U.S. product Auvi-Q provides alternative to help ease current EpiPen shortage in Canada
OTTAWA, Aug. 29, 2018 /CNW/ - 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
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.
"I'm pleased that we have been able to secure a supply of epinephrine auto-injectors for Canadians with life-threatening allergies and their loved ones, particularly as families across the country are currently preparing for the start of the school year. We will continue to work with partners and stakeholders on long-term solutions to make sure life-saving auto-injectors remain available."The Honourable Ginette Petitpas TaylorMinister of Health
"We commend Health Canada for leading the effort to secure an interim solution to the shortage of epinephrine auto-injectors, a necessary step to ensuring that Canadians have access to this life-saving medication. As one of the key stakeholders involved in this effort, we will continue to work with Health Canada and others towards a longer-term plan that focuses on having a minimum of two suppliers in Canada. Our immediate next step is to help ensure that patients receive clear information on when and how they can access this new supply."Jennifer Gerdts, Executive DirectorFood Allergy Canada
Previous related communications:
SOURCE Health Canada
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