US-based kaléo announced the launch of ALLERJECT® in Canada on May 12, 2020, with product being available as of May 19th. Please read their statement.
Questions about the product
Q: What is ALLERJECT?
ALLERJECT is an epinephrine auto-injector used to treat anaphylaxis. It has a voice instruction system that helps guide a person through the injection process and a needle that retracts after the injection of epinephrine is complete.
Q: What dosages are available in Canada?
ALLERJECT comes in two doses:
- 0.15 mg dose for individuals who weigh 15 to 30 kg (33 lbs to 66 lbs)
- 0.3 mg dose for individuals who weigh 30 kg or more (66 lbs or more)
Q: What about a 0.1 mg dose, is it available in Canada?
The 0.1 mg dose is not available in Canada at this time.
Q: What is the price, is it more expensive than what is currently in the market?
kaléo indicates consumers should expect the price to be similar to the cost of other available devices in Canada.
Q: How does this new ALLERJECT differ from what was recalled in Canada in 2015?
Allerject was voluntarily recalled from the Canadian market in 2015 by the previous manufacturer Sanofi Canada, because of issues in a small number of devices that may have affected the delivery of the required amount of epinephrine.
In 2017, AUVI-Q was re-launched in the U.S. by kaléo. According to kaléo, the company conducted a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product. AUVI-Q is approved by the U.S. Food and Drug Administration, and all sites involved in its manufacturing are compliant with Good Manufacturing Practices (part of an internationally recognized quality assurance standard for drug manufacturing).
Q: Is ALLERJECT the same as AUVI-Q?
ALLERJECT is comparable to AUVI-Q, a product also made by kaléo, which is marketed in the U.S. only.
The 0.15 mg and 0.3 mg ALLERJECT auto-injectors contain the same drug and device components as AUVI-Q auto-injectors. The only difference between the two auto-injectors is the product labelling. Additionally, ALLERJECT is available in French while AUVI-Q is not.
Q. Is AUVI-Q still going to be available in Canada?
In response to a shortage of EpiPen® devices in Canada in 2018, the Minister of Health at that time, The Honourable Ginette Petitpas Taylor, signed an Interim Order in August 2018. This Interim Order authorized the temporary importation and sale of U.S. Food and Drug Administration (FDA) approved AUVI-Q. The Interim Order approval expired in August 2019 and AUVI-Q was phased out of the Canadian market. Going forward, only ALLERJECT will be available for distribution in Canada.
Questions on access
Q: Where can I obtain an ALLERJECT?
kaléo has advised that the device will be widely available in pharmacies across Canada starting on May 19, 2020. Please speak to your healthcare provider and check with your local pharmacy for additional availability details.
Q. Is a prescription required to obtain an ALLERJECT?
ALLERJECT is available as behind-the-counter medication and can be obtained without a prescription. However, different provinces and territories or insurance providers may require a prescription, depending on provincial or territorial requirements. You should contact your pharmacist or healthcare provider for information on how to obtain ALLERJECT.
Q: Will prescriptions for EpiPen® and ALLERJECT be interchangeable at the pharmacy?
This varies by province. In some cases, the pharmacist will need to call your healthcare professional to confirm that the switch is acceptable.
Q: How can I get a training device?
Training devices can be ordered from allerject.ca starting May 19, 2020.
Q: Should I be using a new device in this time of COVID-19?
The decision on which auto-injector to use should be discussed with your allergist and/or healthcare provider. During this time when there may be limited access to your primary healthcare provider, you can review the information provided on the ALLERJECT website (allerject.ca) to better understand the features of the device and how to administer it, if you are not already familiar with it.
Visit allerject.ca or call 1-888-680-7340 for more information.Tags: access to epinephrine, Allerject