Fasenra 30 mg solution for injection in pre-filled pen *
Pharmacy Only: Prescription

EDM Updated on 27 September 2022

File name

6332bea654568.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Revisions have been made as a result of EU License Renewal, summarised below (added text in bold, deleted text in strike through)

Minor administrative changes throughout

Step 2 - Prepare to use your pre filled syringe

Prior to administration, allow the pre-filled syringe to reach Let Fasenra warm up at room temperature 20°C to 25°C by leaving the carton out of the refrigerator for about 30 minutes before giving the injection.


Instructions for Use was last approved in 09/2022

Updated on 27 September 2022

File name

6332bc8adb06b.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Revisions have been made as a result of the EU License Renewal. Summary of the changes below (added text in bold, deleted text in strike through):

 

Removal of black triangle and associated text

Minor administrative changes throughout

 

1. What Fasenra is and what it is used for  

Eosinophils are white blood cells involved in asthma inflammation. By attaching to the eosinophils, Fasenra helps to reduce their numbers and inflammation.

 

2. What you need to know before you use Fasenra

Warnings and precautions

Talk to your doctor, nurse (…) patients receiving this medicine.

Fasenra is not a rescue medicine. Do not use it to treat a sudden asthma attack.

Children and adolescents

Do not give this medicine to children below the age of 18 because tThe safety and benefits of this medicine are not known in children below the age of 18 this population.

 

3. How to use Fasenra

You or your caregiver should receive training on the right way to prepare and inject Fasenra. Read the ‘Instructions for Use’ for the pre filled syringe carefully before using Fasenra.

 

4. Possible side effects

  • hypersensitivity reactions (hives,
  • rash)

 

5. How to store Fasenra

Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP’.

The syringe may be kept at room temperature up to 25°C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded., and the discard date should be written on the carton.

 

6.0

This leaflet was last revised in 09/2022

Updated on 26 September 2022

File name

6331d1e1363c9.pdf

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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Multiple revisions made to the Fasenra SmPC as a result of the EU License Renewal.

Updated on 24 May 2022

File name

628cc37fa3f36.pdf

Reasons for updating

  • 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

Change to section 5.1 Pharmacodynamic properties - Clinical efficacy:

Inclusion of data from PONENTE study.

Change to section 10. Date of revision of the text:

Revision date updated to 19 May 2022.

Updated on 24 May 2022

File name

628cc1bc90f7a.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Minor editorial update to section 2. What you need to know before you use Fasenra - Other medicines for asthma:

Other medicines for asthma

Do not suddenly stop taking or change the dose of your preventer medicines for your asthma once you have started Fasenra.


Change to section 6. Content of the pack and other information:

Revision date updated to 05/2022

Updated on 16 December 2021

File name

20211209 Package Leaflet IE MT Fasenra PFP MELTEMI 2 Update RSP 21 0014_1639651858.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 16 December 2021

File name

20211209 SPC IE MT Fasenra PFS and PFP MELTEMI 2 Update RSP 21 0013_1639651653.pdf

Reasons for updating

  • 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)

Updated on 15 July 2021

File name

20210708 SPC IE MT Fasenra PFS and PFP MELTEMI Update RSP 21 0008_1626348519.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 31 March 2021

File name

20210326 Package Leaflet IE MT Fasenra PFP 30 mg Nijmegen Change RSP 21 0004_1617204157.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

EDM Updated on 21 April 2020

File name

20190627-uim-ifu-Fasenra-AI only-RSP 19 0041_1587458441.pdf

Reasons for updating

  • Add New Doc

Updated on 21 April 2020

File name

20190627-uim-spc-Fasenra-PFS SA and AI-RSP 19 0039_1587458295.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 21 April 2020

File name

20190627-uim-pl-Fasenra-AI only-RSP 19 0038_1587458049.pdf

Reasons for updating

  • New PIL for new product