Fasenra 30 mg solution for injection in pre-filled pen *

Pharmacy Only: Prescription

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

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