(BPT) - AUVI-Q® (epinephrine injection, USP) is still available by prescription for children with life-threatening allergies.

Most kids spend the final weeks of summer amassing school supplies and cramming through summer reading lists. For children with life-threatening allergies and their parents, this time is also spent preparing for the challenge of navigating school cafeterias, packed classrooms and after-school programs.

An important part of that preparation often involves securing a prescription for an epinephrine auto-injector (EAI) before the first day of school. EAIs are used to treat life-threatening allergic reactions, including anaphylaxis. They do not take the place of emergency medical care, but are critical and potentially life-saving in an allergic emergency, so many parents and children prefer to keep a set at school.

However, some families are having trouble filling their EAI prescriptions this back-to-school season. In May, the U.S. Food and Drug Administration (FDA) reported that manufacturing delays caused an ongoing supply constraint for several EAI manufacturers, including authorized generic versions of the medication.

One EAI not experiencing any supply issues is AUVI-Q® (epinephrine injection, USP). It is developed by kaléo using a high-tech, 100% automated robotic production line and is FDA-approved in three doses: AUVI-q 0.1 mg for infants and toddlers weighing 16.5 lbs to 33 lbs, AUVI-Q 0.15 mg for children weighing 33 lbs to 66 lbs, and AUVI-Q 0.3 mg for anyone weighing 66 lbs or more.

AUVI-Q is the only EAI with an innovative electronic voice instruction system and visual cues that guide users step-by-step through the administration process. It’s been voted the number one prescribed branded EAI by allergists.1

AUVI-Q is not always available at local pharmacies, but kaléo is able to fill, and is filling, all order requests through their Direct Delivery service at www.auvi-q.com. So if a doctor prescribes you AUVI-Q, it can be shipped directly to your doorstep quickly. If you have commercial insurance and use the Direct Delivery service, you can get AUVI-Q for $0 out-of-pocket. Please see full terms and conditions: https://www.auvi-q.com/getting-auvi-q/. It’s important to note that patients must obtain AUVI-Q through the Direct Delivery service to ensure delivery to their home or healthcare provider’s office and the best expiration dating for AUVI-Q.

Not all pharmacies are experiencing a shortage of the more common EAIs, but knowing the alternatives before the school year begins is more important now than ever. A study published in 2017 determined that children are increasingly being treated for anaphylaxis, with an estimated 130 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.2

A recent survey of 289 parents with children who have food allergies found that >87% of parents find policies about epinephrine in the schools to be helpful. Similarly, in this same study, a majority of parents who reported that epinephrine policies were not in place felt that such policies were needed.3 Food allergies (the most common cause of anaphylaxis) affect 1 in every 13 children in the U.S.,4 or roughly two in every classroom.5

As parents and children with life-threatening allergies gear up for the challenges of another school year, finding an epinephrine auto-injector should not be one of them.

Indication

AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.

Important Safety Information

AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and the Patient Information at www.auvi-q.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

1 Based on IMS prescription data September 2017 – May 2018 (AUVI-Q 0.15 mg and 0.3 mg).

2 Motosue, M. et al. Increasing ED visits for anaphylaxis 2005-2014 The Journal of Allergy and Clinical Immunology: In Practice (2017) 5:1, 171-175.

3 Mustafa SS, Russell AF, Kagan O, et al. Parent perspectives on school food allergy policy. BMC Pediatrics. 2018. 18:164.

4 United States Census Bureau Quick Facts (2016 estimates).

5 FARE. Food Allergy Facts and Statistics for the U.S. https://www.foodallergy.org/life-with-food-allergies/food-allergy-101/facts-and-statistics [Accessed July 2018].