Auvi-Q

Name: Auvi-Q

Clinical pharmacology

Mechanism Of Action

Epinephrine acts on both alpha and beta-adrenergic receptors.

Pharmacodynamics

Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.

Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.

Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

What is epinephrine injection?

Epinephrine is 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.

Epinephrine 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.

Epinephrine auto-injectors may be kept on hand for self-injection by a person with a history of an severe allergic reaction.

Epinephrine injection may also be used for purposes not listed in this medication guide.

How should I use epinephrine injection?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Epinephrine is injected into the muscle 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 epinephrine injection. Do not use a trainer pen to treat an allergic reaction.

The auto-injector device is a disposable single-use system that comes with patient instructions for safe and effective use. Do not inject this medicine if you do not understand these instructions.

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 epinephrine auto-injector:

  • Form a fist around the auto-injector with the tip pointing down. Pull off the safety cap.

  • Place the tip against the fleshy portion of your outer thigh. You may give the injection directly through your clothing.

  • Push the auto-injector firmly against your thigh to release the needle that injects the dose of epinephrine. Hold the auto-injector in place for 10 seconds after activation.

  • Remove the auto-injector from your thigh and massage the area gently. Carefully re-insert the used device needle-first into the carrying tube. Re-cap the tube and take it with you to the emergency room so that anyone who treats you will know how much epinephrine you have received.

  • Use an auto-injector only one time. Do not try to reinsert an auto-injector a second time if the needle has come out of your skin before the full 10 seconds. If the needle is bent from the first use, it may cause serious injury to your skin.

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 epinephrine injection 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.

What other drugs will affect epinephrine injection?

Other drugs may interact with epinephrine injection, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Auvi-Q Dosage and Administration

Selection of the appropriate dosage strength (Auvi-Q 0.3 mg or Auvi-Q 0.15 mg) is determined according to patient body weight.

  • Patients greater than or equal to 30 kg (approximately 66 pounds or more): Auvi-Q 0.3 mg
  • Patients 15 to 30 kg (33 pounds to 66 pounds): Auvi-Q 0.15 mg

Inject Auvi-Q intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed Auvi-Q and who may be uncooperative and kick or move during an injection to hold the child’s leg firmly in place and limit movement prior to and during an injection [see WARNINGS AND PRECAUTIONS (5.2)].

Each Auvi-Q contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from Auvi-Q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional Auvi-Q may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see WARNINGS AND PRECAUTIONS (5.1)].

The epinephrine solution in the viewing window of Auvi-Q should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see STORAGE AND HANDLING (16.2)].

Dosage Forms and Strengths

  • Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector
  • Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector

Auvi-Q - Clinical Pharmacology

MECHANISM OF ACTION

Epinephrine acts on both alpha and beta-adrenergic receptors.

PHARMACODYNAMICS

Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.

Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.

Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

Patient information

Auvi-Q® (epinephrine injection)
Auto-Injector
For allergic emergencies (anaphylaxis)

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).

What should I tell my healthcare provider 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 1 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 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 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.

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 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 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 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 1-844-828-8472.

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.

Instructions for Use

Read these 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, hold the leg firmly in place and limit movement prior to and while administering an injection.

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. Pull Auvi-Q 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.

2. Pull off Red safety guard. 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.

3. Place black end of Auvi-Q against the middle of the outer thigh (through clothing, if needed), then press firmly, and hold in place for 5 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, hold the leg firmly in place while administering an injection.

Note: Auvi-Q makes a distinct sound (click and hiss) when you press it 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 5-second countdown after it is activated, then the voice instruction will indicate the injection is complete, Auvi-Q will beep, and the lights will blink red.

Figure D.

4. Get emergency medical help right away.

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 Auvi-Q has been used and the lights will blink red.
  • The red safety guard cannot be replaced.
  • 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-use injectable device. Once Auvi-Q has been used, any medicine that remains in the auto-injector cannot be reused.

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.

If you will be administering Auvi-Q to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.

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

Rev May 2016

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.kaleopharma.com/pat for details.

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



PRINCIPAL DISPLAY PANEL - NDC 60842-022-01 - 0.15mg 2-plus-1 Carton Label



(web3)