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24 JUNE 2020

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

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

Supply has stabilised further and there is good availability of both EpiPen Jr 0.15mg and EpiPen 0.3mg AAIs. The prescription validation process previously applied is no longer in place and stock can be ordered as normal.

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  • Information for Prescribers

    Information for Prescribers

    The prescription validation previously in place no longer applies and stock can be ordered as normal.

    Prescribers are reminded that Medicines and Health Regulatory Agency (MHRA) guidelines recommend patients carry two adrenaline auto-injectors at all times.

  • Instructions for Pharmacists

    Instructions for Pharmacists

    Pharmacies are able to place orders and hold stock of EpiPen Jr 0.15mg and EpiPen 0.3mg AAI devices so that patient prescriptions can be fulfilled the same day.

    Please place your order through Alliance Healthcare, stating your account number in the request.

  • Instructions for Hospitals

    Instructions for Hospitals

    Hospitals are able to place orders and hold stock of EpiPen Jr 0.15mg and EpiPen 0.3mg AAIs.

    Please place your order through Alliance Healthcare, stating your account number in the request.

  • 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.

    Orders for EpiPen Jr 0.15mg and EpiPen 0.3mg can be made through your local pharmacy. Please provide your 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.

  • Supply of US-labelled EpiPen® 0.3mg Adrenaline Auto-Injectors

    Supply of US-labelled EpiPen® 0.3mg Adrenaline Auto-Injectors

    EpiPen (Adrenaline) Auto-Injector 0.3 Mg: supply of a batch (no. 9FM766) with US-labelled auto-injectors packaged in UK cartons with a UK leaflet

    • Mylan has released a batch of US-labelled EpiPen auto-injectors (Batch no. 9FM766) to enable continuous access of auto-injectors in the UK following approval from the MHRA.

    • The EpiPen auto-injectors in this batch are affixed with a US label, and are packaged (as single packs) into UK cartons along with UK patient information leaflets.

    • The drug name is epinephrine in the US but is known as adrenaline in the UK. Patients and carers familiar with the term adrenaline may be confused.

    Further information on the safety concern and recommendations

    The auto-injector device in this batch is exactly the same as the normal UK EpiPen in every way except for the information on the label on the device.

    Other differences between the US-labelled and UK-labelled auto-injectors are:

    • The UK label has the instruction to ‘Dial 999, ask for ambulance and state 'anaphylaxis!', which is replaced with ‘Get emergency medical help!’ on the US label.

    • The warning ‘Keep of the reach and sight of children’ is omitted on the US auto-injector label. However, the UK carton and patient information leaflet include this statement.

    Please see below a comparison of the US and UK labels on the autoinjectors:

     

    UK EpiPen 0.3 mg label                                                      US EpiPen 0.3mg label

     

     

    Reminder: Patients and carers should ‘Dial 999, ask for an ambulance and state anaphylaxis!’ after every use of the EpiPen auto-injector.

    The label on the EpiPen (epinephrine) auto-injector is meant for the US. Therefore, patients and carers should read the outer carton and enclosed patient information leaflet which is designed for UK patients.

    Click here to download additional patient information leaflet

    Contact Information

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

  • Extended Expiration Dates for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors

    Extended Expiration Dates for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors

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

    For AAIs already on the market, prior to the permanent extension of shelf life above, Mylan UK obtained approval from the MHRA to extend the use of specific lot (batch) numbers of EpiPen® 0.3mg auto‐injectors, 4 months beyond the labelled expiry date. The affected lot numbers are listed in the table below.

    This batch-specific extended use does not apply to EpiPen® 0.15mg AAI 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 below.

     

    EpiPen® 0.3mg (single pack)

    LOT

       

    Original Expiry Date

     Extended Expiry Date

       

    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

    Further information

    You can find the lot number on the end-flap of the box and on the EpiPen® itself. If you’re 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 Expiry 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

    Contact Information

    Telephone: +44 (0)1707 853 000

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

 

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EPI-2020-0320 DOP: June 2020