Dear Healthcare Professional
Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline Auto-Injectors
This letter is sent in agreement with the Medicines and Healthcare Products Regulatory Agency (MHRA) to inform you of the following:
To ease the current shortage of adrenaline autoinjectors, 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 four months. The affected lot numbers are listed in the table below and are also available on www.jext.co.uk.
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. 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® autoinjectors not specified. Patients must continue to adhere to the labelled expiry date on any Jext® autoinjector not covered by the lot numbers above.
Further information on the extended use of the listed lots of Jext® autoinjectors
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. 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.
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 autoinjector 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® 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. The Jext® autoinjectors 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 autoinjector will still need to be obtained.
Further information on recommendations to healthcare professionals
- Tell patients and caregivers about the extended use by date of the specified lots of Jext® 150 mcg and 300 mcg autoinjectors as listed above. This does not apply to other lots of Jext® autoinjectors not listed.
- Show patients and caregivers where to find the lot numbers on their device (on the side of the box and if necessary, on the device label itself) and encourage them to sign up for the Expiry Alert Service.
- Reassure patients and caregivers that their device will continue to work safely over the extended use period.
- Remind patients and caregivers that they should still obtain a new device near the end of the extended use period.
- Advise patients to continue to check periodically the viewing window in the label of their device to ensure the liquid inside is clear and colourless. Do not use the device if the liquid is discoloured.
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. If you require additional information or have any questions, please contact ALK Customer Services: 0118 903 7940.
If you are prescribed AAIs, to be well equipped during this time, we advise you to.
- Check the expiry date on your medication regularly
- If needed, get a repeat prescription from your GP well in advance
- Do not dispose of any ‘expired’ AAI devices before you have a new AAI prescription
- If necessary, revisit your GP to ask if they can prescribe an alternative medication
- If you are prescribed an alternative AAI device, ensure that you know how to use it and train others that may need to use it in an emergency
Do continue to always carry your AAIs with you and follow your usual risk management techniques to avoid your allergen and reduce the likelihood that you will experience a severe allergic reaction and need to use your adrenaline.
Frequently Asked Questions
What is anaphylaxis?
Anaphylaxis (pronounced ana-fill-ax-is) is a severe and life-threatening allergic reaction that can be fatal. Severe symptoms such as a swollen tongue, difficulty breathing or becoming unconscious usually develop suddenly, often within minutes after being exposed to an allergy trigger such as a particular food, insect stings or certain drugs. There’s no cure for anaphylaxis, so people at risk have two options: manage their condition and carry adrenaline, a potentially lifesaving emergency medication. You can find out more about anaphylaxis in our anaphylaxis factsheet: www.anaphylaxis.org.uk/our-factsheets.
What is an Adrenaline Auto-Injector?
Adrenaline is the first line treatment for severe allergic reactions (anaphylaxis) and is available on prescription in a pre-loaded injection device known as an Adrenaline Auto-Injector or AAI for self-use in an emergency. The AAIs prescribed in the UK at present are Emerade®, EpiPen® and Jext®. You can find out more about adrenaline in our adrenaline factsheet: www.anaphylaxis.org.uk/our-factsheets.
How do I check the expiry date on my AAIs?
As some of the additional stock available in the UK at present has an expiry date of October 2018, we are advising patients to check the expiry date on their Adrenaline Auto-Injectors when they receive them and not to dispose of any ‘expired’ AAI devices before they have obtained a new device.
Your AAI devices will have instructions for use printed on the outside and generally will have a shelf life of up to 18 months. The expiry date will be printed on the casing. Each of the three companies who distribute AAIs run an expiry alert service. If you register your device and expiry date with them, they will send you a reminder when it is due to expire.
Whichever devices you have been prescribed, it is important that you keep your AAIs in their original containers to prevent light exposure, do not store them above 25°C and do not freeze them. If the liquid in your AAI appears cloudy or discoloured, it should be replaced with a new device. If the liquid in the device is not cloudy or discoloured, the AAI device can still be used in an emergency.
What should I do if I have concerns about my prescription during a supply issue?
If you are worried about your prescription, we advise you to visit your GP and discuss this directly with them. If necessary, your GP can prescribe an alternative medication.
What should my pharmacist do if they are experiencing issues?
Your pharmacist should contact the supplier of your AAI through their distribution partner e.g. Alliance Healthcare, or their customer service department directly for updates regarding any issues they experience.
I have been prescribed a new brand of AAI, what should I do?
We believe your GP or pharmacist should make sure you know how to use your new brand of AAI. You should also train anyone who might be required to administer it in an emergency, such as family members and friends. You can order a trainer pen to practice with and find further help on the website relevant to the medication you carry.
An Emerade® trainer can be ordered from the Emerade® website: www.emerade-bausch.co.uk.
An EpiPen® trainer can be ordered from the EpiPen® websitehttp://www.epipen.co.uk.
A Jext® trainer can be ordered on the Jext websitehttp://www.jext.co.uk.
Can I get help with my prescription costs?
If you require support with prescription costs, prescription prepayment certificates (PPC) are available or you may be able to get help through the NHS Low Income Scheme (LIS). Find out more on the NHS Business Services Authority website here: https://www.nhsbsa.nhs.uk/nhs-help-health-costs.
I have a different question, can you help?
You can reach Bausch + Lomb UK customer services via +44 (0)208 781 2920.
You can reach Mylan UK customer services via +44 (0)1707 853 100.
You can reach ALK-Abelló customer services via 0118 903 7940.
You can contact our helpline and information team at [email protected] or call 01252 542 029 for support between Monday-Friday, 9am-5pm.