Jext® Extended Use Beyond Labelled Expiry Date for Selected Lots
You may be aware of the recent supply issues affecting some brands of adrenaline auto-injectors, which have resulted in increased demands on alternative brands of auto-injectors including Jext. The overall market supply of adrenaline auto-injectors is being monitored 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 support and maintain an overall adequate supply, ALK has obtained acceptance from the UK medicines regulator, 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.
Important: the extended use only applies to the lots of Jext® 150 mcg and Jext® 300 mcg auto-injectors 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.
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.
Information for Patients
- Lot numbers and labelled expiry dates are marked on the end-flap of the box and on the auto-injector label itself.
- The specified lots of Jext® 150 mcg and 300 mcg auto-injectors 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 auto-injector to ensure that the liquid inside is clear and colourless. Do not use the auto-injector 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.