FDA/CDC

FDA approves epinephrine autoinjector for infants, small children


 

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.

Auvi-Q 0.1-mg autoinjector kaleo
Auvi-Q 0.1-mg autoInjector

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.