Changes to instructions on the administration of EpiPen® and EpiPen® Junior adrenaline autoinjector
IMPORTANT STATEMENT BELOW, PLEASE READ.
Mylan UK has recently received an approval for a variation to the administration of EpiPen® and EpiPen® Junior adrenaline autoinjector. This update is in line with changes in the USA, Australia and some European countries. The changes have been implemented based on post marketing surveillance as well as the results of a review of relevant literature.
There is no change to the device or the drug (adrenaline); the change is in the instructions for use as outlined below:
- Reduced injection time from 10 to 3 seconds – this is based on research confirming delivery of adrenaline for 3 seconds is sufficient.
- Removal of the massage step after the injection – this step has been removed to simplify the process of administering EpiPen® or EpiPen® Junior.
The changes above are aimed to improve patient compliance.
It is important to remember that, the effectiveness of the EpiPen® and EpiPen® Junior will not be impacted regardless of whether it is held for 3 or 10 seconds.
We expect EpiPen® and EpiPen® Junior with the 3 second label to enter pharmacies in the UK from November 2017 onwards. There may still be some EpiPen® and EpiPen® Junior with the 10 second label available on the market.
Patients should be reassured that even if their product indicates it should be used for 10 seconds there will be no detrimental impact if it is only used for 3 seconds.