Update: U.S. FDA Approves Kaléo's AUVI-Q® (Epinephrine Injection, USP) 0.1 mg Auto- Injector for Life-Threatening Allergic Reactions in Infants and Small Children

Image courtesy of AUVI-Q 

Last week, I was invited to a tea and learn session sponsored by kaleo (manufacturer of  
AUVI-Qabout their just approved - "Kaléo’s AUVI-Q® (Epinephrine Injection, USP) 0.1 mg Auto- Injector for Life-Threatening Allergic Reactions in Infants and Small Children."

(NB: I was not paid to attend this event but I do consult with kaleo in other capacities.)

This is a big deal because there is *nothing* currently on the market for children 16.5 - 33 pounds. 

More from kaleo about this new product from AUVI-Q:

Image courtesy of AUVI-Q 
FDA-approved AUVI-Q 0.1 mg is the first and only EAI specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and toddlers weighing 16.5 to 33 lbs (7.5 to 15 kg) who are at risk for or have a history of serious
allergic reactions.

The AUVI-Q 0.1 mg auto-injector offers a lower dose of epinephrine and a shorter exposed needle length (approximately 7.4 mm) than current FDA-approved 0.15 mg and 0.3 mg epinephrine auto-injectors. 

More from kaleo about the family of products from AUVI-Q:

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. I

n 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, 0.15 mg and 0.1 mg) visit www.auvi-q.com.


It was very interesting to hear the panel discuss food allergies, new guidance from the National Institutes of Health (NIH) about how and when to introduce food allergens safely (particularly peanut products), what to watch out for and how to communicate with a child’s physician to ensure the appropriate introduction of potential allergens

For me, it was especially interesting to hear James R. Baker, Jr., MD, CEO and CMO of FARE (Food Allergy & Research Education) talk about how when he was an allergist in the 1980s, food allergies were so rare they’d bring in the medical interns to meet someone who had them. 

Hello, food allergy adults - this was us, trailblazers!


UPSHOT: If you are a parent of an infant with food allergies, talk to your healthcare provider about epinephrine auto injector options for your child.


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