FDA approves epinephrine autoinjector for infants and toddlers


The AUVI-Q 0.1 mg, an epinephrine autoinjector (EAI) for infants and toddlers weighing 16.5 to 33 pounds, will be available by prescription May 1, 2018, according to a press release from Kaléo, a privately-held pharmaceutical company.

“Anaphylactic reactions can be frightening and serious, and when experienced by the very young, some of whom can’t communicate about what’s happening, these episodes can be particularly alarming,” Vivian Hernandez-Trujillo, MD, a pediatric allergist and fellow of the American Academy of Allergy, Asthma and Immunology, said in a statement. “Now, caregivers can have the AUVI-Q 0.1 mg in hand to respond to an allergic emergency and safely administer epinephrine to infants and toddlers.”

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The device was granted Priority Review by the FDA because of its potential to significantly improve treatment of a serious condition and was approved Nov. 20, 2017. The injection is indicated to treat life-threatening allergic reactions, including anaphylaxis, in infants and toddlers. It features a shorter, retractable needle and a lower dose of epinephrine than other EAIs have, which makes it ideal for young children. This EAI also features a voice instruction system that provides caregivers step-by-step instructions on how to administer treatment. The epinephrine autoinjector also comes with two autoinjectors, plus an additional trainer for patients and caregivers to practice so they are prepared in an emergency situation.

The approval comes at a time when a higher percentage of children are being admitted to the hospital for food-related anaphylaxis: a 130% increase among children aged 0-4 years and a 196% increase in children aged 5-17 years.

The epinephrine autoinjector will be available for $0 out of pocket for commercially insured patients using the AUVI-Q AffordAbility Program and Direct Delivery Service starting May 1, 2018. More information concerning this EAI can be found here.

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