Auvi-Q

Generic Name: epinephrine injection
Date of Approval: August 10, 2012
Company: Sanofi
Treatment for: Life-Threatening Allergic Reactions

FDA Approves Auvi-Q

The U.S. Food and Drug Administration (FDA) has approved Auvi-Q (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. Auvi-Q is the first-and-only compact epinephrine auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.

Auvi-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that may occur as a result of exposure to allergens including nuts, shellfish, dairy, eggs, insect bites, latex and medication, among other allergens.

About Auvi-Q

Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi-Q is the size and shape of a credit card, the thickness of a cell phone and fits comfortably in a pocket or small purse.

During a life-threatening allergic reaction, Auvi-Q talks the user through each step of the injection process. If the patient or caregiver needs more time, it repeats the step-by-step directions. Alternatively, a patient or caregiver can move at their own pace by following the written instructions printed on the device.

Slideshow: It’s Buggin’ Me! How to Safely Use an Insect Repellent

Auvi-Q provides users with audible and visual cues, including a five-second injection countdown and an alert light to signal when the injection is complete. In addition to being an auto-injector, Auvi-Q features an automatic retractable needle mechanism to help prevent accidental needle sticks.

Available in two different dosages, Auvi-Q 0.3mg delivers 0.3mg epinephrine injection and is intended for patients who weigh 66 pounds or more. Auvi-Q 0.15mg delivers 0.15mg epinephrine injection and is intended for patients who weigh 33 – 66 pounds. Auvi-Q has not been studied in patients weighing less than 33 pounds. Each Auvi-Q pack contains two devices - containing one dose of epinephrine each - and a non-active training device.

Important Safety Information

Auvi-Q (epinephrine injection, USP) is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure, and heart disease.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.

Auvi-Q Patient Information

Read this Patient Information Leaflet before you have to use Auvi-Q and each time you get a refill. There may be new information. You should know how to use Auvi-Q before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Auvi-Q?

  1. Always carry Auvi-Q with you because you may not know when a life-threatening allergic reaction (anaphylactic reaction) may happen. Talk to your doctor if you need additional units to keep at work, school, etc. An anaphylactic reaction is a life-threatening allergic reaction that can happen within minutes and can be caused by stinging and biting insects (bees, wasps, hornets, and mosquitoes), allergy shots, foods, medicines, exercise, or other unknown causes. Follow your healthcare provider’s instructions on when to use Auvi-Q if you have the symptoms of an anaphylactic reaction, which may include the symptoms listed below:
    • trouble breathing
    • wheezing
    • hoarseness (changes in the way your voice sounds)
    • hives (raised reddened rash that may itch)
    • severe itching
    • swelling of your face, lips, mouth or tongue
    • skin rash, redness, or swelling
    • fast heartbeat
    • weak pulse
    • feeling very anxious
    • confusion
    • stomach pain
    • losing control of urine or bowel movements
    • dizziness or fainting
  2. Tell your family members and others where you keep Auvi-Q and how to use it before you need it. You may be unable to speak in an allergic emergency.
  3. Get medical attention immediately after using Auvi-Q. If you have a serious allergic reaction, you may need more medicine.

What is Auvi-Q?

Auvi-Q 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.Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using Auvi-Q.

It is not known if Auvi-Q is safe and effective in children who weigh less than 33 pounds (15 kg).

Before using Auvi-Q

Before you use Auvi-Q, tell your healthcare provider if you:

  • have heart problems or high blood pressure
  • have diabetes
  • have thyroid problems
  • have history of depression
  • have Parkinson’s disease
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Auvi-Q will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Auvi-Q passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Auvi-Q and other medicines may affect each other, causing side effects. Auvi-Q may affect the way other medicines work, and other medicines may affect how Auvi-Q works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Auvi-Q?

  • Each Auvi-Q contains only one dose of medicine.
  • Auvi-Q should only be injected into the muscle of your outer thigh. It can be injected through your clothing, if needed
  • Read the Instructions for Use included with Auvi-Q for information about the right way to use Auvi-Q.
  • Use Auvi-Q exactly as your healthcare provider tells you to use it.
  • An Auvi-Q Trainer with a separate Trainer Instructions for Use leaflet is included with Auvi-Q. Additional training resources are available at www.auvi-q.com.
    • Practice with the Auvi-Q Trainer before an allergic emergency happens to make sure you are able to safely use the real Auvi-Q in an emergency.
    • The Auvi-Q Trainer does not contain a needle or medicine and can be reused to practice your injection.

Auvi-Q side effects

Auvi-Q may cause serious side effects.

  • Auvi-Q should only be injected into your outer thigh. Do not inject Auvi-QTM into your:
    • veins
    • buttocks
    • fingers, toes, hands or feet

If you accidentally inject Auvi-Q into any other part of your body, go to the nearest hospital emergency room right away.

Tell the healthcare provider where on your body you received the accidental injection.

  • 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. Talk to your healthcare provider about all your medical conditions.

Common side effects of Auvi-Q include:

  • fast, irregular, or ‘pounding’ heart beat,/li>
  • sweating
  • shakiness
  • headache
  • paleness
  • feelings of over excitement, nervousness, or anxiety
  • weakness
  • dizziness
  • nausea and vomiting
  • breathing problems

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Auvi-Q. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Auvi-Q?

  • Store Auvi-Q at 68° to 77°F (20° to 25°C).
  • Do NOT expose to extreme heat or cold. For example, do NOT store in your vehicle’s glove box. Do not store Auvi-Q in the refrigerator or freeze.
  • Examine contents in the viewing window periodically. Solution should be clear. If the solution is discolored (pinkish color or darker than slightly yellow), cloudy or contains solid particles, replace the unit.
  • Your Auvi-Q has an expiration date. Replace it before the expiration date.
  • Keep Auvi-Q in the outer case it comes in to protect it from light.

Keep Auvi-Q and all medicines out of the reach of children.

General information about the safe and effective use of Auvi-Q

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Auvi-Q for a condition for which it was not prescribed. Do not give Auvi-Q to other people, even if they have an allergic reaction or the same symptoms that you have. It may harm them.

This Patient Information Leaflet summarizes the most important information about Auvi-Q. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Auvi-Q that is written for health professionals.

For more information and video instructions on the use of Auvi-Q, go to www.auvi-q.com or call 1-800-633-1610.

What are the ingredients in Auvi-Q?

Active ingredient: epinephrine.

Inactive Ingredients: sodium chloride, sodium bisulfite, hydrochloric acid, and water.

Auvi-Q does not contain latex.

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