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Auvi-Q (Epinephrine): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
0.3 mg/0.3 mL, 0.15 mg/0.15 mL, 0.1 mg/0.1 mL
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Auvi-Q

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

  1. 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 healthcare provider 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. 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. 3. Get medical care for further treatment of the allergic emergency if needed after using AUVI-Q. Before you receive AUVI-Q, your healthcare provider should talk to you about when to get emergency help.

What is AUVI-Q?

  • AUVI-Q is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in adults and children who weigh 16.5 pounds (7.5 kilograms) or more who are at risk for or have a history of serious allergic reactions.
  • AUVI-Q is for immediate self (or caregiver) administration.

It is not known if AUVI-Q is safe and effective in children who weigh less than 16.5 pounds (7.5 kilograms).

What should I tell my healthcare provider before using AUVI-Q?

Before using AUVI-Q, tell your healthcare provider about all of your medical conditions, especially if you:

  • have heart problems or high blood pressure.
  • have diabetes.
  • have thyroid problems.
  • have kidney problems.
  • have history of depression.
  • have Parkinson’s disease.

  • 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?

  • Read the Instructions for Use at the end of this Patient Information leaflet for information about the right way to use AUVI-Q.
  • Use AUVI-Q exactly as your healthcare providers tells you to use it.
  • AUVI-Q should only be injected into your outer thigh. If needed, AUVI-Q can be injected through your clothing.
  • Each AUVI-Q contains only 1 dose of medicine.
  • If a second dose of AUVI-Q is needed, it should be given starting 5 minutes after the first dose.
  • You should always carry 2 AUVI-Q devices with you.
  • If you need more than 2 doses of epinephrine for a single anaphylaxis episode, more doses must be given by a healthcare provider.

  • You may request a Trainer for AUVI-Q. Additional training resources are available at www.auvi-q.com.

    • Practice with the Trainer for AUVI-Q before an allergic emergency happens to familiarize yourself with the use of AUVI-Q in an allergic emergency.
    • The Trainer for AUVI-Q does not contain a needle or medicine and can be reused to practice your injection.
  • If you take too much AUVI-Q, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of AUVI-Q?

AUVI-Q may cause serious side effects.

  • AUVI-Q should only be injected into your outer thigh. Do not inject AUVI-Q 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.

  • 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 at an injection site:

    • redness that does not go away
    • swelling
    • tenderness
    • the area feels warm to the touch
  • 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. Ask your healthcare provider to show you how to properly hold the leg of a young child or infant during an 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
  • 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.

How should I store AUVI-Q?

  • Store AUVI-Q at room temperature between 68° to 77°F (20° to 25°C).
  • Do not freeze. Do not expose to extreme heat or cold. For example, do not store in your vehicle’s glove box.
  • Before using, examine contents in the viewing window. Solution should be clear. If the solution is discolored, cloudy or contains solid particles, replace the autoinjector.
  • 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 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.

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.

For more information and video instructions on the use of AUVI-Q, go to www.auvi-q.com or call 1-877-302-8847.

Instructions for Use

Read this Instructions for Use carefully before you need to use your AUVI-Q. Before you use AUVI-Q, make sure your healthcare provider shows you the right way to use it. If you have any questions, ask your healthcare provider.

If you are administering AUVI-Q to a young child or infant, hold the leg firmly in place and limit movement prior to and while administering an injection. Ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.

Automated Voice Instructions

AUVI-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for any reason, use AUVI-Q as instructed in these Instructions for Use. It will still work during an allergic reaction emergency.

How to use your AUVI-Q

Figure A.

  1. 1. Pull AUVI-Q up from the outer case. See Figure B.

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.

Figure B.

  1. 2. Pull Red safety guard down and off of AUVI-Q. See Figure C.

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 tight. Pull firmly to remove.

Figure C.

  1. 3. Place black end of AUVI-Q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. See Figure D.

Only inject into the middle of the outer thigh. Do not inject into any other part of the body.

If you are administering AUVI-Q to a young child or infant, hold the leg firmly in place while administering an injection See Figure E.

Figure D.

(For AUVI-Q 0.3 mg and AUVI-Q 0.15 mg)

Figure E.

(For AUVI-Q 0.1 mg)

Note: AUVI-Q makes a distinct sound (click and hiss) when you push it firmly against your outer thigh. This is normal and indicates AUVI-Q is working correctly. Do not pull AUVI-Q away from your leg when you hear the click and hiss sound.

The needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. AUVI-Q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete, and to seek medical care if needed. AUVI-Q will beep, and the lights will blink red.

  1. 4. Get medical care for further treatment of the allergic emergency if needed after using AUVI-Q.

Before you receive AUVI-Q, your healthcare provider should talk to you about when to get emergency help.

Replace the outer case and talk to your healthcare provider about the right way to throw away your AUVI-Q.

Ask your healthcare provider for an AUVI-Q prescription refill.

After the use of AUVI-Q:

  • The black base will lock into place.
  • The voice instruction system will say “seek medical care if needed”, say “this AUVI-Q has been used…”, and the lights will blink red.
  • Do not replace the red safety guard.
  • The viewing window will no longer be clear.
  • It is normal for some medicine to remain in your AUVI-Q after you have received your dose of medicine.
  • Talk to your healthcare provider about the right way to throw away your AUVI-Q.
  • AUVI-Q is a single-dose auto-injector and cannot be reused. AUVI-Q must be used or properly disposed after the red safety guard is removed.

Until you throw away your used AUVI-Q, the electronic voice instruction system will remind you that it has been used when the outer case is removed.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration

Revised: Apr 2025

Manufactured for:

kaleo, Inc.

Richmond, VA 23219 USA

This product may be covered by one or more U.S. patents or pending patent applications; see www.kaleo.com for details. KALÉO® and AUVI-Q® are registered trademarks of kaleo, Inc.

© 2025 kaleo, Inc.

*For California Only: This product uses batteries containing Perchlorate Material – special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 201739 · View the label on DailyMed

Revision date stated in the text: April 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Auvi-Q

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Catecholamine, alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Active ingredient Epinephrine
Dosage form Injection, solution
Route Intramuscular
Marketing status listed in the FDA NDC Directory
Company (applicant) KALEO INC
FDA approval NDA 201739New Drug Application (NDA) Approved August 10, 2012
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code BXCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.3 mg/0.3 mL – 0.3 ml in 1 dose pack / 2 in 1 carton NDC 60842-023-02
0.3 mg/0.3 mL – 0.3 ml in 1 dose pack / 2 in 1 carton NDC 60842-023-01
0.15 mg/0.15 mL – 0.15 ml in 1 dose pack / 2 in 1 carton NDC 60842-022-02
0.15 mg/0.15 mL – 0.15 ml in 1 dose pack / 2 in 1 carton NDC 60842-022-01
0.1 mg/0.1 mL – 0.1 ml in 1 dose pack / 2 in 1 carton NDC 60842-021-02
0.1 mg/0.1 mL – 0.1 ml in 1 dose pack / 2 in 1 carton NDC 60842-021-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.