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Caryn Foster Durham
Senior Director, Corporate Communications
(804) 256-7766
media.inquiries@kaleo.com
Caryn Foster Durham
Senior Director, Corporate Communications
(804) 256-7766
media.inquiries@kaleo.com
– Health Canada issues Interim Order authorizing importation and sale of U.S. FDA-approved AUVI-Q (0.15 mg and 0.3 mg) to patients in need
RICHMOND, VA. (August 29, 2018) – Kaléo, a privately-held pharmaceutical company, today announced that AUVI-Q® (epinephrine injection, USP) will be available in Canada starting September 7.
In response to the ongoing shortage of epinephrine auto-injectors in Canada, Minister of Health Ginette Petitpas Taylor signed an Interim Order, authorizing the importation and sale of U.S. Food and Drug Administration (FDA) approved AUVI-Q auto-injectors to patients at risk for, or have a history of, serious allergic reactions. Kaléo is working closely with Health Canada, provincial and territorial health authorities, as well as a distributor, to equitably distribute AUVI-Q to pharmacies across the country.
“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,” said Spencer Williamson, President and CEO of Kaléo. “When Health Canada contacted us regarding our ability to help address the ongoing shortage of epinephrine auto-injectors, our team immediately went to work on a response plan.”
Kaléo will be working with Health Canada on the regulatory and logistical requirements necessary for the return of Allerject® (epinephrine injection, USP), a similar product to AUVI-Q that was previously on the market in Canada.
“Having a second supplier in the market is vital for Canadians with life-threatening allergies, including allergies to food, not only in this interim period of limited supply, but in the longer-term as a permanent solution,” said Jennifer Gerdts, Executive Director of Food Allergy Canada. “With AUVI-Q in the market, Canadian families get access to a different option for an epinephrine auto-injector. This is a significant step towards alleviating the pressure Canadian families living with life-threatening allergies, including allergies to food, are facing, and is a measure Food Allergy Canada has been advocating for.”
AUVI-Q is approved by the U.S. Food and Drug Administration (FDA) to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. Its innovative features include voice instructions that help guide a user step-by-step through the epinephrine delivery process, as well as an auto-retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds. AUVI-Q does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q.
“We are taking the extraordinary measure to ship AUVI-Q auto-injectors approved for use in the U.S. market to Canada to do our part during this immediate crisis,” said Phil Rackliffe, General Manager of Allergy and Pediatrics, at Kaléo. “In addition, we look forward to working with Health Canada to bring back Allerject in 2019 as an option for patients in need.”
Identical twin brothers, Eric and Evan Edwards, the inventors of AUVI-Q and founders of Kaléo, grew up with life-threatening allergies. They know what it is like to live in fear of that life-or-death moment, both as patients and parents of food-allergic children. Eric and Evan Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.
While the emergency availability of AUVI-Q is expected to help supplement existing supplies, Health Canada anticipates that the overall supply of epinephrine auto-injectors in Canada will remain below normal and should be carefully managed. Health Canada is encouraging healthcare professionals to continue to keep the ongoing supply situation in mind when dispensing epinephrine auto-injectors.
Canadian patients can learn more about AUVI-Q at https://www.canada.ca/en/health-canada/news/2018/08/health-minister-announces-access-to-a-us-approved-epinephrine-auto-injector.html
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About Anaphylaxis
Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.
About AUVI-Q (0.3 mg and 0.15 mg)
AUVI-Q (epinephrine injection, USP) Auto-injector is used to treat life- threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.
AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about AUVI-Q (0.3 mg and 0.15 mg) visit: https://www.canada.ca/en/health-canada/news/2018/08/health-minister-announces-access-to-a-us-approved-epinephrine-auto-injector.html
Indication
AUVI-Q® (epinephrine injection, USP) is used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.
Important Safety Information
AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.
Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Please see the full Prescribing Information and the Patient Information at www.auvi-q.com.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
For other health product inquiries related to this communication, contact Health Canada at:
Regulatory Operations and Regions Branch
E-mail: dcviu_uvcem@hc-sc.gc.ca
Telephone: 1-800-267-9675
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
U.S. patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Kaléo (kuh-LAY-oh)
Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life- threatening medical conditions. Our mission is to provide innovative solutions that empower patients to confidently take control of their medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives and are an integral part of our product development process. Kaléo is a privately-held company headquartered in Richmond, Virginia in the United States. For more information, visit www.kaleo.com.