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AUVI-Q is the only epinephrine auto-injector with 3 doses

0.1mg Auvi-q
AUVI-q 0.1 mg
For infants and toddlers1
weighing 16.5 lbs to 33 lbs
See more information on the first and only FDA-approved epinephrine auto-injector for infants and toddlers (weighing 16.5 lbs to 33 lbs)
0.15mg Auvi-Q
AUVI-Q 0.15 mg
For children1
weighing 33 lbs to 66 lbs
0.3mg Auvi-Q
AUVI-Q 0.3 mg
For anyone1
weighing 66 lbs or more
See more information on the first and only FDA-approved epinephrine auto-injector for infants and toddlers (weighing 16.5 lbs to 33 lbs)

Anaphylaxis healthcare costs and resource utilization are growing concerns for payers, HCPs, and patients

chart-icon

National commercial payer claims data indicate a significant healthcare burden associated with food-induced anaphylaxis2-4

See the data for medical costs and claims here.

Real-world evidence supports why AUVI-Q should be covered

Present evidence on the healthcare-economic consequences of patients with anaphylaxis5

Total Cost of Care Breakdown in the Matched Population5

cost breakdown chart cost breakdown chart

Healthcare resource consumption was based on a 3-month episode of care following the index data of the anaphylaxis event.5

The objective of the study was to analyze healthcare resource use and costs of care in non-matched and matched patient populations who experienced anaphylaxis and were previously prescribed AUVI-Q vs other epinephrine auto-injectors (EAIs).5
This study was funded by Kaléo.

Download the study here.

Total costs of care during the 3 month post-index period excluding prescription costs were

$427 less

in the AUVI-Q cohort compared to the other EAI cohort.

Inpatient costs post index were

$162 less

for AUVI-Q patients, which is in line with the fewer hospitalizations observed among AUVI-Q patients.

For more information about AUVI-Q click here.

The importance of device design on successful epinephrine administration

AUVI-Q is designed to be easy to use and easy to carry

VOICE INSTRUCTIONS

POCKET SIZED

AUTO-RETRACTABLE NEEDLE

AUVI-Q voice instructions remind patients to seek emergency medical care after use.

For infants and toddlers weighing 16.5 lbs-33 lbs

AUVI-q 0.1 mg was designed to mitigate the risk of needle injury when administering epinephrine to infants and toddlers 16.5 lbs-33 lbs.

To learn more about AUVI-q 0.1 mg designed for infants and toddlers click here.

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.1

Patients should seek emergency medical care immediately after use.

HEAD-TO-HEAD STUDIES: AUVI-Q vs EPIPEN® (EPINEPHRINE INJECTION, USP)6,7

See the full details of these studies here.

Study 1:

AUVI-Q was easier to use than EpiPen for untrained users6

In a randomized, cross-over usability study, untrained adults aged 18-65 years (N = 96) used 0.15 mg AUVI-Q and EpiPen Jr trainers to simulate epinephrine administration to a child-sized manikin.

The untrained adults had no prior experience with epinephrine auto-injectors and were not provided with the devices prior to starting the simulation.

Significantly more untrained adults completed key injection tasks with AUVI-Q6
Graph showing that more participants completed the AUVI-Q protocol versus EpiPen Jr in a study

Key injection tasks were defined as the minimum tasks required for a patient to receive an epinephrine dose.

As this was a simulated use study, participants may not have experienced the same level of stress that they might experience during anaphylaxis.

Study was conducted by kaleo, Inc.

Study 2:

AUVI-Q was preferred over EPIPEN for both its size and shape7

A study of 693 people aged 11 to 65 years was conducted to determine whether adults (N = 241), caregivers (N = 228), and children (N = 224) with and without EAI experience prefer using the AUVI-Q device compared to the EpiPen.

size and shape of AUVI-Q device

EpiPen® and EpiPen Jr® are registered trademarks of Mylan Inc.

Kaléo IS COMMITTED TO IMPROVING PATIENT ACCESS AND AVAILABILITY TO AUVI-Q

We continue to engage closely with payers and insurance companies to expand formulary access for AUVI-Q. Effective January 2022, the list price for AUVI-Q will be $575.00. Most patients do not pay list price. Out-of-pocket costs may vary based on insurance coverage. Kaléo remains committed to ensuring that eligible patients with commercial insurance, or those facing financial hardship, should be able to obtain AUVI-Q affordably through our access program. For additional questions or information, please contact our market access team at [email protected]

THERE IS A STRONG DEMAND BY HEALTHCARE PROVIDERS AND PATIENTS FOR AUVI‑Q

>2.6 million
AUVI-Q PRESCRIPTIONS written since 2017
#1 prescribed
AUVI-Q is the #1 prescribed epinephrine auto-injector by allergists in the US8

AUVI-Q IS MANUFACTURED IN THE US ACCORDING TO THE HIGHEST STANDARDS

AUVI-Q is the Only Approved Epinephrine Auto-injector to:
  • Never experienced a shortage since Kaléo launched the product, despite having produced ~8 million auto-injectors to date8*
  • Achieve the FDA’s mandated draft guidance of 99.999% manufacturing reliability
  • Have passed all the Department of Defense military standard durability tests
*As of 09/01/2021

WHO CAN I CONTACT IF I HAVE QUESTIONS ABOUT AUVI-Q?

We are available to answer any questions you may have about AUVI-Q.
Please contact us at [email protected]
GET THE INFORMATION YOU NEED FOR AUVI-Q
To learn more about AUVI-Q and receive up-to-date information, please fill out the form below:
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INDICATION and IMPORTANT SAFETY INFORMATION
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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.

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.

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.

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