Walgreens and Kaléo Partner to Address Epinephrine Auto-Injector Supply Issues, Providing Patients Access to AUVI-Q® (epinephrine injection, USP) Through Walgreens Locations Nationwide

DEERFIELD, Ill. & RICHMOND, Va.--(BUSINESS WIRE)-- Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® 0.15 mg and 0.3 mg available through Walgreens locations nationwide. This comes in an effort to help thousands of Americans with their epinephrine needs during the back to school season, as supply issues have been reported to the U.S. Food and Drug Administration (FDA) by other manufacturers.

AUVI-Q is a prescription medicine approved by the FDA to treat emergency allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. AUVI-Q does not take the place of emergency medical care. Patients need to seek immediate medical treatment after using AUVI-Q.

Through the AUVI-Q AffordAbility program provided by kaléo, eligible patients with commercial insurance, even those with high-deductible plans, can obtain AUVI-Q at no cost. For eligible patients who do not have insurance or prescription drug coverage, kaléo may be able to support through its patient assistance program. Please see additional information on patient eligibility and the terms and conditions at www.auvi-q.com/getting-auvi-q/

Anaphylaxis is a serious allergic reaction that happens quickly and may cause death.¹ Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens. Reports estimate that up to 15 million Americans are living with food allergies.²

“The health and wellbeing of our customers is of the upmost importance,” said Richard Ashworth, Walgreens president of operations. “Walgreens pharmacists continue to care for and work with patients and their prescribers to ensure they have access to the epinephrine auto-injectors they need, and we’re pleased to work with kaléo to help meet the demand for epinephrine auto-injectors across the country.”

AUVI-Q’s innovative features include voice instructions that help guide a user step-by-step through the epinephrine delivery process, as well as an auto-retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.

“Thanks to this collaboration with Walgreens, any patient who is having difficulty filling a prescription for an epinephrine auto-injector now has the opportunity to get AUVI-Q through Walgreens,” said Phil Rackliffe, general manager of Allergy and Pediatrics at kaléo. “We are working with insurance providers to maximize coverage of AUVI-Q for as many patients as possible.”

For patients who are unable to fill their current epinephrine prescriptions, Walgreens pharmacists will work with each patient’s healthcare practitioner to see if AUVI-Q is right for them. Current AUVI-Q patients should continue to utilize kaléo’s Direct Delivery service at https://www.auvi-q.com/getting-auvi-q/ to ensure delivery to their home. AUVI-Q 0.15 mg and 0.3 mg are available through Walgreens for patients with commercial insurance. Medicare patients should check with their individual health plan to verify their specific benefits, as AUVI-Q coverage varies by Medicare plan.

To learn more about AUVI-Q, please visit www.auvi-q.com.

References

1. Lieberman, P. (2015). Anaphylaxis After Cystoscopy. The Journal of Allergy and Clinical Immunology: In Practice, 3(3), 469-470. doi:10.1016/j.jaip.2014.05.007

2. Facts and Statistics. Facts and Statistics – Food Allergy Research & Education. https://www.foodallergy.org/facts-and-stats. Accessed September 4, 2018.

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.

About Walgreens

Walgreens (walgreens.com), one of the nation’s largest drugstore chains, is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc. (NASDAQ: WBA), the first global pharmacy-led, health and wellbeing enterprise. Approximately 8 million customers interact with Walgreens in stores and online each day, using the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice. As of June 28, 2018, Walgreens operates approximately 9,800 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands, along with its omnichannel business, Walgreens.com. Approximately 400 Walgreens stores offer Healthcare Clinic or other provider retail clinic services.

About kaléo (kuh-LAY-oh)

Kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives and are an integral part of our product development process. Kaléo is a privately-held company headquartered in Richmond, Virginia. 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 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.

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