News

Kaléo Redesigns Commercial Team to Increase Support for AUVI-Q® (epinephrine injection, USP)

Richmond, Virginia (October 1, 2024) – Kaléo, a privately-held U.S. pharmaceutical company has announced a redesign of the AUVI-Q® (epinephrine injection, USP) commercial team structure to increase in-office support for healthcare providers. AUVI-Q is a prescription medicine used to treat emergency allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions.

“This enhanced commercial structure for AUVI-Q will double the number of representatives providing in-office support to healthcare providers as well as expand our pharmacy support team to ensure providers and patients have easy access to our affordability programs,” said Kaléo Chairman and Chief Executive Officer, Michael Wells. “Increased access to AUVI-Q is important for the 33 million Americans affected by food allergies as it is the only epinephrine product available in three doses for the treatment of anaphylaxis in adults, children, and infants.”

AUVI-Q is about the size of a credit card and thickness of a smartphone and is the only epinephrine product with calm, voice instructions to help guide users through the administration process. 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).

While food allergies can be diagnosed at any age, most appear in early childhood^1,2 and the AUVI-q 0.1 mg dose is the only FDA approved epinephrine product for infants and toddlers.

AUVI-Q is available to most commercially insured patients for $35 or less while patients with high-deductible plans or without AUVI-Q coverage will pay no more than $150 through ASPN Pharmacies. Patients who do not have commercial insurance and who are experiencing financial difficulties may be able to receive AUVI-Q at no cost through the Kaléo Patient Assistance Program. Additional information on patient eligibility and the terms and conditions can be found at www.auvi-q.com/get-auvi-q/.

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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.

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.

References

1. “Food Allergy.” American College of Allergy, Asthma & Immunology. https://acaai.org/allergies/allergicconditions/food/. Accessed 4 Jan. 2024.

2. Gupta RS, Warren CM, Smith BM, et al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235. doi:10.1542/peds.2018-1235. Available at: https://publications.aap.org/pediatrics/article/143/3/e20183835/37237/Gupta-RS-Warren-CM-Smith-BM-et-al-The-Public

About Kaléo

Kaléo is dedicated to inventing, manufacturing, and commercializing life-transforming products for certain serious and life-threatening medical conditions. With a patient-centric approach and unwavering commitment to quality and advanced manufacturing techniques, Kaléo is a market leader in emergency use auto-injectors. All marketed Kaléo auto-injector products meet the U.S. Food and Drug Administration’s (FDA) draft guidance standard for 99.999% device reliability.  Visit www.kaleo.com to learn more the company’s innovative auto-injection technologies and extensive intellectual property portfolio of ~ 200 patents and patent applications.

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

AUVI-Q (epinephrine injection, USP) is a prescription medicine used to treat emergency 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 visit www.auvi-q.com.

Kaléo Media Contact
Caryn Foster Durham
Senior Director, Corporate Communications, Kaléo
Email: media.inquiries@kaleo.com
Phone: (804) 877-6624