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The Upcoming School Year is Expected to be Fraught with Uncertainty, Particularly for Children with Life-Threatening Food Allergies

Back-to-school is the most common time for parents to take their children to pediatricians for their annual wellness visits; but many parents are reconsidering wellness visits due to COVID-19

Richmond, Va. (August 12, 2020) – Kaléo, a privately-held pharmaceutical company, is teaming up with the food allergy advocacy community to elevate attention to the unique needs of children with food allergies returning to what could be a very different school environment due to COVID-19. Parents of children with food allergies, from daycare to high school students, need to ensure they are prepared for an allergic emergency. Two essential ways to prepare are to have an Anaphylaxis Emergency Plan and an epinephrine auto-injector on hand, in time for the upcoming school year, especially when faced with non-traditional classrooms and environments.

Each year, an estimated 56 million children go back to school to attend elementary, middle and high schools across the United States.¹ Approximately 8% of children in the United States have a serious food allergy² or 1 in 13 children, which is about two students per classroom.³ Back-to-school check-ups are often one of the few opportunities each year that children have with their pediatricians to get immunizations and refill epinephrine auto-injector prescriptions.⁴ However, due to COVID-19, pediatricians across the U.S. have seen a drop in the number of children coming in for appointments.⁵

“As an educator, I know first-hand how essential it is for children with food allergies to be prepared and control the environment, to the extent possible, and a newly-imagined classroom or school situation during COVID-19 shakes that up,” said Allie Bahn, Global Outreach and Education Coordinator, Global Allergy & Airways Patient Platform. “One way I encourage parents of children with food allergies to prepare is to have an Anaphylaxis Emergency Plan and to speak with school staff about what to do in the case of an emergency, including how to quickly access their epinephrine auto-injector.”

Due to COVID-19, several agencies have implemented new guidelines for students to safely re-enter schools. The CDC is recommending students bring their own meals as feasible and eat lunch in the classroom with desks socially distanced, while ensuring the safety of children with food allergies.⁶

“Parents should speak to their doctor about their children’s annual epinephrine auto-injector refill,” says Dr. Vivian Hernandez-Trujillo, Pediatric Allergist & Immunologist, Allergy & Immunology Care Center of South Florida and spokesperson for Kaléo. “One treatment I prescribe to patients, AUVI-Q® (epinephrine injection, USP) auto-injector, can be mailed directly to their homes, which is a great option for social distancing.”

AUVI-Q is about the size of a credit card and thickness of a cell phone and fits in most pockets. AUVI-Q is available in three doses – AUVI-Q 0.3 mg for those weighing 66 pounds (30 kilograms) or more, AUVI-Q 0.15 mg for children weighing between 33 and 66 pounds (15 to 30 kilograms) and AUVI-q 0.1 mg for infants and toddlers weighing 16.5 to 33 pounds (7.5 to 15 kilograms). All doses of AUVI-Q are available through the Direct delivery service or at Walgreens locations nationwide. Eligible, commercially insured patients may pay as little as $0 for AUVI-Q. Through the Kaléo Cares Patient Assistance Program, patients who do not have commercial insurance and who are experiencing financial difficulties may be able to receive AUVI-Q at no cost. Please see additional information on patient eligibility and the terms CM-US-AQ-1577 and conditions at www.auvi-q.com/get-auvi-q/.

“We are proud to be working with the food allergy community to raise awareness and support parents and caregivers as they prepare for this unprecedented and unpredictable school-year as anaphylaxis can happen anywhere and at any time,” said Omar Khalil, General Manager, Allergy and Pediatrics, Kaléo. “AUVI-Q has a voice instruction system that helps guide users step-by-step through the administration process and is pocket-sized so it’s designed to be easy to carry.”

AUVI-Q is a prescription medicine approved by the FDA to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. Anaphylaxis is a serious allergic reaction that can happen quickly and may cause death.7 Anaphylaxis can occur from exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.8,9,10 AUVI-Q does not take the place of emergency medical care. Patients need to seek immediate medical treatment after using AUVI-Q.

To learn more about AUVI-Q and to view resources on preparing for the back to school season, please visit www.auvi-q.com.

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References

1. National Center for Education Statistics (NCES). Back to School Statistics. Retrieved July 13, 2020, from https://nces.ed.gov/fastfacts/display.asp?id=372

2. Gupta RS, et al. The public health impact of parent-reported childhood food allergies in the united states. Pediatrics. 2018;142(6):e20181235.

3. Centers for Disease Control and Prevention. Food Allergies. Retrieved July 29, 2020, from https://www.cdc.gov/healthyschools/foodallergies/index.htm.

4. American Academy of Pediatrics (AAP). Back to School, Back to the Doctor. Retrieved July 29, 2020, from https://www.healthychildren.org/English/ages-stages/gradeschool/school/Pages/Back-to-School-Back-to-the-Doctor.aspx

5. American Academy of Pediatrics. Survey: Pandemic disrupting practices, finances of early, midcareer pediatricians. Retrieved July 29, 2020, from https://www.aappublications.org/news/2020/05/21/research052120

6. Centers for Disease Control and Prevention (CDC). Considerations for Schools. Retrieved July 29, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools.html

7. Food Allergy Research and Education. Facts and Statistics. Retrieved July 29, 2020, from https://www.foodallergy.org/life- with-food-allergies/food-allergy-101/facts-and-statistics.

8. Gupta RS, Warren CM, Smith BM, et al. Prevalence and severity of food allergies among US adults. JAMA Netw Open. 2019 Jan 4;2(1):e185630.

9. Golden D. Stinging insect allergy. Am Fam Physician. 2003;67(12):2541-2546.

10. Kelly K, Kurup V, Reijula K. The diagnosis of natural rubber latex allergy. J Allergy Clin Immunol. 1994;93(5):813-816.

Indication

AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. CM-US-AQ-1577

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.

About Kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions that can help empower patients with certain serious and life-threatening medical conditions. We believe patients and caregivers are the experts on how medical conditions impact their lives, and so we include them as an integral part of our development process and consider their needs foremost. Kaléo products combine established drugs with innovative delivery platforms. Kaléo is a privately-held company headquartered in Richmond, Virginia in the United States. For more information, visit www.kaleo.com.

About AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)

AUVI-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat emergency CM-US-AQ-1577

allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a first-line treatment for allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it, incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg) visit www.auvi-q.com.