References

Ma L, Danoff TM, Borish L. Case fatality and population mortality associated with anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(4):1075-1083.
Motosue M, Bellolio MF, Van Houten HK, Shah ND, Campbell RL. Increasing emergency department visits for anaphylaxis, 2005-2014. J Allergy Clin Immunol Pract. 2017;5(1):171-175.e1-3.
Tang ML, Mullins R. Food allergy: is prevalence increasing? Intern Med J. 2017;47(3):256-261.
Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011;128(1):e9-e17.
Gupta RS, Warren CM, Smith BM, et. al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235.
Clark S, Espinola JA, Rudders SA, Banerji A, Camargo CA Jr. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol. 2010;127(3):682-683.
Clark S, Espinola JA, Ruddesr SA, et al. Favorable trends in the frequency of U.S. emergency department visits for food allergy, 2001-2009. Allergy Asthma Proc. 2013;34(5):439-445.
Michelson K, Monuteaux M, and Neuman M. Variation and trends in anaphylaxis care in United States childrens’ hospitals. Acad Emerg Med. 2016;23(5):623-627.
Tiyyagura GK, Arnold L, Cone DC, Langhan M. Pediatric anaphylaxis management in the prehospital setting. Author manuscript published by the National Institutes of Health, Public Access, PMC January 1, 2015;1-11. Published in final edited form in Prehosp Emerg Care. 2014;18(1):46-51.
Radke TJ, Brown LG, Hoover ER, et al. Food allergy knowledge and attitudes of restaurant managers and staff: an EHS-NET study. Author manuscript published by the Department of Health and Human Services, Public Access, PMC February 23, 2017;1-24. Published in final edited form in J Food Prot. 2016;79(9):1588-1598
Wahl A, Stephens H, Ruffo M, Jones AL. The evaluation of a food allergy and epinephrine autoinjector training program for personnel who care for children in schools and community settings. J Sch Nurs. 2015;31(2):91-98.
Robinson M, Greenhawt M, Stukus D. Factors associated with epinephrine administration for anaphylaxis in children before arrival to the emergency department. Ann Allergy Asthma Immunol. 2017;119:164-169.
Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107(1):191-193.
Allen K, Henselman K, Laird B, Quiñones A, Reutzel T. Potential life-threatening events in schools involving rescue inhalers, epinephrine autoinjectors, and glucagon delivery devices: reports from school nurses. J Sch Nurs. 2012;28(1):47-55.
Young M, Muñoz-Furlong A, Sicherer S. Management of food allergies in schools: a perspective for allergists.J Allergy Clin Immunol. 2009;124(2):175-182.
Kim H, Fischer D. Anaphylaxis. Allergy Asthma Clin Immunol. 2011;7(Suppl 1):S6.
Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis—a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015;115:341-348.
Fleming JT, Clark S, Camargo CA, Rudders SA. Early treatment of food-induced anaphylaxis with epinephrine is associated with a lower risk of hospitalization. J Allergy Clin Immunol Pract. 2015;57-62.
Sicherer SH, Simons FER; Section on Allergy and Immunology. Epinephrine for first-aid management of anaphylaxis. Pediatrics. 2017;139(3):e1-11.
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.
Yunginger JW, Sweeney KG, Sturner WQ, et al. Fatal food-induced anaphylaxis. JAMA. 1988;260(10):1450-1452.
Hochstadter E, Clarke A, De Schryver S, et al. Increasing visits for anaphylaxis and the benefits of early epinephrine administration: a 4-year study at a pediatric emergency department in Montreal, Canada. J Allergy Clin Immunol. 2016;137(6):1888-1890.
AUVI-Q [Prescribing Information]. Richmond, VA: kaleo Inc.; 2017.
Edwards ES, Edwards ET, Gunn R, Patterson P, North R. Design validation and labeling comprehension study for a new epinephrine autoinjector. Ann Allergy Asthma Immunol. 2013;110(3):189-193.
Camargo CA Jr., Guana A, Wang S, Simons FER. Auvi-Q versus EpiPen: preferences of adults, caregivers, and children. J Allergy Clin Immunol Pract. 2013;1(3):266-272.e1-e3.
Warren CM, Zaslavsky JM, Kan K, Spergel JM, Gupta RS. Epinephrine auto-injector carriage and use practices among US children, adolescents, and adults. Ann Allergy Asthma Immunol. doi:10.1016/j.anai.2018.06.010.
Guerlain S, Wang L, Hugine A. Intelliject’s novel epinephrine autoinjector: sharps injury prevention validation and comparable analysis with EpiPen and Twinject. Ann Allergy Asthma Immunol. 2010;105(6):480-484.
Wang J, Bingemann T, Russel AF, et al. The allergist’s role in anaphylaxis and food allergy management in the school and childcare setting.J Allergy Clin Immunol Pract. 2017;6(2)1-9.
Blue Cross Blue Shield Association (BCBSA). The Health of America Report. Childhood allergies in America: severe allergic reactions causing more emergency room visits for U.S. children. https://www.bcbs.com/the-health-of-america/reports/childhood-allergies-america. Published March 13, 2018. Accessed January 11, 2019.

AUVI-Q^® (epinephrine injection, USP) administers epinephrine in 3 steps²³

STEP 1

Pull AUVI-Q up from the outer case.

Do not go to step 2 until you are ready to use AUVI-Q. If you are not ready to use AUVI-Q, put it back in the outer case.

STEP 2

Pull red safety guard down and off of AUVI-Q.

To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away.

Note: The red safety guard is made to fit tightly. Pull firmly to remove.

STEP 3

Place black end of AUVI-Q against the middle of the outer thigh, then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds.

AUVI-Q can inject through clothing if necessary. ONLY inject into the middle of the outer thigh. To minimize the risk of injection-related injury, instruct caregiver to hold a young child’s or infant’s leg firmly in place when administering AUVI-Q.

After use, instruct patient to get emergency help right away.

To minimize the risk of injection-related injury, instruct caregiver to hold a young child’s or infant’s leg firmly in place when administering AUVI-Q.

Terms and Conditions

Only valid for commercially insured patients in the 50 United States and DC through the direct delivery service and/or designated retail pharmacies. Not eligible if prescriptions are paid for in part/full by state or federally funded program(s), like Medicare Part D, Medicaid, Vet. Aff., Dept. of Def., or Tricare, and where prohibited by law. OFFER IS NOT INSURANCE. Offer cannot be sold, purchased, traded, transferred, and cannot be combined with any other offer. Cash discount cards are not commercial payers and are not eligible to be used for this program. Offer provided by kaléo, and it may change at any time without notice.

Call 1-877-30-AUVIQ for questions regarding offer eligibility.

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Please understand that AUVI-Q is not responsible for how your information is processed or used on non-AUVI-Q sites. Also note that providing links to non-AUVI-Q sites is not an endorsement of the other site by AUVI-Q or any of its employees. And finally, be aware that the privacy protection provided on our site may not be available on an external link.

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Pricing Philosophy for AUVI-Q^® (epinephrine injection, USP)

As a company founded by patients with life-threatening allergies, we take our commitment to the needs of patients and their families very seriously. In this era of high deductible health plans, many patients find it harder than ever to afford their medications. We are committed to ensuring thatpatients with commercial insurance, or those facing financial hardship, should be able to obtain our potentially lifesaving products for little to no out-of-pocket cost.

Our Beliefs:
For us, the patient always comes first. We believe the most important price is the price to the patient. We believe that patients with life-threatening conditions deserve fair access to the latest medicines that offer technological innovations that address their medical needs. We believe that when a healthcare practitioner prescribes AUVI-Q, patients should be able to fill their prescription without high out-of-pocket costs.

Our Commitment to Access and Affordability:
We have seen firsthand in this current healthcare system the very real challenges patients are facing in being able to access and afford potentially lifesaving medicines. Similar to our product innovation process, our AUVI-Q patient access program has been built to solve for some of these challenges and help focus on what matters most... access and affordability to AUVI-Q for patients.

Our Commitment to AUVI-Q Manufacturing and Quality:
Kaléo is committed to the highest standards of product and manufacturing quality. Final manufacturing and assembly of AUVI-Q is conducted in the United States on a 100% automated robotic production line with more than 100 automated quality checks on each and every product.

Patients can be confident in our approach to design quality into AUVI-Q and incorporate quality into every aspect of the manufacturing process.

kaléo Cares Patient Assistance Program

Kaléo, the maker of AUVI-Q, understands the importance of having emergency medications available to patients. We also recognize that some patients may have financial difficulties that prevent them from obtaining these needed medications.

Through the kaléo Cares Patient Assistance Program, patients who are experiencing financial difficulties may be able to receive AUVI-Q at no cost.

To be eligible for assistance, a patient must:

Be a legal US resident.
Not have any government or commercial drug coverage.
Have an annual household income of less than $100,000.

Patients who are eligible for Medicaid coverage may be eligible for assistance to receive AUVI-Q at no cost.

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Indication
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.

Please see the full Prescribing Information and the Patient Information.

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.

ANAPHYLAXIS

Anaphylaxis is on the rise1-3

The number of anaphylactic events in the United States has risen in recent years, including among infants and toddlers.1-3

It is estimated that about 6 million children have food allergies.4,5

Hospitalizations from anaphylaxis rose from 21.0 to 25.1 per million population between 1999 and 2009.1

Food-related allergic emergencies send someone to the hospital on average every 3 minutes.6,7

At children’s hospitals in the United States, emergency department visits for anaphylaxis increased more than 2X between 2009 and 2013.8

Where will your patient be when anaphylaxis occurs?

Allergic emergencies often happen outside the comfort and familiarity of home, in places like9-13:

People with little or no prior training may be called upon to administer epinephrine.11,14,15

According to a survey of 2040 school nurses, staff that may be allowed to administer epinephrine include14:

Immediate treatment with epinephrine is the standard of care for anaphylaxis16-18

Delayed epinephrine administration in anaphylaxis is associated with an increased risk of hospitalization and poor outcomes including death.13,18-21

What might stop your patients from using their epinephrine auto-injector during anaphylaxis?

A Canadian study of 965 cases of anaphylaxis (median age 5.8 years) showed only 51% of patients who had an epinephrine auto-injector used it before arrival to the emergency department.22

Discover the features of AUVI-Q® (epinephrine injection, USP) to see how it fits in the lives of your patients with life-threatening allergies.

ABOUT AUVI-Q® (epinephrine injection, USP)

Innovative voice instructions

AUVI-Q features a voice-instruction system to guide users step by step through an injection.23 It even reminds the patient to call 911.

In a simulated use study scenario, participants (n=693) were 2x more likely to correctly complete all the steps of the injection protocol with AUVI-Q vs Epipen® (epinephrine injection, USP).25

CONVENIENT POCKET SIZE

AUVI-Q was designed with size in mind, and is about the size of a credit card and thickness of a cell phone.

Are your patients among those who fail to carry their epinephrine with them at all times?12,15,26

In a study of 693 participants, AUVI-Q was significantly (P<0.001) preferred over EpiPen® (epinephrine injection, USP) in 2 key measures.25

Auto-retractable needle

Take a closer look at the first and only epinephrine auto-injector with an automatic needle retraction system.23

With the auto-retractable needle epinephrine is delivered in less than half a second. However, users must push firmly and hold for a complete 2-second count.23

Purposeful design

AUVI-Q administration in 3 steps23

Watch a simulated injection of AUVI-Q:

MEET THE AUVI-Q FAMILY

AUVI-Q is available in 3 strengths

AUVI-q 0.1 mg is the first and only FDA-approved epinephrine auto-injector designed specifically for infants and toddlers weighing 16.5 lbs to 33 lbs.23

AUVI-q 0.1 mg was designed with the same easy-to-use features as the rest of the product family.

MADE WITH CARE

Every AUVI-Q is manufactured according to the highest standards.

How it's made:

Developed by Patients, for Patients®

AUVI-Q was developed by twin brothers who grew up with life-threatening allergies and made it their mission to bring innovation to the epinephrine auto-injector market.

Is AUVI-Q a good fit for your practice?

PRESCRIBING

e-Prescribe in 3 steps

If you’ve decided AUVI-Q® (epinephrine injection, USP) is right for your commercially insured patients, getting it to them is easy through the direct delivery service. Prescribe AUVI-Q, then follow these three simple steps:

SELECT ASPN

ADD MEDICAL HISTORY

SEND PRESCRIPTION

Patient access

Eligible patients with commercial insurance pay $0 out of pocket when they obtain AUVI-Q through the direct delivery service.*

Once you’ve written the prescription, here’s what to expect

With direct delivery service, AUVI-Q is shipped directly to your patient’s home to ensure the best expiration dating.

Let your patients know:

Kaléo Cares Patient Assistance

Those without government or commercial insurance who cannot afford their medicines may qualify for support through the kaléo Cares Patient Assistance Program.

RESOURCES

FORMS

References

AUVI-Q® (epinephrine injection, USP) administers epinephrine in 3 steps23

STEP 1

Pull AUVI-Q up from the outer case.

STEP 2

Pull red safety guard down and off of AUVI-Q.

STEP 3

Place black end of AUVI-Q against the middle of the outer thigh, then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds.

Terms and Conditions

You are leaving www.auvi-q.com

Pricing Philosophy for AUVI-Q® (epinephrine injection, USP)

kaléo Cares Patient Assistance Program

Anaphylaxis is on the rise^1-3

The number of anaphylactic events in the United States has risen in recent years, including among infants and toddlers.^1-3

It is estimated that about 6 million children have food allergies.^4,5

Hospitalizations from anaphylaxis rose from 21.0 to 25.1 per million population between 1999 and 2009.¹

Food-related allergic emergencies send someone to the hospital on average every 3 minutes.^6,7

At children’s hospitals in the United States, emergency department visits for anaphylaxis increased more than 2X between 2009 and 2013.⁸

Allergic emergencies often happen outside the comfort and familiarity of home, in places like^9-13:

People with little or no prior training may be called upon to administer epinephrine.^11,14,15

According to a survey of 2040 school nurses, staff that may be allowed to administer epinephrine include¹⁴:

Immediate treatment with epinephrine is the standard of care for anaphylaxis^16-18

Delayed epinephrine administration in anaphylaxis is associated with an increased risk of hospitalization and poor outcomes including death.^13,18-21

A Canadian study of 965 cases of anaphylaxis (median age 5.8 years) showed only 51% of patients who had an epinephrine auto-injector used it before arrival to the emergency department.²²

Discover the features of AUVI-Q^® (epinephrine injection, USP) to see how it fits in the lives of your patients with life-threatening allergies.

ABOUT AUVI-Q^®
(epinephrine injection, USP)

AUVI-Q features a voice-instruction system to guide users step by step through an injection.²³ It even reminds the patient to call 911.

In a simulated use study scenario, participants (n=693) were 2x more likely to correctly complete all the steps of the injection protocol with AUVI-Q vs Epipen^® (epinephrine injection, USP).²⁵

Are your patients among those who fail to carry their epinephrine with them at all times?^12,15,26

In a study of 693 participants, AUVI-Q was significantly (P<0.001) preferred over EpiPen^® (epinephrine injection, USP) in 2 key measures.²⁵

Take a closer look at the first and only epinephrine auto-injector with an automatic needle retraction system.²³

With the auto-retractable needle epinephrine is delivered in less than half a second. However, users must push firmly and hold for a complete 2-second count.²³

AUVI-Q administration in 3 steps²³

AUVI-q 0.1 mg is the first and only FDA-approved epinephrine auto-injector designed specifically for infants and toddlers weighing 16.5 lbs to 33 lbs.²³

Developed by Patients, for Patients^®

If you’ve decided AUVI-Q^® (epinephrine injection, USP) is right for your commercially insured patients, getting it to them is easy through the direct delivery service. Prescribe AUVI-Q, then follow these three simple steps:

AUVI-Q^® (epinephrine injection, USP) administers epinephrine in 3 steps²³

Pricing Philosophy for AUVI-Q^® (epinephrine injection, USP)