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21 JANUARY 2019

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

 

 

Overview

In 2018 Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, experienced interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).

During this period, and to help manage product availability on an ongoing basis until a steady supply resumed, Mylan allocated product on a prescription-only basis for both EpiPen 0.3mg and 0.15mg, meaning patients could obtain up to a maximum of two EpiPen AAIs per prescription.

Over the last few months, product has continued to ship, and we are seeing improvement in patient’s ability to readily access both EpiPen 0.3mg and EpiPen 0.15mg in the UK. 

 

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  • Availability of EpiPen 0.3mg Adrenaline Auto-Injectors

    Availability of EpiPen 0.3mg Adrenaline Auto-Injectors

    There is currently good availability of EpiPen 0.3mg and the prescription validation process previously assigned is no longer in place.

    Pharmacies are now able to place orders and hold supply of EpiPen 0.3mg Adrenaline Auto-Injectors.

    Patients can present their prescription to a pharmacy to fulfil their prescription the same day, however you should check with your pharmacy to ensure that supply has been received and is available.

  • EpiPen 0.3mg Adrenaline Auto-Injectors - Extended Use Beyond Labelled Expiry Date for Select Lots

    EpiPen 0.3mg Adrenaline Auto-Injectors - Extended Use Beyond Labelled Expiry Date for Select Lots

    To address previous supply constraints of EpiPen 0.3mg, Mylan UK worked with the MHRA to obtain its approval to the use of nine specific lot (batch) numbers of EpiPen 0.3mg Auto-Injectors beyond the labelled expiry date by four months. Some of the affected lot numbers are listed in the table below.

    The extended use beyond expiry date is based on a careful review by Mylan and the MHRA of data about these specific batches provided by Pfizer.

    The relevant affected lots, which have labelled expiry dates between September 2018 and November 2018 are listed in the table below.

     

    Lot

    Labelled Expiry Date

    (end of the month)

    Extended Use by Date

    (end of the month)

    6FA794J

    07.2018

    11.2018

    6FA795Y

    07.2018

    11.2018

    7FA112F

    09.2018

    01.2019

    7FA106B

    09.2018

    01.2019

    7FA283B

    10.2018

    02.2019

    7FA251D

    10.2018

    02.2019

    7FA250B

    10.2018

    02.2019

    7FA265C

    11.2018

    03.2019

    7FA265B

    11.2018

    03.2019

     

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

    The extension of the use beyond the labelled expiry date does not apply to EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified above. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen not covered by the lot numbers above.

    Further information

    • To make sure patients can access their medicines during this supply constraint, the period that the nine specific lots of EpiPen 0.3mg (listed above) can be used has been extended by a further four months beyond the labelled expiry date on the pack.
    • 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, please talk to your pharmacist.
    • This extension of use beyond the labelled expiry date is based on data showing these nine batches of EpiPen 0.3mg auto-injectors will work just as well for this period. This has been reviewed by the UK medicines regulator, MHRA.  EpiPen auto-injectors should continue to be stored as labelled on the pack.
    • As with all EpiPens, patients should periodically visually inspect the adrenaline solution through the viewing window to make sure the solution is clear and colourless. If it is discoloured or contains solid particles the EpiPen should be replaced as soon as possible.
    • At the end of the extended use beyond the labelled expiry date period (the end of the month listed in the right column above), you will still need to obtain a new auto-injector by the usual means.
    • Please note that the information provided in this letter supersedes any other communication that you may receive from the Expiry Alert Service.
  • Availability of EpiPen Jr 0.15mg Adrenaline Auto-Injector

    Availability of EpiPen Jr 0.15mg Adrenaline Auto-Injector

    EpiPen Jr 0.15mg Adrenaline Auto-Injectors is currently available.

    To help manage product availability on an ongoing basis until a steady supply resumes, pharmacies are allocated product on a prescription-only basis and can place orders for up to a maximum of two EpiPen Jr 0.15mg Adrenaline Auto-Injectors per prescription.

    Patients should present their prescription to a pharmacy who will be able to place an order for up to a maximum of two EpiPen Jr 0.15mg Auto-Injectors per prescription.

    Pharmacies are able to place orders for up to a maximum of two EpiPen Jr 0.15mg Adrenaline Auto-Injectors per prescription and should follow the Instructions for Pharmacists when placing orders.

    A reminder that the extension of the use beyond the labelled expiry date for the nine lots of EpiPen 0.3mg listed above does not apply to any EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified. Please continue to adhere to the manufacturer’s expiry date labelled on any EpiPen 0.3mg not covered by the lot numbers above and all EpiPen Jr 0.15mg auto-injectors.

  • Information for Patients

    Information for Patients

    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 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 February, it remains valid (not expired) until February 28.

  • Instructions for Pharmacists

    Instructions for Pharmacists

    Pharmacies that are presented with a prescription for EpiPen Jr 0.15mg Auto-Injectors can place an order for up to a maximum of two EpiPen Jr 0.15mg Auto-Injectors per prescription. Please send anonymized prescriptions to Alliance Healthcare’s prescription validation service, either by Fax (0330 332 8126) or email (EOHotline@alliance-healthcare.co.uk). Please include your Alliance Healthcare account number when placing your 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-2019-0002 DOP: January 2019