EpiPen (epinephrine USP) Auto-Injector - Interim Order allowing the importation of AUVI-Q in response to shortages of EpiPen and EpiPen Jr

Starting date:
August 29, 2018
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-67658

Audience

Pharmacists, primary care physicians and nurses

Key messages

  • The Minister of Health has signed an Interim Order that will facilitate the import of AUVI-Q epinephrine auto-injectors into Canada as an emergency measure in response to the ongoing shortages of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg).
  • AUVI-Q is marketed by Kaléo in the U.S. and has been approved by the U.S. Food and Drug Administration. It is comparable to Allerject, another Kaléo epinephrine auto-injector product that is authorized, but not currently marketed, in Canada.
  • Due to urgent need, AUVI-Q 0.3 mg will be available for order from McKesson Canada by the end of the week of August 27 (For contact information see Information for healthcare professionals below). AUVI-Q 0.15 mg may be made available as required, depending on need and product availability. 
  • Both EpiPen and AUVI-Q deliver the same labelled dose of epinephrine.  However, unlike EpiPen, AUVI-Q has a retractable needle as well as an electronic voice instruction system. (Currently, this is available in English only.)
  • Pharmacists are reminded to:
    • Review the AUVI-Q product information with patients or caregivers. (English and French prescribing information, patient information, instructions for use, and trainer instructions are available for download at the following address: www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements.html)
    • Distribute Patient Instructions for Use with each dispensed AUVI-Q auto-injector.
    • Use their discretion to conserve supply, as AUVI-Q is packaged such that each box contains 2 auto-injectors plus a trainer device (i.e., opening packages and dispensing single auto-injectors as necessary).
  • Health Canada continues to work closely with suppliers, the provinces and territories, and stakeholders to help minimize the impact of this shortage on Canadians, with the goal of achieving an adequate, consistent and sustainable supply of authorized epinephrine auto-injectors in Canada as soon as possible.

   

Issue

As an emergency measure in response to the ongoing shortages of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg), the Minister of Health has signed an Interim Order that will facilitate the import of AUVI-Q epinephrine auto-injectors in 0.3 mg and 0.15 mg dosage formats to Canada.

The Interim Order is an extraordinary measure to address an urgent need, which at this time is for the 0.3 mg dose. AUVI-Q 0.3 mg is expected to be available for pharmacies to order by the end of the week of August 27, and in pharmacies as of September 7.

According to Pfizer Canada, supplies of EpiPen Jr (0.15 mg) remain available in Canada. AUVI-Q 0.15 mg may be made available as required, depending on need and product availability.

Products affected

AUVI-Q (0.15 mg and 0.3 mg epinephrine auto-injectors, USP) manufactured by Kaléo. 

Health Canada issued temporary product identification numbers:

  • AUVI-Q 0.15 mg – 02480360
  • AUVI-Q 0.3 mg – 02480379

Background information

EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) are the only epinephrine auto-injector products marketed for sale in Canada at this time. They have been in short supply for several months in Canada. Given the uncertainty around supply and the life-saving nature of the drug in the treatment of anaphylaxis, the Minister of Health has signed an Interim Order that will allow the importation of AUVI-Q 0.15 mg and 0.3 mg epinephrine auto-injectors from the United States (U.S.) to supplement supplies of authorized product as long as such a need exists.

AUVI-Q is a medication used to treat life-threatening allergic reactions including anaphylaxis in people who are at risk for, or have a history of, serious allergic reactions. AUVI-Q is not authorized for sale in Canada; however, Health Canada is enabling its import as an emergency temporary measure to help ease the supply situation. AUVI-Q is approved by the U.S. Food and Drug Administration.

Both Epipen and AUVI-Q deliver the same labelled dose of epinephrine, however, AUVI-Q unlike EpiPen, has a retractable needle as well as an electronic voice instruction system.

Who is affected

Information for consumers

To help manage the impact of the ongoing shortage of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg), Health Canada is enabling the temporary importation of an epinephrine auto-injector product, called AUVI-Q, from the U.S.

AUVI-Q contains a medicine used to treat life-threatening allergic reactions, including a severe allergic reaction (anaphylaxis), in people who are at risk for or have a history of serious allergic reactions.

AUVI-Q 0.3 mg is expected to be available for pharmacies to order by the end of the week of August 27, and in pharmacies as of September 7. According to Pfizer Canada, supplies of EpiPen Jr (0.15 mg) remain available in Canada. AUVI-Q 0.15 mg may also be made available as required, depending on need and product availability.

How to use AUVI-Q:

  • Each AUVI-Q contains 1 dose of medicine.
  • AUVI-Q should only be injected into the muscle of your outer thigh. It can be injected through your clothing, if needed.
  • Read the Instructions for Use provided with AUVI-Q for information about the correct way to use the product.
  • AUVI-Q contains an electronic voice instruction system to help guide you through each step of your injection. (Currently, this is only available in English).
  • A trainer device for AUVI-Q with a separate Trainer Instructions for Use leaflet is included with AUVI-Q. Additional training resources are available at www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements.html.

Canadians should speak to their pharmacist or health care provider about how to access AUVI-Q, as requirements vary among jurisdictions.

Information for healthcare professionals

The US-labelled AUVI-Q products are the same as the Canadian EpiPen products (0.3 mg) and EpiPen Jr (0.15 mg) with respect to medicinal ingredient. However, the following differences between the currently approved Canadian EpiPen and U.S. AUVI-Q should be noted:

  • AUVI-Q is packaged in a box that contains 2 auto-injectors plus a trainer. In order to help manage the ongoing shortage, pharmacists are asked to use their discretion to conserve supply (i.e., opening packages and dispensing single auto-injectors with patient Instructions for Use leaflet as necessary).
  • AUVI-Q contains an electronic voice instruction system to help guide the patient through each step of injection. (Currently, this is available in English only.)
  • AUVI-Q contains a retractable needle (after a 2-second dose delivery time).
  • Healthcare professionals should review the patient instructions and operation of AUVI-Q, in detail, with the patient or caregiver.

Complete French and English product information (prescribing information including Dosage and Administration, patient information, instructions for use and trainer instructions) will be available online at: www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements.html.

AUVI-Q is available for order from McKesson Canada at:

Eastern Canada: 1-866-604-4595
Ontario: 1-888-737-7780
Western Canada :1-866-203-5233
Quebec: 1-800-363-5969

Action taken by Health Canada

In light of a shortage, Health Canada has enabled the importation of AUVI-Q, an epinephrine auto-injector product marketed in the U.S., as an interim measure to help mitigate the impact of the shortage on Canadians. Health Canada will continue to closely monitor the situation and will update Canadians, as required.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving AUVI-Q should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Regions Branch
E-mail: dcviu_uvcem@hc-sc.gc.ca
Telephone: 1-800-267-9675