Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext®
Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline Auto-Injectors.
This notification has been released in agreement with the UK medicines regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), to inform you of the following:
There is currently a shortage of Jext® adrenaline auto-injectors in the UK. Due to the recent recall of a competitor product, we have seen an increased demand for JEXT® in all countries, with demand now far exceeding our normal expectations and forecasting. To support and maintain an overall adequate supply, ALK has obtained acceptance from the 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 two months. The affected lot numbers are listed in Table 1 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 | 300 | K3984 | Dec 2023 | Feb 2024 |
| 2 | 300 | K4161 | Dec 2023 | Feb 2024 |
| 3 | 300 | K4338 | Dec 2023 | Feb 2024 |
| 4 | 300 | K4160 | Dec 2023 | Feb 2024 |
| 5 | 300 | K4408 | Dec 2023 | Feb 2024 |
| 6 | 300 | K4414 | Dec 2023 | Feb 2024 |
| 7 | 300 | K5311 | Jan 2024 | Mar 2024 |
| 8 | 300 | K4672 | Feb 2024 | Apr 2024 |
| 9 | 300 | K4920 | Feb 2024 | Apr 2024 |
| 10 | 300 | K5183 | Feb 2024 | Apr 2024 |
| 11 | 300 | K5243 | Feb 2024 | Apr 2024 |
| 12 | 300 | K5483 | Feb 2024 | Apr 2024 |
| 13 | 300 | K5619 | Feb 2024 | Apr 2024 |
| 14 | 300 | K5623 | Feb 2024 | Apr 2024 |
| 15 | 300 | K5846 | Feb 2024 | Apr 2024 |
| 16 | 300 | K5806 | Feb 2024 | Apr 2024 |
| 17 | 300 | K6197 | Feb 2024 | Apr 2024 |
| 18 | 150 | K4072 | Dec 2023 | Feb 2024 |
| 19 | 150 | K4558 | Dec 2023 | Feb 2024 |
| 20 | 150 | K4627 | Dec 2023 | Feb 2024 |
| 21 | 150 | K5384 | Jan 2024 | Mar 2024 |
| 22 | 150 | K4938 | Feb 2024 | Apr 2024 |
| 23 | 150 | K5453 | Feb 2024 | Apr 2024 |
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® autoinjectors not specified. Patients must continue to adhere to the labelled expiry date on any Jext® autoinjector not covered by the lot numbers above.
This extended use of two months beyond the labelled expiry date for the specific lots is based on supportive stability data for Jext® autoinjectors and has been reviewed by the MHRA. The Jext® autoinjectors 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 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® autoinjector is affected, talk to your pharmacist.
- The Jext® autoinjectors 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 autoinjector 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 or infouk@alk.net.
Code: GB-JXT-2300009 Date of Preparation: November 2023