U.S. product Auvi-Q provides alternative to help ease current EpiPen shortage in Canada



August 29, 2018 - Ottawa, ON - Health Canada



Epinephrine auto-injectors are essential to Canadians with life-threatening allergies and their loved ones, particularly parents preparing for the back-to-school season.



The Honourable Ginette Petitpas Taylor, Minister of Health, today announced that she has signed an Interim Order that will facilitate the import into Canada of the U.S.-approved Auvi-Q epinephrine auto-injectors for a period of two weeks while approval is sought to extend the order for up to one year.



This measure is in response to ongoing shortages of EpiPen (0.3 mg) and EpiPen Jr. (0.15 mg). Auvi-Q, made by Kaléo, has been approved by the U.S. Food and Drug Administration. 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.



Auvi-Q 0.3 mg is expected to be available for pharmacies to order by the end of the week and in pharmacies as of September 7. Auvi-Q 0.15 mg may be made available by Kaléo under the Interim Order in future, depending on need and product availability.‎



Auvi-Q is comparable to Allerject, another Kaléo product that is authorized, but not currently marketed, in Canada. The primary difference between Auvi-Q and Allerject is that the U.S. product does not include French labelling and instructions. An English and French instruction sheet for consumers will be provided with the Auvi-Q product at the time of sale to help ensure that patients and caregivers administer the drug safely and effectively.



A copy of the instruction sheet is available on Health Canada’s website. Health Canada is also communicating with health care professionals to provide additional detailed product dispensing information.

