Canada Permits Crisis Import of Auvi-Q Device to Ease Epinephrine Shortage

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By:
in Food Allergy, News
Published: August 29, 2018

Updated Aug. 30, 2018: With Canadian supplies of EpiPen auto-injectors remaining scarce, Canada’s Health Minister Ginette Petitpas Taylor on Aug. 29 signed an interim order that allows U.S.-approved Auvi-Q epinephrine auto-injectors to be imported for a two-week period. She is further seeking approval to extend the order for up to one year.

“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,” the minister said in a statement. “We will continue to work with partners and stakeholders on long-term solutions to make sure life-saving auto-injectors remain available.”

Until this announcement, Canadians with food and stinging insect allergies were finding it difficult to fill prescriptions for the EpiPen 0.3 mg auto-injector, distributed by Pfizer Inc. Many consumers were left on back order for months for the device, which has been the only epinephrine device currently marketed in Canada. By late July, Health Canada announced that stock was expected to run out, and at a majority of Canadian pharmacies, this was the case.

Pfizer Canada said an EpiPen shipment went out in late August, but acknowledged to Allergic Living that it was only one month’s supply. The facility that manufactures EpiPens in Missouri has faced continuing production delays that have led to months of shortages in the U.S., Canada, the U.K. and Australia.

“When Health Canada contacted us regarding our ability to help the ongoing shortage of epinephrine our team immediately went to work on a response plan,” said Spencer Williamson, president and CEO of Kaléo. “As a company founded by patients with life-threatening allergies, we understand how critically important it is to be able to access an epinephrine auto-injector when it is needed,” he said.

The compact Auvi-Q device, which is known for its voice-guided instructions, is available in the same 0.3 mg dose as the EpiPen and also comes in a younger child version. Health Canada said the Auvi-Q 0.15 mg (for children under 66 pounds) may be made available by Kaléo under future interim order, depending on need and availability.‎

For the U.S. market, the Auvi-Q is sold as a two-pack device set. In Canada, auto-injectors have been sold as single devices. Under the current order, Health Canada is giving pharmacists the discretion to open packs and sell one device per customer, if they see this as necessary to manage the limited epinephrine supply.

Auvi-Q used to be distributed in Canada as the brand, Allerject, and that remains authorized, though not currently marketed. In a statement, Kaléo also said it is working with Health Canada on regulatory and logistical issues in order to relaunch the Allerject-branded device in Canada in 2019.

As a U.S. product, the Auvi-Q will not be available with French labeling and instructions, which are normally required in Canada. However, Health Canada’s statement says, “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.”