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18 NOVEMBER 2019

Availability of EpiPen® 0.3mg and 0.15mg Adrenaline Auto-Injectors

 

Mylan’s manufacturing partner Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen®, has experienced manufacturing challenges which has resulted in interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).

To help manage product availability on an ongoing basis until a steady supply resumes, Mylan assigned a prescription validation process for EpiPen 0.3mg, meaning patients can obtain up to a maximum of two EpiPen 0.3mg AAIs per prescription.

The prescription validation process has now been extended to include EpiPen Jr 0.15mg.

Patients should follow the Instructions for Patients detailed below to fulfil their prescriptions and pharmacies should follow the Instructions for Pharmacists outlined below when placing orders.

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  • Extended use beyond labelled expiry date

    Extended use beyond labelled expiry date

    IMPORTANT UPDATE

    Extended Use-by Period for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
     

    Extended Use Beyond Labelled Expiry Date for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors

    In August 2019, Mylan was granted approval to a variation to permanently extend the shelf life of EpiPen 0.3mg auto-injectors from 20 months to 24 months.

    Mylan UK have obtained acceptance from the UK medicines regulator, MHRA, to extend the use of specific lot (batch) numbers of EpiPen® 0.3mg auto‐injectors already on the market, by 4 months beyond the labelled expiry date. The affected lot numbers are listed in the table below.

    EpiPen® 0.3mg (single pack)

    LOT

     

    Labelled Expiry Date         (end of the month)

     

    Extended Use-by Date      (end of the month)

     

    8FA092T

    09/2019

    01/2020

    8FA273E

    11/2019

    03/2020

    8KB332M

    02/2020

    06/2020

    8FA366K

    02/2020

    06/2020

    8FA367B

    02/2020

    06/2020

    8KB478B

    04/2020

    08/2020

    8KB474B

    04/2020

    08/2020

    8KB481B

    04/2020

    08/2020

    8KB510G

    05/2020

    09/2020

    8KB523G

    05/2020

    09/2020

    8KB648B

    06/2020

    10/2020

    8KB587B

    06/2020

    10/2020

    8KB630C

    06/2020

    10/2020

    8KB587F

    06/2020

    10/2020

    8KB671R

    07/2020

    11/2020

    9KB087B

    10/2020

    02/2021

    9KB148B

    10/2020

    02/2021

    9KB177AE

    11/2020

    03/2021

    9KB262B

    12/2020

    04/2021

    EpiPen® 0.3mg (twin pack)

    LOT

     

    Labelled Expiry Date         (end of the month)

     

    Extended Use-by Date      (end of the month)

     

    8KB558C

    05/2020

    09/2020

    8KB630D

    06/2020

    10/2020

    8KB671F

    07/2020

    11/2020

    9KB148J

    10/2020

    02/2021

    9KB177E

    11/2020

    03/2021

    9KB252P

    11/2020

    03/2021

    9KB301J

    12/2020

    04/2021

    Important: the extended use only applies to the lots of EpiPen 0.3 mg auto-injectors listed above.

    This extended use does not apply to EpiPen® 0.15mg Auto‐Injectors or any lot number of EpiPen 0.3 mg auto-injectors not specified. It is important that patients must continue to adhere to the labelled expiry date on any EpiPen® not covered by the lot numbers above.

    Further information

    There has been an interruption in the supply of adrenaline auto-injectors in the UK.  The overall market supply of adrenaline auto-injectors is being monitored by the Department of Health and Social Care.

    This 4-month extended use beyond the labelled expiry date for the specific lots listed above is based on supportive stability data for EpiPen® 0.3mg auto-injectors and has been reviewed by the MHRA.  The EpiPen® 0.3mg auto-injectors of these specific lots will continue to work safely and as intended within the extended use by date.  The EpiPen® auto-injectors should continue to be stored as labelled on the pack.

    You can find the lot number on the end-flap of the box and on the EpiPen® itself. If you are unsure whether your EpiPen® is affected, talk to your pharmacist.

    At the end of the extended use period (the end of the month listed under “Extended Use-by Date” in the table above), you will still need to obtain a new auto-injector by the usual means.

    Please note that the information provided in this communication supersedes any other communication that patients receive from the Expiry Alert Service.

    Contact Information

    If you require additional information or have any questions, please see contact information section below.

    EPI-2019-0269   DOP: September 2019

  • Instructions and Information for Patients

    Instructions and Information for Patients

     

    Patients requiring EpiPen 0.3mg or EpiPen Jr 0.15mg devices should present their prescription to a pharmacy where an order will be placed for up to a maximum of two EpiPen 0.3mg or two EpiPen Jr 0.15mg AAIs per prescription.

    Mylan is unable to make any specific treatment recommendation to individual patients. Patients should speak to their healthcare provider for appropriate actions to be taken. However, if you have a question about your EpiPen device please contact our Medical Information team who will be able to help you: +(0) 1707 853 000 (option 1) or email: info@remove-this.mylan.co.uk.

  • Information for Prescribers

    Information for Prescribers

    Please note, when validating the expiry date of an adrenaline auto-injector, the product expires on the last day of the month indicated. For example, if it expires in September, it remains valid (not expired) until 30 September.

  • Instructions for Pharmacists

    Instructions for Pharmacists

    Pharmacies that are presented with a prescription for EpiPen 0.3mg or EpiPen Jr 0.15mg Adrenaline Auto-Injectors can place an order for up to a maximum of two devices per prescription. Please send anonymized prescriptions to Alliance Healthcare’s prescription validation service, either by fax (0330 332 8126) or email (scriptvalidation@remove-this.alliance-healthcare.co.uk). Please include your Alliance Healthcare account number when placing your order.

    Orders from schools should be sent to Alliance Healthcare’s prescription validation service on the fax number or email address above.  Please note that the purchase of EpiPen 0.3mg and EpiPen Jr 0.15mg is currently limited to two devices per order.

  • Instructions for Schools

    Instructions for Schools

    To support children and young adults who may be at risk of anaphylaxis whilst away from home, the Human Medicines (Amendment) Regulations 2017 allows schools, without the need for a prescription, to purchase and hold supply of adrenaline auto-injectors. Regulations allow the purchase of a reasonable number of adrenaline auto-injectors for use on an occasional basis and as required.

    Schools requiring a supply of adrenaline auto-injectors to be used in emergency situations are now able to order EpiPen 0.3mg and EpiPen Jr 0.15mg through Mylan’s distributor, Alliance Healthcare.

    To place your order, please provide your local pharmacy with a letter, written on your school’s headed paper and signed by the principal or headteacher. The pharmacy will then send the request to Mylan’s distribution partner, Alliance Healthcare.

    Please be reminded that the purchase of EpiPen 0.3mg and EpiPen Jr 0.15mg is currently limited to two devices per order.

  • Contact Information

    Contact Information

    Telephone: +44 (0)1707 853 000

    Medical Information e-mail: info@remove-this.mylan.co.uk

 

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EPI-2019-0335 DOP: November 2019