Eylea 40 mg/mL solution for injection in pre-filled syringe

  • Name:

    Eylea 40 mg/mL solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Aflibercept

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/03/21

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Summary of Product Characteristics last updated on medicines.ie: 3/3/2021

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Bayer Limited

Bayer Limited

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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 3 March 2021 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

 

Reason for Change

  • To introduce ARIES data in the Eylea pre filled syringe PIL (section 3) to allow a more frequent than Q8 treatment for the wAMD indication for a sub-group of patients that might need it.

3. How you will be given Eylea

[…]

wet AMD

[…]

If your condition worsens, the interval between injections can be shortened, but to not less than every two months in the first year of treatment.

[…]

6. Contents of the pack and other information

[…]

This leaflet was last revised in 01/2021

 

 

 

 

Updated on 3 March 2021 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Reason for Change

  • To introduce ARIES data in the Eylea pre-filled syringe SmPC (section 4.2 and 5.1) to allow a more frequent than Q8 treatment for the wAMD indication for a sub-group of patients that might need it.

 

4.2 Posology and method of administration

[…]

Posology

wet AMD

[…]

If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly to a minimum of two months during the first 12 months of treatment.

 

[…]

 

Treatment intervals greater than four months or shorter than 4 weeks between injections have not been studied (see Section 5.1).

 

[…]

5.1 Pharmacodynamic properties

[…]

Pharmacodynamic effects

wet AMD

[…]

The ARIES study was designed to explore the non-inferiority of an Eylea 2 mg treat-and-extend dosing regimen initiated immediately after administration of 3 initial monthly injections and one additional injection after 2 months vs. a treat-and-extend dosing regimen initiated after one year of treatment. For patients requiring a more frequent than Q8 dosing at least once over the course of the study, CRT remained higher, but the mean decrease in CRT from baseline to week 104 was -160.4 microns, similar to the patients treated at Q8 or less frequent intervals.

 

[…]

Clinical efficacy and safety

wet AMD

[…]

ARIES was a 104-week multicentre, randomised, open-label, active-controlled study in 269 patients with treatment naïve wet AMD, designed to assess the non-inferiority in terms of efficacy as well as the safety of a treat-and-extend dosing regimen initiated after 3 consecutive monthly doses followed by extension to a 2 monthly treatment interval vs. a treat-and-extend dosing regimen initiated after the first year of treatment.

The ARIES study also explored the percentage of patients that required more frequent treatment than every 8 weeks based on the investigator’s decision. Out of the 269 patients 62 patients received more frequent dosing at least once during the course of the study. Such patients remained in the study and received treatment according to the investigator’s best clinical judgement but not more frequently than every 4 weeks and their treatment intervals could be extended again afterwards. The average treatment interval after the decision to treat more frequently was 6.1 weeks. Week 104 BCVA was lower in patients requiring more intensive treatment at least once over the course of the study compared with patients who did not and the mean change in BCVA from baseline to end of the study was +2.3 ± 15.6 letters. Among the patients treated more frequently, 85.5% maintained vision, i.e. lost less than15 letters, and 19.4% gained 15 letters or more. The safety profile of patients treated more frequently than every 8 weeks was comparable to the safety data in VIEW 1 and VIEW 2.

 

[…]

10. DATE OF REVISION OF THE TEXT

January 2021

 

Updated on 15 January 2021 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 15 January 2021 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 15 January 2021 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 15 January 2021 PIL

Reasons for updating

  • New PIL for new product