First infant epinephrine injector on market

After FDA approved the first epinephrine injection specifically for infants and toddlers last year, the drug is now on the market.

The epinephrine injection (AUVI-q, Kaleo) 0.1 mg for infants and toddlers has a shorter needle length and lower dose of epinephrine than other FDA-approved epinephrine auto-injectors (EAIs), kaléo said in a statement.

The product is needed, according to the pharma manufacturer, because there was an estimated 130% increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.

“Before the introduction of AUVI-q 0.1 mg, the youngest and most vulnerable population did not have a treatment for anaphylaxis designed for them,” said Eric S. Edwards, MD, PhD, vice president of innovation and research & development at kaléo. “This day means a lot to me personally, as I suffer from life-threatening allergies and have a child who was diagnosed with life-threatening allergies as an infant.”

“I would have loved to have had the AUVI-q 0.1 mg available back when my son was an infant and was first diagnosed with an egg and wheat allergy,” said Todd Mahr, MD, a pediatric allergist and president-elect of the American College of Allergy, Asthma and Immunology, in the statement. “Prior to this, there was no EAI specifically designed for infants and toddlers weighing 16.5 to 33 pounds, so the AUVI-q 0.1 mg helps to address that significant unmet need.”

Each AUVI-q 0.1 mg prescription includes 2 auto-injectors and 1 Trainer for patients and caregivers to practice administration before an allergic emergency. AUVI-q 0.1 mg features a voice instruction system that helps guide caregivers step-by-step through the injection process, as well as a needle that automatically retracts following administration.