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 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.
Quote
"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
Quick Facts:
SOURCE Health Canada
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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.
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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.
Quote
"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
Quick Facts:
- Consumers should speak to their pharmacist or health care provider about how to access Auvi-Q once it is available in pharmacies. Health Canada encourages health care professionals and Canadians to continue to keep the supply situation in mind when dispensing or buying an auto-injector, to help keep supply available for those who need it most.
- Facilitating access to Auvi-Q is one of several actions Health Canada is taking—in collaboration with industry, provinces and territories, and stakeholders—to help reduce the impact of the EpiPen and EpiPen Jr shortage. Our continuing priority is an adequate, consistent and sustainable supply of authorized auto-injectors for Canadians over the long term.
- Canada has been experiencing shortages of EpiPen and EpiPen Jr auto-injectors for the past several months. Further to Health Canada's July 30, 2018 communication, Pfizer Canada has indicated that it has resumed shipments of EpiPen but that the supply of both EpiPen and EpiPen Jr continues to be limited while it works to return supply to normal levels.
- Health Canada continues to advise that, in light of the shortage, if an individual is experiencing an anaphylactic reaction and has only an expired auto-injector, they should use the expired product and immediately contact 911 or their local emergency service. Regardless of whether the product is expired, patients should get to the nearest hospital as soon as possible following the administration of the product.
- Auvi-Q Patient Information (including Instructions for Use)
- Health Canada communication to health care professionals (August 29, 2018): EpiPen Auto-Injector shortage and replacement with U.S. product Auvi-Q
- Interim Order
- Health Canada communication (2018-07-30): Health Canada updates Canadians on shortage situation involving EpiPen (0.3 mg) auto-injectors
- Pfizer Canada statement (2018-08-23): Update on EpiPen Auto-injector (0.3 mg) Supply
- Pfizer Canada statement (2018-07-30): EpiPen Auto-injector (0.3 mg and 0.15 mg) Supply
- Health Canada communication (2018-04-12): Shortage of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injectors in Canada
- Health Canada communication (2018-01-18): Shortage of EpiPen (0.3 mg) auto-injector in Canada
SOURCE Health Canada
