Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline A

24-Sep-2019

Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline Auto-Injectors

This update has been agreed with the UK medicines regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), to inform you of the following:

There are supply issues affecting some brands of adrenaline auto-injectors on the UK market. 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 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

A5263

Sep 2019

Jan 2020

2

150

A5682

Sep 2019

Jan 2020

3

150

A5713

Sep 2019

Jan 2020

4

150

A5848

Sep 2019

Jan 2020

5

150

A5850

Oct 2019

Feb 2020

6

150

A6014

Oct 2019

Feb 2020

7

150

A6244

Nov 2019

Mar 2020

8

150

A6705

Nov 2019

Mar 2020

9

150

A6934

Dec 2019

Apr 2020

10

150

A7052

Nov 2019

Mar 2020

11

150

A7082

Nov 2019

Mar 2020

12

150

A7237

Dec 2019

Apr 2020

13

150

A7317

Dec 2019

Apr 2020

14

150

A7403

Dec 2019

Apr 2020

15

150

A7505

Dec 2019

Apr 2020

16

150

B3313

Dec 2019

Apr 2020

17

300

A5198

Aug 2019

Dec 2019

18

300

A5283

Aug 2019

Dec 2019

19

300

A5364

Aug 2019

Dec 2019

20

300

A5501

Sep 2019

Jan 2020

21

300

A5676

Sep 2019

Jan 2020

22

300

A5793

Sep 2019

Jan 2020

23

300

A5994

Sep 2019

Jan 2020

24

300

A5910

Oct 2019

Feb 2020

25

300

A5988

Oct 2019

Feb 2020

26

300

A6074

Oct 2019

Feb 2020

27

300

A6148

Nov 2019

Mar 2020

28

300

A6330

Nov 2019

Mar 2020

29

300

A6569

Nov 2019

Mar 2020

30

300

A6848

Nov 2019

Mar 2020

31

300

A6862

Dec 2019

Apr 2020

32

300

A7095

Dec 2019

Apr 2020

33

300

A7215

Dec 2019

Apr 2020

34

300

A7232

Dec 2019

Apr 2020

35

300

A7329

Dec 2019

Apr 2020

36

300

A7393

Dec 2019

Apr 2020

37

300

A7395

Dec 2019

Apr 2020

38

300

A7511

Dec 2019

Apr 2020

39

300

B3042

Dec 2019

Apr 2020

40

300

B3141

Dec 2019

Apr 2020

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.

Further information on the extended use of the listed lots of Jext® autoinjectors

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.

To further ease the shortfall, the period that 40 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 end-flap 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.

 

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 auto-injectors as listed above.  This does not apply to other lots of Jext® auto-injectors not listed.

  • Show patients and caregivers where to find the lot numbers on their device (on the end-flap 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.

Call for reporting

Please continue to report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme.

Please report:

  • all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason
  • all suspected ADRs associated with new drugs and vaccines identified by the black triangle▼

It is easiest and quickest to report ADRs online via the Yellow Cards website - https://yellowcard.mhra.gov.uk/ or via the Yellow Card app available from the Apple App Store or Google Play Store.

Alternatively, prepaid Yellow Cards for reporting are available:

  • by writing to FREEPOST YELLOW CARD (no other address details necessary)
  • by emailing yellowcard@mhra.gov.uk
  • at the back of the British National Formulary (BNF)
  • by telephoning the Commission on Human Medicines (CHM) free phone line: 0800-731-6789 or
  • by downloading and printing a form from the Yellow Card website (see link above)

When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, and product brand name.


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