Fasenra 30 mg solution for injection in pre-filled pen
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
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 05 November 2024
File name
20241024 SPC IE MT Fasenra 30mg PFS PFP EGPA RSP 24 0016.pdf
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- 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 05 November 2024
File name
20241024 Package Leaflet IE MT Fasenra PFP EGPA RSP 24 0015.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
Updated on 25 July 2023
File name
20230720 SPC IE MT Fasenra PFP TATE RSP 23 0008.pdf
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)
Free text change information supplied by the pharmaceutical company
4. CLINICAL PARTICULARS
[..]
4.2 Posology and method of administration
[..]
Paediatric population
The safety and efficacy of Fasenra in children and adolescents aged 6 to 1817 years havehas not been established.
No data are available for children aged 6 to 11 years old. Currently available limited data in children 12 6 to 11 years old and data in adolescents aged 12 to less than 18 years old 17 are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
The safety and efficacy of Fasenra in children less than 6 years have not been established. No data are available.
[..]
4.8 Undesirable effects
[..]
Paediatric population
[..]
In an open-label, uncontrolled pharmacokinetic and pharmacodynamic study of 48 weeks duration in a limited number of paediatric patients (n=28) with uncontrolled severe asthma, the safety profile for patients aged 6 to 11 years old was similar to the adult and adolescent population (see section 4.2).
[..]
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
[..]
Paediatric population
[..]
In an open-label, uncontrolled pharmacokinetic and pharmacodynamic study of 48 weeks duration in a limited number of patients 6 to 11 years (n=28) with uncontrolled severe asthma, the magnitude of blood eosinophil depletion was similar to adults and adolescents.
No conclusion can be drawn regarding asthma efficacy in the paediatric population (see section 4.2).
[..]
5.2 Pharmacokinetic properties
[..]
Special populations
[..]
Paediatric population
Based on the population pharmacokinetic analysis and clinical study data, the pharmacokinetics of benralizumab in children and adolescents aged 12 6 to 17 years were consistent with adults after accounting for bodyweight as applicable Benralizumab has not been studied in children (5 to 11 years old) (see section 4.2).
Updated on 06 June 2023
File name
20230518 SPC IE MT Fasenra PFP Postcode Update RSP 23 0005.pdf
Reasons for updating
- 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 06 June 2023
File name
20230518 Package Leaflet IE MT Fasenra PFP Postcode Update RSP 23 0004.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 September 2022
File name
20220915 Package Leaflet IE MT Fasenra PFP Licence Renewal 2022 RSP 22 0004.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
20220915 SPC IE MT Fasenra PFP Licence Renewal 2022 RSP 22 0003.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
20220519 SPC IE MT Fasenra PFP PONENTE CT Update RSP 22 0001.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
20220519 Package Leaflet IE MT Fasenra PFP PONENTE CT Update RSP 22 0002.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.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.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.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.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
Updated on 21 April 2020
File name
20190627-uim-spc-Fasenra-PFS SA and AI-RSP 19 0039.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.pdf
Reasons for updating
- New PIL for new product