The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications ( Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1 ).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
