kaléo announced that the Food and Drug Administration (FDA) has approved the use of Auvi-Q (epinephrine injection) 0.1mg Auto-Injector for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5–33lbs (7.5–15kg) who are at risk for or have a history of serious allergic reactions.
Auvi-Q is a compact auto-injector with an electronic voice instruction system that guides the user through the delivery process; the needle also automatically retracts after administration. The new 0.1mg dose features a shorter needle and a lower epinephrine dose than the currently approved 0.15mg and 0.3mg epinephrine auto-injectors.
Epinephrine is a non-selective alpha and beta-adrenergic receptor agonist. Its effect on the alpha-adrenergic receptors lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Its effect on beta-adrenergic receptors causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis.
“The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as four to six months old, be introduced to peanut-containing foods,” said Eleanor Garrow-Holdingiii, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT).
Auvi-Q is already available as 0.15mg and 0.3mg strength auto-injectors. The new 0.1mg dose is anticipated to launch in the first half of 2018.
For more information call (844) 828-8472 or visit Auvi-Q.com.