4.         CLINICAL PARTICULARS

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4.2       Posology and method of administration

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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.

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4.8       Undesirable effects

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Paediatric population

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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).

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5.         PHARMACOLOGICAL PROPERTIES

5.1       Pharmacodynamic properties

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Paediatric population

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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).

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5.2       Pharmacokinetic properties

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Special populations

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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).

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

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

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.

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