We also share information about your use of our site with analytics partners. Uncover why Kaleo Pharma is the best company for you. Please see the full Prescribing Information and the Patient Information at www.auvi-q.com. AUVI-Q should only be injected into your outer thigh, ... Kaléo is a new type of 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. – 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 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 . We also share information about your use of our site with analytics partners. Because we respect your right to privacy, you can choose not to allow some types of cookies. 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. You can set your browser to block or alert you about these cookies, but then some parts of the site will not work. For information and an application for the “Q Your School” program, please visit https://kaleo.com/who-we-are/kaleo-cares/. ... "After regaining the rights to Auvi-Q, Kaleo conducted a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product. Some of these infections can be serious. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. To learn more about AUVI-Q (0.15 mg and 0.3 mg), please visit www.auvi-q.com. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. This information might be about you, your preferences, or your device and is mostly used to make the site work as you expect it to. Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. 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. For more information, visit staging.kaleopharma.com. Kaléo has sufficient supply to meet any anticipated demand. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Each AUVI-Q contains a single dose of epinephrine. Through the Kaléo Cares Product Donation Program, qualified applicants may apply to receive up to four AUVI-Q cartons (each carton contains two epinephrine auto-injectors and a Trainer) per school per academic year, free of charge. The new program, “Q Your School,” provides up to four AUVI-Q cartons (each carton contains two epinephrine auto-injectors and a Trainer) per school per academic year, as well as access to educational materials on how to identify and respond to life-threatening allergic emergencies. Meanwhile, the Auvi-Q problem will now be Kaleo's to deal with--and it's one that McLaughlin is not yet sure the Richmond, VA-based company wants to take on. Under Kaléo’s pricing strategy, Auvi-Q will cost most patients $0 out-of-pocket. Eligible, commercially insured patients may pay as little as $0 for AUVI-Q. 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. 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. These cookies do not store any personally identifiable information. For more information, visit www.kaleo.com. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. Some of these infections can be serious. 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). Mylan’s EpiPen is widely used to address severe allergic attacks. It is an epinephrine auto-injector that features voice instructions that help guide a user step by step through the epinephrine delivery process. All information these cookies collect is aggregated and therefore anonymous. AUVI-Q (0.15 mg and 0.3 mg) is a FDA-approved 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. 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. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process. 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. 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. 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. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You are encouraged to report negative side effects of prescription drugs to the FDA. “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. Seek immediate medical treatment after using AUVI-Q. The US firm announced it would relaunch Auvi-Q early next year. Seek immediate medical treatment after using AUVI-Q. 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. These cookies do not store any personally identifiable information. Please see full Prescribing Information at www.auvi-q.com Ask your doctor if AUVI-Q is right for you. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Though the drug-device combination comes at a list price of $4,900, far surpassing the $300 Mylan is charging for its generic EpiPen, Kaleo contends that many patients can get its product free of charge — or at least for $360 cash. “This is an exciting announcement because it helps schools to be more aware of the various epinephrine auto-injector options now available to students at risk for a life-threatening allergic emergency and know how to use them in an emergency.”. For more information about AUVI-Q (0.15 mg and 0.3 mg) visit www.auvi-q.com. The product – which is used to treat severe allergic reactions – was recalled last November over concerns it could potentially deliver the incorrect dose.. Sanofi handed back rights to the product to Kaleo in February and terminated a co-marketing deal it had with PDL Biopharma. Seek immediate medical treatment after using AUVI-Q. The French pharma pulled out of the partnership once the auto-injector was taken off the market. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. Click "Cookie Settings" to update your personal cookie preferences or review our. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Auvi-Q is set to launch next month. 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. Each AUVI-Q contains a single dose of epinephrine. Compare pay for popular roles and read about the team’s work-life balance. Formerly partnered with Sanofi, Auvi-Q injectors were taken off the market in late 2015 due to "i naccurate dosage delivery, which may include failure to deliver drug," according to a statement from Sanofi. INDICATION. You can set your browser to block or alert you about these cookies, but then some parts of the site will not work. Watch to see how kaléo’s values and product development apply this patient-centric mission in order to solve some of the largest health challenges facing this country. If you accidentally inject AUVI-Q into any other part of your body, seek immediate medical treatment. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. Click "Cookie Settings" to update your personal cookie preferences or review our. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in, or filling in forms. In February 2019, a Sandoz customer contacted the pharma to inform them symjepi.net had redirected them to Auvi-Q, the complaint states. Find out what works well at Kaleo Pharma from the people who know best. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Seek immediate medical treatment after use. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Kaleo Pharma set the list price of Auvi-Q at $4,500 — higher than Mylan's EpiPen — even as it promises low costs for patients. IMPORTANT SAFETY INFORMATION Yet Kaleo's deal with Walgreens is, in many ways, the first concrete indication Auvi-Q is gaining some traction in the epinephrine market. AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. 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 … Watch to see how kaléo’s values and product development apply this patient-centric mission in order to solve some of the largest health challenges facing this country. 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.