Changes to instructions on the administration of EpiPen® and EpiPen® Junior adrenaline autoinjector

Published by the Anaphylaxis Campaign  

https://www.anaphylaxis.org.uk/2017/10/05/changes-instructions-administration-epipen-epipen-junior-adrenaline-autoinjector/

5^th October 2017

The Anaphylaxis Campaign has been contacted by several of our supporters about the changes to instruction of the administration EpiPen® and EpiPen® Junior adrenaline.

We contacted Mylan UK for clarification and they have provided us with a position statement, please below:

Changes to instructions on the administration of EpiPen® and EpiPen® Junior adrenaline autoinjector

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.

The adrenaline injectors prescribed in the UK at present are Emerade®, EpiPen® and Jext®. The Anaphylaxis Campaign has contacted ALK the pharmaceutical company that produces Jext® and Bausch and Lomb who produce Emerade® who have informed us that they have, at present, no plans the change the method of administration of their adrenaline autoinjectors.

 The place where the adrenaline is administered is the same for all three injectors; Emerade®, EpiPen® and Jext® are injected into the muscle in the front quarter of the outer thigh. However, the method of administration for each autoinjector varies slightly. Training should be given to all those who might be required to administer the adrenaline in an emergency, such as family members and friends. You can also find help on the website relevant to the injector you carry. For Emerade® visit www.emerade-bausch.co.uk, for EpiPen® visit www.epipen.co.uk and for Jext® visit www.jext.co.uk.