Jext® Extended Use Beyond Labelled Expiry Date for Selected Lots
To ease the current shortage of adrenaline auto injectors, ALK has obtained acceptance from the MHRA to extend the use of specific lot (batch) numbers of Jext® 150 mcg and Jext® 300 mcg autoinjectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below and are also available on www.jext.co.uk.
Important: the extended use only applies to the lots of Jext® 150 mcg and Jext® 300 mcg autoinjectors listed above. Patients can continue to use the Jext® auto-injectors of these specified lots safely until the extended use by date as stated above.
This extended use does not apply to any other lot number of Jext® auto injectors not specified. Patients must continue to adhere to the labelled expiry date on any Jext® auto injector not covered by the lot numbers above.
Further information on the extended use of the listed lots of Jext® auto injectors
There is currently a shortage of adrenaline auto-injectors in the UK. This shortage has been caused by intermittent supply issues of the most commonly prescribed brand and is affecting most countries in Europe. It is anticipated that supply will stabilise in the fourth quarter (October to December) of 2018. The supply status will be continuously reviewed by the Department of Health and Social Care.
ALK is working hard to help address the situation and has significantly increased production of its Jext® 150 mcg and 300 mcg adrenaline auto-injectors at its European manufacturing facility. Howev-er, due to the time needed for manufacture and the magnitude of the current deficit, it is not possible for ALK to completely meet the shortfall in supply in the short term.
To further ease the shortfall, the period that 32 specific lots of Jext® 150 mcg and Jext® 300 auto-injectors (listed above) can be used has been extended by 4 months beyond the labelled expiry date on the pack. Lot numbers and labelled expiry dates are marked on the side of the box and on the auto injector label itself.
This extended use of 4 months beyond the labelled expiry date for the specific lots is based on supportive stability data for Jext® auto injectors and has been reviewed by the MHRA. The Jext® auto injectors of these specific lots will continue to work safely and as intended within the allowed extended use by date. The Jext® auto injectors should continue to be stored as labelled on the pack.
At the end of the extended use period (the end of the month listed in the right column of the table above), a new auto injector will still need to be obtained.