Auvi-Q injection contains epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

Auvi-Q injection is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis.

Auvi-Q auto-injectors may be kept on hand for self-injection by a person with a history of an severe allergic reaction. This medicine is for use in adults and children who weigh at least 16.5 pounds (7.5 kilograms).

Seek emergency medical attention after any use of Auvi-Q to treat a severe allergic reaction. After the injection you will need to receive further treatment and observation.

Before using this medicine

Before using Auvi-Q, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

To make sure Auvi-Q is safe for you, tell your doctor if you have ever had:

• heart disease or high blood pressure;

• asthma;

• Parkinson's disease;

• depression or mental illness;

• a thyroid disorder; or

• diabetes.

Having an allergic reaction while pregnant or nursing could harm both mother and baby. You may need to use epinephrine during pregnancy or while you are breastfeeding. Seek emergency medical attention right away after using the injection.

If possible during an emergency, tell your medical caregivers if you are pregnant or breastfeeding.

The Auvi-Q auto-injector device is a disposable single-use system. Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not inject this medicine if you do not understand these instructions. Use the medicine exactly as directed. Ask your doctor or pharmacist if you do not understand these instructions.

Use an auto-injector only one time. Do not try to reinsert an auto-injector a second time. If the needle is bent from the first use, it may cause serious injury to your skin.

Do not give this medicine to a child without medical advice.

Auvi-Q is injected into the skin (subcutaneously) or muscle (intramuscularly) of your outer thigh. In an emergency, this injection can be given through your clothing.

Your medicine may also come with a "trainer pen." The trainer pen contains no medicine and no needle. It is only for non-emergency use to practice giving yourself an Auvi-Q injection.

Do not remove the safety cap until you are ready to use the auto-injector. Never put your fingers over the injector tip when removing the safety cap or after the safety cap has been removed.

To use an Auvi-Q auto-injector:

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 directed in the steps below. It will still work during an allergic reaction emergency.

1. Pull Auvi-Q up from the outer case.

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 that the red safety guard is made to fit tight. Pull firmly to remove.

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. 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.

   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.

4. Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction.

   The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

Do not use Auvi-Q if it has changed colors or has particles in it, or if the expiration date on the label has passed. Call your pharmacist for a new prescription.

Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze this medication, and do not store it in a car.

Do not reuse a needle or syringe. Use only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Before using Auvi-Q, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

To make sure Auvi-Q is safe for you, tell your doctor if you have ever had:

• heart disease or high blood pressure;

• asthma;

• Parkinson's disease;

• depression or mental illness;

• a thyroid disorder; or

• diabetes.

Having an allergic reaction while pregnant or nursing could harm both mother and baby. You may need to use epinephrine during pregnancy or while you are breastfeeding. Seek emergency medical attention right away after using the injection.

If possible during an emergency, tell your medical caregivers if you are pregnant or breastfeeding.

Since epinephrine is used when needed, it does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include numbness or weakness, severe headache, blurred vision, pounding in your neck or ears, sweating, chills, chest pain, fast or slow heartbeats, severe shortness of breath, or cough with foamy mucus.

Do not inject epinephrine into a vein or into the muscles of your buttocks, or it may not work as well. Inject it only into the fleshy outer portion of the thigh.

Accidentally injecting epinephrine into your hands or feet may result in a loss of blood flow to those areas, and resulting numbness.

Before using epinephrine, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

Call your doctor at once if you notice pain, swelling, warmth, redness, or other signs of infection around the area where you gave an injection.

Side effects may be more likely in older adults.

Common Auvi-Q side effects may include:

• breathing problems;

• fast, irregular, or pounding heartbeats;

• pale skin, sweating;

• nausea and vomiting;

• dizziness;

• weakness or tremors;

• headache; or

• feeling restless, fearful, nervous, anxious, or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• asthma medicine;

• an antidepressant;

• cold or allergy medicine (Benadryl and others);

• heart or blood pressure medicine;

• thyroid medication; or

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine.

This list is not complete. Other drugs may interact with epinephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.