FDA Approves Auvi-Q with Lower Dose for Infants and Small Children

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Today, kaléo announced the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application for AUVI-Q® 0.1 mg, the first epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds at risk for or have a history of serious allergic reactions.
Children are increasingly being treated for anaphylaxis with a 129.8% increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014. According to a study published in Allergy, Asthma & Clinical Immunology, 43% of children weighing 16.5 pounds (7.5 kilograms) to 33 pounds (15 kilograms) treated with a 0.15 mg EAI having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency. The needle length in AUVI-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.

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“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Dr Vivian Hernandez-Trujillo, a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies and anaphylaxis. “Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”
The AUVI-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.

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Dave Bloom
Dave Bloom
Dave Bloom is CEO and "Blogger in Chief" of SnackSafely.com.

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