Enbrel 25mg and 50mg solution for injection in pre-filled syringe

  • Name:

    Enbrel 25mg and 50mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Etanercept

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/19

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Summary of Product Characteristics last updated on medicines.ie: 26/11/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 227 items.Total: Infinity pages

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 November 2019 SmPC

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 PIL

Reasons for updating

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

Updated on 23 April 2019 PIL

Reasons for updating

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

Updated on 23 April 2019 SmPC

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 1 March 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 28 February 2019 SmPC

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 3 August 2018 PIL

Reasons for updating

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

Updated on 3 August 2018 SmPC

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 3 August 2018 SmPC

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 11 May 2018 SmPC

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 10 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 6 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 April 2018 SmPC

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 4 April 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 April 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 February 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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:
Enbrel 25 mg solution for injection in pre-filled syringe and Enbrel 50 mg solution for injection in pre-filled syringe
Section 6.5 – addition of new pack size
Section 8 – addition of MA number for new pack size

Updated on 26 February 2018 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number

Updated on 26 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 February 2018 PIL

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 1 February 2018 SmPC

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

The SPC has been updated as follows: Section 3 – update to the description of the colour of the solutions. Section 6.6 – update to the description of the colour of the solutions.

Updated on 8 December 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change from individual to joint SPC

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.

And 

Combining 25 and 50 mg pre-filled syringe formulations SPC and PIL

Updated on 5 December 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Individual PILs superseded by joint PIL

Updated on 9 June 2017 SmPC

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 7 June 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 27 April 2017 SmPC

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 10

Updated on 24 April 2017 PIL

Reasons for updating

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

Updated on 9 May 2016 SmPC

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 4 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 December 2015 SmPC

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 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 26 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 24 April 2015 SmPC

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 SmPC

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

Update section 4.8 SmPC to align with CDS to introduce viral infections in the list of opportunistic infections.

Updated on 11 August 2014 SmPC

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 4 August 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 23 January 2014 SmPC

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

Update to Section 4.2

Updated on 30 October 2013 SmPC

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 4.4 & 4.8

Updated on 23 October 2013 PIL

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 SmPC

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

Update to section 4.6, Fertility, pregnancy and lactation to add information regarding the placental transfer of etanercept. Enhanced instructions for preparing for an injection using the pre-filled syringe presentations following the introduction of a new packaging design, referred to as a slim-pack design have been added. Minor changes to align with EMA Product Information (PI) QRD templates have also been introduced.

Updated on 23 August 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 2 July 2013 SmPC

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

Update to the description of the liquid solution in the Enbrel pre-filled syringe (PFS) and pre-filled pen (PFP) presentations.

Updated on 28 June 2013 PIL

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 SmPC

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 of the SPC has been updated regarding lactation information

Updated on 27 March 2013 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 1 February 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 January 2013 SmPC

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

Update to section 4.8

Updated on 17 January 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 12 November 2012 SmPC

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

Add scleritis as an adverse drug reaction to section 4.8 of the SPC

Updated on 12 September 2012 SmPC

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 sections 4.4 & 4.8  to supplement the infections information in the special warnings and AE sections regarding listeria, legionella, and parasitic infection, including protozoal infections.

Updated on 13 August 2012 SmPC

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 7 August 2012 PIL

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 17 January 2012 SmPC

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)

Free text change information supplied by the pharmaceutical company

Enbrel 25mg solution for injection in pre-filled syringe – reduction in the number of medi-swabs supplied in pack (section 6.5)

Updated on 13 January 2012 PIL

Reasons for updating

  • Change to packaging

Updated on 25 October 2011 SmPC

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)

Free text change information supplied by the pharmaceutical company

Changes to section 6.4 - Update to allow storage outside of a refrigerator for 4 weeks

Updated on 21 October 2011 PIL

Reasons for updating

  • Change to storage instructions

Updated on 30 September 2011 SmPC

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 4.1:    Extension of polyarticular JIA population to include 2 & 3 year olds. Extension of paediatric psoriasis to include 6 & 7 year olds.
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 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 25 August 2011 SmPC

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

Section 7 Marketing Authorisation Holder now shows Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Updated on 23 August 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 28 July 2011 SmPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 10 June 2011 SmPC

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: Autoimmune hepatitis has been added as a rare undesirable effect under Hepatobiliary disorders

Updated on 10 June 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 31 May 2011 SmPC

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 SPC: Sarcoidosis has been added as a rare undesirable effect under Nervous system disorders.

Updated on 31 May 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 9 March 2011 SmPC

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 SmPC has been updated as follows:
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 8 March 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 15 February 2011 SmPC

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 4.2: Inclusion of “The recommended dose is” under Paediatric populations
Further explanation of dosing in Paediatric populations (in pre-filled syringe and pre-filled pen presentations only)
Section 4.4: Warning of IBD in JIA patients
Section 4.8: Explanation of reports of IBD in JIA patients

Updated on 4 February 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 21 December 2010 SmPC

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)

Free text change information supplied by the pharmaceutical company

SmPC
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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 6 August 2010 SmPC

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)

Free text change information supplied by the pharmaceutical company

Type II variation (EMEA/H/C/262/II/117). Update of section 4.4 and 4.8 of the SPC with information regarding Paediatric Malignancies and Leukaemia. The Patient Information Leaflet is updated accordingly.

Updated on 30 July 2010 PIL

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 5 July 2010 SmPC

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)

Free text change information supplied by the pharmaceutical company

Update of section 4.4 of the SmPC with information regarding reports of hypoglycaemia following initiation of Enbrel in patients receiving medication for diabetes. The Patient Information Leaflet is updated accordingly.

Updated on 5 July 2010 PIL

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 PIL

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 7 January 2010 SmPC

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)

Free text change information supplied by the pharmaceutical company

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 PIL

Reasons for updating

  • Change to storage instructions
  • Change to improve clarity and readability

Updated on 25 August 2009 SmPC

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

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 – 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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 16 July 2009 SmPC

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 4.4 - addition of 'Solid and hematopoietic malignancies'

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 18 May 2009 SmPC

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 18 May 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 5 December 2008 SmPC

Reasons for updating

  • Improved electronic presentation

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Updated on 3 October 2008 SmPC

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 3 October 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 1 August 2008 PIL

Reasons for updating

  • Change to drug interactions
  • Change to dosage and administration

Updated on 1 August 2008 SmPC

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

Section 5.1 – update to ATC code and Clinical Trial data

Updated on 18 December 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 12 December 2007 SmPC

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 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

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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
 

Section 6.3

Increase of shelf life from 18 months to 2 years

Updated on 15 October 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to further information section
  • Change to dosage and administration

Updated on 17 September 2007 SmPC

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

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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

Amendments to Additional Information section to update wording regarding infections

Updated on 16 May 2007 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to further information section

Updated on 25 April 2007 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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Section 6.1
Sodium phosphate monobasic monohydrate changed to:
Sodium phosphate monobasic dihydrate
 
Sodium phosphate dibasic anhydrous changed to:
Sodium phosphate dibasic dihydrate
 
Section 10
Date changed to:
Approved:  2 April 2007
 
EMEA details (below Section 10)
website now reads:
...http://www.emea.europa.eu

Updated on 7 February 2007 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 31 January 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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The following text has changed
 
Section 4.1
 

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.

 
Section 4.8
 

Undesirable effects in adults

 

....

Undesirable effects in adults

 

...
Additionally, Enbrel has been studied in 131240  psoriatic arthritis patients who participated in 2 double-blind placebo‑controlled studies and an open-label extension study.
....

 

Infections

 

....

 

In placebo-controlled psoriatic arthritis trials and plaque psoriasis trials, there were no differences in rates of infection among patients treated with Enbrel and those treated with placebo.  In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia)no serious infections occurred in patients treated with Enbrel.  In the double-blind and open-label plaque psoriasis trials of up to 15 months, serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis and abscess.
....
 
 Section 5.1
 

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.

 
[GRAPH APPEARS]
 

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.

 

Radiographic changes were assessed in the psoriatic arthritis study.  Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.  The modified TSS at 12 months is presented in the Table below.  In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the Enbrel group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).  The effect of Enbrel on radiographic progression was maintained in patients who continued on treatment during the second year.  The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement. 
 

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 14 December 2006 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 14 December 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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The following text has changed in section 4.8
 
 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 1 December 2006 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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Section 4.6 - the addition of the following statement under subheading 'Lactation': 

"Following subcutaneous administration to lactacting rats, etanercept was excreted in the milk and detected in the serum of pups." 

Updated on 10 November 2006 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 November 2006 SmPC

Reasons for updating

  • New SPC for new product

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