As you are probably aware there is currently a shortage of adrenaline auto-injectors in the UK. This shortage has been caused by intermittent supply issues of another adrenaline device 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. However, 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.
ALK is working closely with its UK distribution partner Alliance Healthcare to ensure equitable distribution of supplies but it is likely that Jext® 150 mcg and Jext® 300 mcg will not be available at all times.
To further ease the situation, ALK has obtained acceptance from the UK medicines regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), to extend the use of specific lot (batch) numbers of Jext® 150 mcg and Jext® 300 mcg auto-injectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.
Table 1 Affected lots (batches) for extended use of Jext® auto-injectors
|No.||Strength, mcg||Lot (batch) no.||Labelled Expiry Date (end of the month)||Extended Use by Date (end of the month)|
|1||150||T4933||Jul 2018||Nov 2018|
|2||150||T5019||Aug 2018||Dec 2018|
|3||150||T5132||Aug 2018||Dec 2018|
|4||150||T5326||Sep 2018||Jan 2019|
|5||150||T5407||Sep 2018||Jan 2019|
|6||150||T5478||Sep 2018||Jan 2019|
|7||150||T5669||Oct 2018||Feb 2019|
|8||150||T5819||Oct 2018||Feb 2019|
|9||150||T5940||Oct 2018||Feb 2019|
|10||150||T6143||Nov 2018||Mar 2019|
|11||150||T6399||Nov 2018||Mar 2019|
|12||150||T6620||Nov 2018||Mar 2019|
|13||150||T6930||Dec 2018||Apr 2019|
|14||300||T4801||Jul 2018||Nov 2018|
|15||300||T4857||Jul 2018||Nov 2018|
|16||300||T5122||Aug 2018||Dec 2018|
|17||300||T5327||Sep 2018||Jan 2019|
|18||300||T5401||Sep 2018||Jan 2019|
|19||300||T5468||Sep 2018||Jan 2019|
|20||300||T5656||Oct 2018||Feb 2019|
|21||300||T5779||Oct 2018||Feb 2019|
|22||300||T5747||Oct 2018||Feb 2019|
|23||300||T5798||Oct 2018||Feb 2019|
|24||300||T5867||Oct 2018||Feb 2019|
|25||300||T6074||Nov 2018||Mar 2019|
|26||300||T6233||Nov 2018||Mar 2019|
|27||300||T6366||Nov 2018||Mar 2019|
|28||300||T6363||Nov 2018||Mar 2019|
|29||300||T6554||Nov 2018||Mar 2019|
|30||300||T6721||Nov 2018||Mar 2019|
|31||300||T6635||Dec 2018||Apr 2019|
|32||300||T6846||Dec 2018||Apr 2019|
Important: the extended use only applies to the lots of Jext® 150 mcg and Jext® 300 mcg auto-injectors listed 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.
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.
This announcement regarding the extended use of certain batches supersedes any notification that a patient may receive via the expiry alert service from www.jext.co.uk
- Lot numbers and labelled expiry dates are marked on the side of the box and on the autoinjector label itself.
- The specified lots of Jext® 150 mcg and 300 mcg autoinjectors will continue to work safely over the extended use period beyond the labelled expiry date.
- If you are unsure whether your Jext® auto injector is affected, talk to your pharmacist.
- The Jext® auto injectors should continue to be stored as labelled on the pack.
- Towards 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.
- You should continue to check periodically the viewing window in the label of your autoinjector to ensure that the liquid inside is clear and colourless. Do not use the autoinjector if the liquid is discoloured.
- You should consult your doctor or pharmacist if you have any concerns regarding this announcement. ALK cannot give specific treatment advice to patients.
If you require additional information or have any questions, please contact ALK Customer Services: 0118 903 7940.