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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.

Direct delivery service

If you and your doctor determine AUVI-Q is right for you, follow these steps to have your prescription delivered to your home:

DOWNLOAD ENROLLMENT FORM

I am at least 18 years old and I authorize kaléo and its contractors to use, disclose, and/or transfer the personal information I supply (1) to contact me and provide me with informational and marketing materials and clinical trial opportunities related to my condition or treatment by any means of communication, including but not limited to text, e-mail, mail, or telephone; (2) to help kaléo improve, develop, and evaluate products, services, materials and programs related to my condition or treatment; (3) to enroll me in and provide me with AUVI-Q related programs and services that I may select or refuse at any time; (4) to disclose my enrollment and use of these services to my healthcare providers and insurers; and (5) to use my information that cannot identify me for scientific and market research.

To learn more about the kaléo Privacy Policy, click here.

To cancel or request a copy of this authorization, please contact us at 1-877-30-AUVIQ. I understand that if I cancel I may not be entitled to receive AUVI-Q related programs and services.

This information is provided for general education purposes only. Please consult with your healthcare professional about any questions about your health or treatment.

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PROCEED

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:

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

PATIENT ASSISTANCE FORM

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.

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 that patients 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.

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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. Limit one (1) carton of AUVI-q 0.1 mg per patient each calendar year. Limit two (2) cartons of AUVI-Q 0.15 mg or 0.3 mg per patient each calendar year. Individual insurance plans may impose additional requirements that affect the redemption of the offer and out-of-pocket costs may vary. 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 844-357-3968 for questions regarding offer eligibility.

Thank you!

We look forward to staying in touch.

AUVI-Q® (epinephrine injection, USP) administers epinephrine in 3 steps.12