Kaléo Confirms U.S. Availability of AUVI-Q® (epinephrine injection, USP) Auto-injector for Back-to-School Season

- AUVI-Q is not affected by the manufacturing delays reported to the FDA by other epinephrine auto-injector manufacturers

- 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

News provided by

Kaléo

Aug 14, 2018, 08:01 ET

RICHMOND, Va., Aug. 14, 2018 /PRNewswire/ -- Kaléo, a privately-held pharmaceutical company, today commented on reports of continued manufacturing delays of epinephrine auto-injectors in the United States. Kaléo confirmed that AUVI-Q^® (epinephrine injection, USP) Auto-injectors are available for prescription and are not affected by the manufacturing delays reported by other epinephrine auto-injector manufacturers. Kaléo has sufficient supply to meet any anticipated demand. For live assistance in filling an AUVI-Q prescription, any patient, physician or pharmacist in the United States can call the AUVI-Q hotline at 1-877-30-AUVI-Q or visit www.auvi-q.com to download an enrollment form.

"We understand how critically important it is for those affected by life-threatening allergies to be able to access an epinephrine auto-injector, especially as families prepare for the back to school season. Kaléo is able to fill, and is filling, all the AUVI-Q orders through our Direct Delivery service at www.auvi-q.com," said Phil Rackliffe, General Manager of Allergy and Pediatrics, at kaléo. "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."

AUVI-Q is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. Its 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.

Identical twin brothers, Eric and Evan Edwards, the inventors of AUVI-Q, grew up with life-threatening allergies. They know what it is like to live in fear of that life-or-death moment, both as patients and parents of food-allergic children. Eric and Evan Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency. AUVI-Q does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q.

Through the AUVI-Q AffordAbility program, patients with commercial insurance, even those with high-deductible plans, as well as the uninsured who have a household income of less than $100,000, can obtain AUVI-Q for $0 out of pocket. The cash price for AUVI-Q is $360. Each AUVI-Q prescription includes two Auto-injectors and one Trainer.

The latest information regarding epinephrine auto-injectors experiencing manufacturing delays, as well as related advisories to patients and healthcare providers around epinephrine auto-injectors at home, is listed on the FDA drug shortage webpage.

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

About Anaphylaxis

Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. 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.

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 life-threatening 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 well-established, first-line treatment for severe, life-threatening 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.

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.

About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions. Our mission is to provide innovative solutions that empower patients to confidently take control of their 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.

Contact: Mark A. Herzog
Kaléo
[email protected]
[email protected]
804-545-6360 (office)

SOURCE Kaléo