AUVI-Q® (epinephrine injection, USP) is designed to help give your patients* with life-threatening allergies, or whoever is caring for them, the ability to respond with epinephrine during anaphylaxis. Always avoid allergens, understand the symptoms of anaphylaxis, carry AUVI-Q, and seek emergency medical treatment after using AUVI-Q.
It is not known if AUVI-Q is safe and effective in children weighing less than 16.5 lbs (7.5 kg).
AUVI-Q® (epinephrine injection, USP) is designed to help in the moment of need.
AUVI-Q is about the size of a credit card and thickness of a cell
phone and fits into most pockets and small purses.
AUVI-Q includes innovative features such as voice instructions.
AUVI-Q is the first and only epinephrine auto-injector with an auto-
retractable needle. Patients may not feel an injection when it occurs.
Each prescription pack—both AUVI-Q 0.3 mg and AUVI-Q 0.15 mg—comes with 2 AUVI-Q devices and a Trainer.17
The out-of-pocket cost to your commercially insured patients is no cost at all through the direct delivery service.
Those with commercial insurance,
including those with high-deductible plans, pay $0 out of pocket when they obtain AUVI-Q through the direct delivery service.
(Terms and Conditions)
Those without government or commercial insurance
who cannot afford their medicines may be eligible for support.
(Terms and Conditions)
To be eligible for $0 out of pocket, commercially insured patients must be prescribed AUVI-Q through the direct delivery service, done either in your EMR system or by faxing in the completed enrollment form.
We continually strive to manufacture AUVI-Q with the highest standards in safety, precision, and consistent quality.
AUVI-Q is manufactured on an intelligent, high-tech, 100% automated robotic production line with over 100 automated quality checks on each AUVI-Q device, ensuring a streamlined and consistent production process. The automated robotic production line helps produce a consistent, high-quality product.
The AUVI-Q manufacturing process uses specially calibrated sensors and vision inspection systems to help ensure each component is assembled into AUVI-Q with precision. Every component built into each AUVI-Q has an identifier and is tracked throughout the manufacturing process.
The size of a credit card and thickness of a cell phone, AUVI-Q fits in most pockets and small purses.
Get to know the AUVI-Q voice.
AUVI-Q contains an electronic voice instruction system to help guide users through the entire epinephrine injection.7
A 2-second countdown begins after AUVI-Q is activated. Voice instructions will indicate the injection is complete, AUVI-Q will beep, and the lights will blink red. After use, seek immediate medical attention.7
A closer look at the first and only automatic needle retraction system.
The AUVI-Q auto-retractable needle is not visible before, during, or after injection, and completes epinephrine injection in seconds.†
†Epinephrine injection is complete in less than half a second. However, users must press and hold for a complete 2-second count.
To minimize the risk of injection-related injury when administering AUVI-Q to young children and infants, the prescribing information instructs caregivers to hold the child's leg firmly in place and limit movement prior to and during injection.17
Developed by Patients, for Patients®
AUVI-Q was developed by twin brothers who grew up with life-threatening allergies, and was designed using Human Factors Engineering. Human Factors Engineering places the patient and caregiver at the center of the development process in order to design products that are easy to operate, and most importantly, help support correct and safe use.
AUVI-Q® (epinephrine injection, USP) is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to allergens, idiopathic and exercise-induced anaphylaxis. AUVI-Q is intended for patients with a history of anaphylactic reactions or who are at increased risk for anaphylaxis.
Important Safety Information
AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Each AUVI-Q contains a single dose of epinephrine for single-use injection. More than two sequential doses of epinephrine should only be administered under direct medical supervision. Since the doses of epinephrine delivered from AUVI-Q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary.
AUVI-Q should ONLY be injected into the anterolateral aspect of the thigh. Do not inject intravenously, or into buttock, digits, hands, or feet. Instruct caregivers to hold the leg of young children and infants firmly in place and limit movement prior to and during injection to minimize the risk of injection-related injury.
Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop 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.
Epinephrine should be administered with caution to patients with certain heart diseases, and in patients who are on medications that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease or taking cardiac glycosides or diuretics. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Common adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
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.
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All patients with commercial insurance, including those with high deductible plans, can get AUVI-Q® (epinephrine injection, USP) in 2 easy steps through the direct delivery service. To get started, simply download and fill out your information, then bring the form to your physician to complete.
(Terms and Conditions)
Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107(1):191- 193.
Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med. 1992;327(6):380-384.7
Bock SA, Muñoz-Furlong A, Sampson HA. Further fatalities caused by anaphylactic reactions to food, 2001-2006. J Allergy Clin Immunol. 2007;119(4):1016- 1018.
Kim H, Fischer D. Anaphylaxis. Allergy Asthma Clin Immunol. 2011;7(Suppl 1):S1-S6
Pumphrey RS. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy. 2000;30(8): 1144-1150.
NIAID-Sponsored Expert Panel; Boyce JA, Assa’ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010;126(6 Suppl):S1-58.
McIntyre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. Pediatrics. 2005;116(5):1134-1140.
Sicherer SH, Muñoz-Furlong A, Sampson H. Prevalence of peanut and tree nut allergy in the United States determined by means of a random digit dial telephone survey: A 5-year follow-up study. J Allergy Clin Immunol. 2003;112(6):1203-1207.
Draft Guidance for Industry and Food and Drug Administration Staff. List of Highest Priority Devices for Human Factors Review. U.S. Department of Health and Human Services. Food and Drug Administration. February 2016.
This offer is valid only in the United States. Program is applicable only for commercially insured patients who utilize the direct delivery service. Offer not valid for patients insured in whole or in part by government programs such as Medicaid, Medicare, Tricare or other federal or state health programs (such as state prescription drug programs). If the patient is eligible for benefits under any such program, the patient cannot use this offer. By using this offer, the patient certifies that he or she will comply with any terms of his or her health insurance contract requiring notification to his or her payer of the existence and/or value of this offer. It is illegal to (or offer to) sell, purchase, or trade this offer. This offer is not transferable. Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription(s). Not valid if reproduced. Void where prohibited by law. Program managed by PSKW, LLC on behalf of kaleo, Inc. The parties reserve the right to rescind, revoke, amend, or terminate this offer without written notice at any time. Savings limits apply. Call 1-877-30-AUVIQ for questions regarding eligibility.
Terms and Conditions
THIS OFFER IS NOT INSURANCE.
Call 1-877-30-AUVIQ for questions regarding eligibility. Must be a legal United States Resident. Patient cannot have any commercial or government prescription drug coverage. Patient cannot be eligible for Medicare or Tricare. Patients who are eligible for Medicaid coverage may be eligible for assistance to receive AUVI-Q at no cost. Patient must have an annual household income less than $100,000.
Subject to aggregate and individual volume limitations, availability of AUVI-Q and other terms and conditions. Kaléo reserves the right to discontinue the program at any time for any or no reason.