-- Direct Relief to distribute 25,000 auto-injectors to partner clinics serving storm-impacted communities -- Richmond, VA (September 1, 2017)

Kaléo, a privately-held pharmaceutical company, today announced a donation of 20,000 AUVI-Q® (epinephrine injection, USP) Auto-injectors and 5,000 EVZIO® (naloxone HCl injection) Auto-injectors to medical aid organization Direct Relief in support of Hurricane Harvey relief efforts in Texas, Louisiana and other affected states.

“Tens of thousands of people have had to flee their homes with little more than the clothes on their backs,” said Spencer Williamson, President and CEO of kaléo. “We are proud to work with Direct Relief to ensure that our epinephrine and naloxone products are available to patients in need.”

“We are deeply appreciative for the donation by kaléo and are pleased to work with them to help support the medical needs of the victims of Hurricane Harvey along the Gulf Coast,” said Pat Bacuros, Direct Relief’s Director of Philanthropic Investment. “As the only non-profit medical aid organization to obtain Verified-Accredited Wholesale Distributor status from the National Association of Boards of Pharmacy, Direct Relief is a natural partner for kaléo to get these potentially life-saving medications to those in the greatest need.”

AUVI-Q (0.15 mg and 0.3 mg) 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. EVZIO was the first naloxone product specifically designed, approved and labeled for the emergency treatment of opioid overdose by individuals without medical training. The products are both FDA-approved and have innovative features such as voice instructions that help guide users with step-by-step instructions through the delivery process of the medications. The products also feature an automatic retractable needle system that injects the medication and retracts the needle back into the device within seconds.

“One out of every 13 children in the U.S. has at least one food allergy,” said Dr. James R. Baker, Jr., CEO of Food Allergy Research and Education (FARE). “Therefore, it is likely that there are many children with life-threatening allergies among the flood victims. We are pleased PP-AQ-US-0573 to see efforts to ensure replacement epinephrine to patients who may have lost their autoinjectors in this emergency.”

“I commend Direct Relief and kaléo for taking bold action to help victims of Hurricane Harvey obtain the medicines they need in this crisis,” said Mark Kinzly, Co-founder of the Texas Overdose Naloxone Initiative. “The opioid overdose crisis will not recede during this natural disaster. Having access to naloxone in the affected areas will help save lives.”

“With the devastating situation in Texas and Louisiana due to Hurricane Harvey, and many families there affected by food allergies and life-threatening anaphylaxis, it’s imperative for individuals to have immediate access to potentially life-saving mediciations, including epinephrine,” said Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “Thank you to our partner, kaléo, and to Direct Relief, for providing these auto-injectors for those most in need.”

To learn more about AUVI-Q (0.15 mg and 0.3 mg), please visit www.auvi-q.com. For information about EVZIO, please visit www.evzio.com.

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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 (0.15 mg and 0.3 mg)
AUVI-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat lifethreatening 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 (0.15 mg and 0.3 mg) visit www.auviq.com. PP-AQ-US-0573

AUVI-Q 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.

AUVI-Q 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 use. 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 with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject into veins, buttocks, fingers, toes, hands, or feet. If you accidentally inject AUVI-Q into any other part of your body, seek immediate medical treatment.

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 click here to 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.

To review the full press release, click here.