statement on traceability of biological medicinal products as requested by the PRAC, to make a small correction in Section 6 of the 50 mg solution for injection in a pre-filled pen Package Leaflet ( EU / 1 / 99 / 126 / 0019-021), and to bring the PI in line with the latest QRD template version 10Updated on 24 April 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 May 2016
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
EU EN 043 is an update to Section 5.1 of the SmPC to add efficacy and safety information to reflect the final 2-year data from study B181031 (non-radiographic axial spondyloarthritis study).
EU EN 051 updates to Section 4.4 of the SmPC to include information on new onset congestive heart failure (CHF), including CHF in patients without known pre-existing cardiovascular disease, and Section 4.8 to amend the term ‘worsening of congestive heart failure’ to ‘congestive heart failure’Updated on 04 May 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 24 December 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.6 of the SmPC and Section 2 of the PIL have been updated to include the information on the effects of etanercept on pregnancy to reflect the final report of the OTIS registry.Updated on 18 December 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 26 June 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 24 April 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: The 10-year efficacy data in rheumatoid arthritis (RA) has been added in the clinical trials section 5.1 of the Summary of Product Characteristics (SmPC).
Updated on 27 October 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 August 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Free text change information supplied by the pharmaceutical company
Updates to sections 4.1, 4.2, 4.8, 5.1 & 10
Updated on 04 August 2014
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
Updated on 30 October 2013
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)
Free text change information supplied by the pharmaceutical company
Updated on 23 October 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to marketing authorisation holder
Updated on 29 August 2013
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 03 July 2013
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 28 June 2013
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Change to appearance of the medicine
- Change to MA holder contact details
- Change to improve clarity and readability
Updated on 27 March 2013
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
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 March 2013
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 24 January 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 January 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 November 2012
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2012
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)
Free text change information supplied by the pharmaceutical company
Updated on 13 August 2012
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Sections 4.1 - 4.5, 4.8, 5.1, 5.2, 10: Extension the indication for juvenile idiopathic arthritis (JIA) to include three new subtypes of the disease and to include long-term safety information for the JIA population, together with reclassification of the licensed indication of polyarticular JIA into the International League of Associations for Rheumatology (ILAR) classification of polyarthritis (rheumatoid factor positive) and polyarthritis (rheumatoid factor negative). Furthermore, an additional etanercept dosage regimen of 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly is proposed in addition to the current approved JIA dosage of 0.4 mg/kg (up to a maximum of 25 mg per dose) twice weekly for the treatment of JIA
Updated on 07 August 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 25 October 2011
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 21 October 2011
Reasons for updating
- Change to storage instructions
Updated on 29 September 2011
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2: Update to paediatric population information.
Section 5.1: Update to Clinical efficacy and safety information. Update to paediatric population information.
Section 6.3: Update to shelf life information
Section 6.4: Update to storage information
Updated on 23 September 2011
Reasons for updating
- Changes to therapeutic indications
Updated on 25 August 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2011
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 26 July 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 has been updated to add systemic vasculitis as a rare side-effect.
Updated on 22 July 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 10 June 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 June 2011
Reasons for updating
- Change to side-effects
Updated on 01 June 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 31 May 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 09 March 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The introduction to the section has been completely revised to bring it more in line with the SPC guideline, highlighting the most common and the most serious AEs, providing the new prescriber with a succinct summary of the AE profile.
The system organ classification (SOC) has been re-ordered, consistent with the SPC guideline
The subsection to the table entitled ‘Serious adverse events reported in clinical trials’ has been deleted.
Updated on 08 March 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 14 February 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.8: Explanation of reports of IBD in JIA patients
Updated on 04 February 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 20 December 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
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4.4: Updates regarding melanoma, merkel cell carcinoma & demyelination
Addition of precaution on use in Elderley (65 yrs and older)
4.8: Addition of melanoma, merkel cell carcinoma
6.3: Increase in shelf life from 2 years to 30 months (PFP & PFS SmPCs only)
(6.6: An error was found in Section 6.6 of the Enbrel 25mg/ml powder and solvent for solution for injection for paediatric use SPC, therefore it has been corrected here)
Updated on 16 December 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 03 August 2010
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)
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Updated on 30 July 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
- Correction of spelling/typing errors
Updated on 05 July 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 05 July 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to MA holder contact details
Updated on 18 January 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to MA holder contact details
Updated on 07 January 2010
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 3: Pharmaceutical form expanded
Section 4.2: Updated with “Enbrel is administered by subcutaneous injection”
Section 4.4: Updated with “The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.” In the infections information
Section 4.4: Updated with “Enbrel should be used with caution in patients with a history of hepatitis C.” in the Hepatitis C information
Section 4.4: Updated with “The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.” in the Combination Therapy information
Section 4.5: Updated with “Physicians should use caution when considering combination therapy with sulfasalazine.” in the Concurrent treatment with sulfasalazine information
Section 4.8: addition of “† Please see sub-section ‘Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis’ above.” In General disorders and administration site conditions information
Section 4.8: Update to information in Concurrent treatment with anakinra information.
Section 5.1: Update to description of Pharmacotherapeutic group
Section 5.2: Expansion of abbreviation - Enzyme-Linked Immunosorbent Assay (ELISA)
Section 6.1: Addition of E number for Mannitol
Section 6.3: Addition of information on in use shelf life
Section 6.6: Addition of “Any unused product or waste material should be disposed of in accordance with local requirements.”
Section 9: Update to date of last renewal
Updated on 26 August 2009
Reasons for updating
- Change to improve clarity and readability
Updated on 25 August 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
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Section 4.2 – addition of Continuous therapy beyond 24 weeks may be appropriate for some patients. To Plaque Psoriasis section
Section 4.8 – addition of details from 5th double blind clinical trial and update to other clinical trial information
Section 5.1 – addition of “An analysis of clinical trial data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option (intermittent or continuous). Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs.”
Section 5.1 – addition of “In long-term (up to 34 months) open-label studies where Enbrel was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.” To Adults with plaque psoriasis section
Updated on 17 July 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 16 July 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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Section 4.8 - addition of 'Non-melanoma skin cancer (NMSC) Non-melanoma skin cancer has been reported in patients treated with TNF-antagonists, including Enbrel. Combining the results of controlled portions of clinical trials of Enbrel, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis. Periodic skin examination is recommended for all patients who are at increased risk for NMSC'
Updated on 10 June 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 May 2009
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
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Section 4.1 - Addition of paediatric psoriasis indication, i.e. the following wording
“Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies”
Several changes relating to this and the studies conducted are contained throughout the SPC
Section 4.4 – update with information on opportunistic infections
Section 4.8 - update with information on opportunistic infections
Updated on 05 December 2008
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 October 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
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Section 4.8
Addition of ‘not known (could not be accurately estimated through clinical studies).’ to headings of frequency.
Addition of ‘Not known: Macrophage activation syndrome*, anti-neutrophilic cytoplasmic antibody positive vasculitis’ to Immune system disorders.
Addition of text to ‘Skin and subcutaneous tissue disorders’
Common: Pruritus
Uncommon: Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset and pustular, primarily palms & soles)
Rare: Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme
Very rare: Toxic epidermal necrolysis
Addition of text - There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Section 6.3
Rewording of text.Updated on 03 October 2008
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 01 August 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
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Section 4.2 – update to dosage for Plaque psoriasis
Section 4.8 – update to Clinical Trial data
Updated on 01 August 2008
Reasons for updating
- Change to dosage and administration
- Change to drug interactions
Updated on 20 December 2007
Reasons for updating
- Change to side-effects
Updated on 12 December 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
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Section 4.4 and Section 4.5
Addition in both sections for statement regarding interaction with abatacept
Section 4.8
Addition of Interstitial lung disease as an undesirable effect
Section 5.1
Update to the ‘Antibodies to Enbrel’ section
Updated on 15 October 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to dosage and administration
Updated on 17 September 2007
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
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Section 4.2
Addition of wording for a Patient Alert Card
Section 4.4
Addition of warnings to the SPC regarding the evaluation of patients for infections before, during and after Enbrel use, screening for TB, what action to take should TB infection be found, the risk of reactivation of hepatitis B virus, and the worsening of hepatitis C
Section 4.5
Update to the interations section of the EU Enbrel SPC to include a statement relating to an absence of interaction between etanercept and either digoxin or warfarin
Section 4.8
Section 10
Updated website address for EMEA
Updated on 07 February 2007
Reasons for updating
- Changes to therapeutic indications
Updated on 31 January 2007
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.
Undesirable effects in adults
Undesirable effects in adults
Additionally, Enbrel has been studied in
Infections
....
Adults with psoriatic arthritis
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis. Patients were between 18 and 70 years of age and had active psoriatic arthritis (³ 3 swollen joints and ³ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis. Patients also had plaque psoriasis with a qualifying target lesion ³ 2 cm in diameter. Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%). Patients currently on methotrexate therapy (stable for ³ 2 months) could continue at a stable dose of £ 25 mg/week methotrexate. Doses of 25 mg Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months. At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
Clinical responsesThe results were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC). Results are summarised in the Table below.
Among patients with psoriatic arthritis who received Enbrel, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy. Enbrel was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy. Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ. The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p < 0.001). There is insufficient evidence of the efficacy of Enbrel in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
|
Mean (SE) Annualized Change From Baseline in Total Sharp Score |
||
|
|
Placebo |
Etanercept |
|
Time |
(n = 104) |
(n = 101) |
|
Month 12 |
1.00 (0.29) |
‑0.03 (0.09)a |
|
SE = standard error. a. p = 0.0001. |
||
Enbrel treatment resulted in improvement in physical function during the double‑blind period, and this benefit was maintained during the longer‑term exposure of up to 2 years.
There is insufficient evidence of the efficacy of Enbrel in patients with ankylosing spondylitis‑like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Updated on 18 December 2006
Reasons for updating
- Change to dosage and administration
Updated on 13 December 2006
Reasons for updating
- Change to section 4.8 - Undesirable effects
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Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Differences from adults and other special considerations are discussed in the following paragraphs.
The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations. Severe adverse events reported in a trial in 69 juvenile idiopathic arthritis patients aged 4 to 17 years included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, Forty-three43 of 69 (62%) children with juvenile idiopathic arthritis experienced an infection while receiving Enbrel during 3 months of the study (part 1 open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy. The types of infections reported in juvenile idiopathic arthritis patients were generally mild and consistent with those commonly seen in outpatient paediatric populations. The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild. Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the 349 adult rheumatoid arthritis patients. These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Updated on 01 December 2006
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
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"Following subcutaneous administration to lactacting rats, etanercept was excreted in the milk and detected in the serum of pups."
Updated on 27 October 2006
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
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Updated on 27 October 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to dosage and administration
- Change to storage instructions
Updated on 24 July 2006
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 July 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
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Updated on 13 July 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to dosage and administration
- Change to date of revision
Updated on 27 September 2005
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 27 September 2005
Reasons for updating
- Change of manufacturer
- Change to, or new use for medicine
Updated on 09 May 2005
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 09 May 2005
Reasons for updating
- Change to information about driving or using machinery
- Change to storage instructions
- Change to further information section
- Change to appearance of the medicine
- Change to dosage and administration
Updated on 08 December 2004
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 December 2004
Reasons for updating
- Change to, or new use for medicine
- Change to drug interactions
Updated on 25 October 2004
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 03 June 2004
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 January 2004
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2003
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 16 June 2003
Reasons for updating
- New SPC for medicines.ie
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