Auvi-Q

Auvi-Q is a compact, voice-guided epinephrine auto-injector for the emergency treatment of anaphylaxis and other severe allergic reactions in adults and children who weigh 16.5 pounds (7.5 kilograms) or more who are at risk of serious allergic reactions. It can be administered intramuscularly (into the muscle) or subcutaneously (under the skin) into the outer thigh, through clothing if necessary.

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, follow the Instructions for Use. Auvi-Q will still work even if the voice guidance fails.

Auvi-Q gained FDA approval on August 10, 2012. There is no generic. However, other non-voice guided epinephrine auto-injectors are available in both generic and branded forms. Epinephrine injections have been approved since 1951.

• 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.
• 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.
• 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.

Read the Instructions for Use for information about the right way to use Auvi-Q.

Use Auvi-Q exactly as your healthcare provider 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 can request a free Trainer from the Auvi-Q website to help you feel more confident using 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.

Notes About Using Your Auvi-Q

• Inject into the middle of your outer thigh, through clothing if needed. Each device is for single-use only.
• After using Auvi-Q, go to an emergency clinic immediately for monitoring and any further treatment needed.
• Check the viewing window periodically. If the solution looks discolored, cloudy, or contains particles, replace your device.
• If injecting a young child or infant, hold their leg firmly in place and limit movement before and during the injection.
• The needle will not be visible after injection, and you may not feel it when it occurs.
• After activation, there is a 2-second countdown before injection. Once complete, the voice prompt will confirm the injection is done. The black base will lock onto the device housing, and the lights will blink red. These are your confirmations that epinephrine has been delivered.
• Practice with the included Trainer device so you feel confident using Auvi-Q in an emergency. The Trainer can be used multiple times.

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 a 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.

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

Auvi-Q contains epinephrine, which works on alpha and beta-adrenergic receptors to rapidly counter anaphylaxis. It constricts blood vessels to restore blood pressure, relaxes airway muscles to relieve bronchospasm and breathing difficulty, and reduces vascular leakage to prevent dangerous fluid loss. It also eases hives, itching, swelling, and gastrointestinal symptoms by relaxing smooth muscle throughout the body.

Auvi-Q (epinephrine injection) belongs to the drug class called non-selective alpha and beta-adrenergic receptor agonists.

The cost for prescription drugs varies depending on your insurance plan and which pharmacy you use. Auvi-Q's retail price can exceed $820 for a 2-pack without insurance, but most patients pay far less. Commercially insured patients typically pay $35 or less, while those without coverage pay no more than $199 through Kaléo's savings program.

The Kaléo patient assistance program is also available for uninsured patients experiencing financial hardship, providing Auvi-Q at no cost. Discount cards can reduce the price further.

Refer to our Drugs.com price guide page for more information about Auvi-Q Prices, Coupons, Copay Cards & Patient Assistance.

Common Side Effects

The most common side effects of Auvi-Q are:

• fast, irregular, or ‘pounding’ heartbeat
• sweating
• shakiness
• headache
• paleness
• feelings of over excitement, nervousness, or anxiety
• weakness
• dizziness
• nausea and vomiting
• breathing problems.

Serious Side Effects

Auvi-Q may cause the following serious side effects:

• Incorrect Injection Site. 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.

• Infections at the injection site. 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.
• Potential Injuries in Young Children. 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.
• Interactions. 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.

Tell your healthcare provider if you have any side effect that bothers you or that do 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 the FDA at 1-800-FDA-1088.

Recommended Dose of Auvi-Q for Severe Allergies, Including Anaphylaxis

• Weight ≥30 kg: Auvi-Q 0.3 mg subcutaneously or intramuscularly
• 15 kg to <30 kg: Auvi-Q 0.15 mg subcutaneously or intramuscularly
• 7.5 kg to <15 kg: Auvi-Q 0.1 mg subcutaneously or intramuscularly

Notes: If symptoms worsen or there is no improvement after the first treatment, a second dose of Auvi-Q may be administered with a second autoinjector starting 5 minutes after the first dose.

After using Auvi-Q, go to an emergency clinic immediately for monitoring and any further treatment needed.

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.

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.

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. Especially tell your healthcare provider if you take:

• Cardiac glycosides, diuretics, or anti-arrhythmics may increase the risk of cardiac arrhythmias when used with epinephrine (examples include digoxin, furosemide, and amiodarone).
• Tricyclic antidepressants, MAOIs, levothyroxine, certain antihistamines, and COMT inhibitors can potentiate the effects of epinephrine (examples include amitriptyline, phenelzine, diphenhydramine, entacapone)
• Beta-blockers (examples include metoprolol, propranolol) may block the heart-stimulating and airway-opening effects of epinephrine
• Alpha-blockers (examples include prazosin, tamsulosin) may reduce the blood vessel-constricting and blood pressure-raising effects of epinephrine
• Ergot alkaloids (examples include ergotamine, methylergonovine) may reverse the blood pressure-elevating effects of epinephrine.

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

Store Auvi-Q at room temperature between 68°F and 77°F (20° and 25°C).

Do not freeze. Do not expose to extreme heat or cold. For example, do not store it in your vehicle’s glove box.

Before using, examine the contents in the viewing window. The 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 all medicines out of the reach of children and pets.

Active ingredient: epinephrine.

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

Available as:

• 0.3 mg (0.3 mg/0.3 mL) epinephrine in a single-dose prefilled autoinjector
• 0.15mg (0.15 mg/0.15 mL) epinephrine in a single-dose prefilled autoinjector
• 0.1 mg (0.1 mg/0.1 mL) epinephrine in a single-dose prefilled autoinjector

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.

Auvi-Q is manufactured by Kaleo, Inc., 111 Virginia Street, Suite 300, Richmond, VA 23219.