FDA OKs Epinephrine Auto-Injector for Use in Infants and Small Children

NOVEMBER 21, 2017
Officials with the FDA have expanded the approval of Kaleo’s epinephrine injection, USP (Auvi-Q) to include the treatment of life-threatening allergic reactions in infants and small children.1

With this approval, Auvi-Q 0.1 mg can be used to treat anaphylaxis in infants and small children weighing 16.5 to 33 pounds, who are at risk for or have a history of serious allergic reactions.

The new EAI also includes an electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.

According to a study published in the Allergy, Asthma, & Clinical Immunology, 43% of children weighing 16.5-33 pounds treated with a 0.15 mg EAI with a standard 12.7 mm needle length are at risk of the needle striking the bone.2 The 0.1-mg dose EAI has a shorter needle length, designed for use with infants and small children, and a lower dose of epinephrine than the current 0.15 mg and 0.3 EAIs. 

According to the company’s press release, there was a 129.8% increase in emergency room visits for anaphylaxis among children aged 4 years and younger between 2005 and 2014.

Auvi-Q 0.1 mg is projected to be available to patients in the first half of 2018.

  1. US FDA Approves Kaleo’s AUVI-Q® (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children [news release]. Kaleo’s website. . Accessed November 21, 2017.
  2. Kim H, et al. Ann Allergy Asthma Immunol. 2017 Jun;118(6):719-725.