AUVI-Q- epinephrine injection 
sanofi-aventis U.S. LLC

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Auvi‑Q® safely and effectively. See full prescribing information for Auvi‑Q®.
Auvi‑Q® (epinephrine injection, USP) 0.3 mg, 0.15 mg Auto-Injector
Initial U.S. Approval: 2012

INDICATIONS AND USAGE

Auvi‑Q® contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. (1)

DOSAGE AND ADMINISTRATION

  • Patients greater than or equal to 30 kg (66 lbs): Auvi‑Q® 0.3 mg (2)
  • Patients 15 to 30 kg (33 lbs – 66 lbs): Auvi‑Q® 0.15 mg (2)

Inject Auvi‑Q® intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-use injection. (2)

DOSAGE FORMS AND STRENGTHS

  • Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (3)
  • Injection, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector (3)

CONTRAINDICATIONS

None (4)

WARNINGS AND PRECAUTIONS

  • In conjunction with use, seek immediate medical or hospital care. (5.1)
  • Do not inject intravenously, into buttock, or into digits, hands, or feet. (5.2)
  • The presence of a sulfite in this product should not deter use. (5.3)
  • Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. (5.4)

ADVERSE REACTIONS

Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. (6)


To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Cardiac glycosides or diuretics: observe for development of cardiac arrhythmias. (7)
  • Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines: potentiate effects of epinephrine. (7)
  • Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of epinephrine. (7)
  • Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of epinephrine. (7)
  • Ergot alkaloids: may reverse the pressor effects of epinephrine. (7)

USE IN SPECIFIC POPULATIONS

  • Elderly patients may be at greater risk of developing adverse reactions. (5.4, 8.5)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2014

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Emergency Treatment

5.2 Incorrect Locations of Injection

5.3 Allergic Reactions Associated with Sulfite

5.4 Disease Interactions

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

17.1 Administration and Training

17.2 Adverse Reactions

17.3 Accidental injection

17.4 Storage and Handling

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Auvi‑Q® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Auvi‑Q® is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

Auvi‑Q® is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care.

2 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.

Inject Auvi‑Q® intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.

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)].

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Emergency Treatment

Auvi‑Q® is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see INDICATIONS AND USAGE (1), DOSAGE AND ADMINISTRATION (2) and PATIENT COUNSELING INFORMATION (17.1)].

5.2 Incorrect Locations of Injection

Auvi‑Q® should ONLY be injected into the anterolateral aspect of the thigh [see DOSAGE AND ADMINISTRATION (2) and PATIENT COUNSELING INFORMATION (17.1)].

  • Do not inject intravenously. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.
  • Do not inject into buttock. Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis.
  • Do not inject into digits, hands or feet. Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see ADVERSE REACTIONS (6)].

5.3 Allergic Reactions Associated with Sulfite

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.

The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.

The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.

5.4 Disease Interactions

Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer Auvi‑Q® to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.

  • Patients with Heart Disease
    Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see DRUG INTERACTIONS (7) and ADVERSE REACTIONS (6)].
  • Other Patients and Diseases
    Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson's disease may notice a temporary worsening of symptoms.

6 ADVERSE REACTIONS

Adverse reactions to epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see WARNINGS AND PRECAUTIONS (5.4)].

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see WARNINGS AND PRECAUTIONS (5.4) and DRUG INTERACTIONS (7)].

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see WARNINGS AND PRECAUTIONS (5.4)].

Angina may occur in patients with coronary artery disease [see WARNINGS AND PRECAUTIONS (5.4)].

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS AND PRECAUTIONS (5.2)].

Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

7 DRUG INTERACTIONS

Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see WARNINGS AND PRECAUTIONS (5.4)].

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol.

The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine.

Ergot alkaloids may also reverse the pressor effects of epinephrine.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women.

Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).

Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).

These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).

8.3 Nursing Mothers

It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Auvi‑Q® is administered to a nursing woman.

8.4 Pediatric Use

Auvi‑Q® may be given safely to pediatric patients at a dosage appropriate to body weight [see DOSAGE AND ADMINISTRATION (2)]. However, studies in pediatric patients weighing less than 15 kg (33 pounds) have not been conducted.

8.5 Geriatric Use

Clinical studies of Auvi‑Q® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Epinephrine should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see WARNINGS AND PRECAUTIONS (5.4), OVERDOSAGE (10)].

10 OVERDOSAGE

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

11 DESCRIPTION

Auvi‑Q® (epinephrine injection, USP) 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.

Auvi‑Q® includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use.

Each Auvi‑Q® 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution.

Each Auvi‑Q® 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution.

Auvi‑Q® 0.3 mg and Auvi‑Q® 0.15 mg each contain 0.76 mL epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution is dispensed for Auvi‑Q® 0.3 mg and Auvi‑Q® 0.15 mg, respectively, when activated. The remaining solution is not available for future use and should be discarded.

Each 0.3 mL in Auvi‑Q® 0.3 mg contains 0.3 mg epinephrine, 2.3 mg sodium chloride, 0.5 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0.

Each 0.15 mL in Auvi‑Q® 0.15 mg contains 0.15 mg epinephrine, 1.2 mg sodium chloride, 0.2 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0.

Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:

Structural formula of Epinephrine

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.

Auvi‑Q® is not made with natural rubber latex.

Auvi‑Q® instructional and safety systems should be thoroughly reviewed with patients and caregivers prior to use [see PATIENT COUNSELING INFORMATION (17.1)].

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Epinephrine acts on both alpha and beta-adrenergic receptors.

12.2 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.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.

Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay.

Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.

The potential for epinephrine to impair fertility has not been evaluated.

This should not prevent the use of epinephrine under the conditions noted under INDICATIONS AND USAGE (1).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Carton containing two Auvi‑Q® (epinephrine injection, USP) 0.3 mg auto-injectors and a single Auvi‑Q® Trainer - NDC 0024-5833-02

Carton containing two Auvi‑Q® (epinephrine injection, USP) 0.15 mg auto-injectors and a single Auvi‑Q® Trainer - NDC 0024-5831-02

Rx only

16.2 Storage and Handling

Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored, cloudy, or contains particles.

17 PATIENT COUNSELING INFORMATION

[see FDA-Approved Patient Labeling]
A healthcare provider should review the patient instructions and operation of Auvi‑Q®, in detail, with the patient or caregiver.

Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used.

17.1 Administration and Training

Patients and/or caregivers should be instructed in the appropriate use of Auvi‑Q®. Auvi‑Q® should be injected into the middle of the outer thigh (through clothing, if necessary). Each device is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of Auvi‑Q®.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each Auvi‑Q® carton. A printed label on the surface of Auvi‑Q® shows instructions for use and a diagram depicting the injection process. Auvi‑Q® also emits visual prompts and electronic voice instructions for use.

Patients and/or caregivers should be instructed to use the Trainer to familiarize themselves with the use of Auvi‑Q® in an allergic emergency. The Trainer may be used multiple times.

17.2 Adverse Reactions

Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms [see WARNINGS AND PRECAUTIONS (5.4)].

17.3 Accidental injection

Patients should be advised to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment should be directed at vasodilatation if there is such an accidental injection to these areas [see WARNINGS AND PRECAUTIONS (5.2)].

17.4 Storage and Handling

Patients should be instructed to inspect the epinephrine solution visually through the viewing window periodically. Auvi‑Q® should be replaced if the epinephrine solution appears discolored (pinkish color or darker than slightly yellow), cloudy, or contains particles. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light. Patients should be instructed that Auvi‑Q® must be used or properly disposed once the red safety guard is removed [see STORAGE AND HANDLING (16.2)].

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each Auvi‑Q® carton.

INSTRUCTIONS for Use

How to use Auvi‑Q®

1. Pull Auvi‑Q® from the outer case
Do not proceed to step 2 until you are ready to use Auvi‑Q®. If not ready to use, replace the outer case.

Pull Auvi‑Q® from the outer case

2. Pull off Red safety guard
To avoid an accidental injection, never touch the black base of the auto-injector. If an accidental injection does occur, seek medical help immediately.
NOTE: The safety guard is meant to be tight. Pull firmly to remove.

Pull off Red safety guard

3. Place black end against the middle of the outer thigh (through clothing, if necessary), then press firmly and hold in place for 5 seconds. Each device is a single-use injection.

Only inject into the middle of the outer thigh (upper leg). Do not inject into any other location. Note: Auvi‑Q® makes a distinct sound (click and hiss) when activated. 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.

Place black end against the middle of the outer thigh (through clothing, if necessary) and hold in place for 5 seconds

4. Seek medical attention immediately
Replace the outer case and take your used Auvi‑Q® with you to a healthcare professional for proper disposal and a prescription refill.

AFTER using Auvi‑Q®

Seek medical attention immediately.

With a severe, long-lasting allergic reaction, you may need to administer an additional Auvi‑Q®. More than two sequential doses of epinephrine should only be administered under direct medical supervision.
Following administration of Auvi‑Q®:

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The black base will lock into place.
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The voice instruction system will confirm Auvi‑Q® has been used and the LED lights will blink red.
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The red safety guard cannot be replaced.
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The viewing window will no longer be clear.
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Some medicine will remain in Auvi‑Q®. However, the injection is complete and you have received the correct dose of the medication.
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Take to your healthcare provider for proper disposal (never discard Auvi‑Q® in regular trash).*
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Discuss your medical history and current medications with the healthcare professional (for example, diabetic patients may need to adjust the dose of their diabetes medicines or insulin after using Auvi‑Q®).

Auvi‑Q® and any remaining medicine cannot be reused. Until you dispose of your used Auvi‑Q®, the interactive instruction system will remind you that it has been used whenever you remove the outer case.

General information about the safe and effective use of Auvi‑Q®

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Auvi‑Q® for a condition for which it was not prescribed.
Never give Auvi‑Q® to other people, even if they have the same symptoms you have.
This leaflet summarizes the most important information about Auvi‑Q®. If you would like more information, talk with your Healthcare Provider or Pharmacist.

Revised February 2014
Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

A SANOFI COMPANY

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

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:

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®?

What are the possible side effects of Auvi‑Q®?

Auvi‑Q® may cause serious side effects.

Common side effects of Auvi‑Q® include:

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®?

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.

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.

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

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.

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.

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.

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.

Figure D.

Figure D

4. After using Auvi‑Q®, 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®:

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

Rev February/2014

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

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

Auvi‑Q® TRAINER

Trainer Instructions for Use

Important:
The Auvi-Q® Trainer Does Not contain a needle or medicine. Always carry your real Auvi‑Q® with you in case of an allergic emergency.

Important Information about the Auvi‑Q® Trainer:

Inside your Auvi‑Q® Trainer are:

The Auvi‑Q® Trainer batteries are made to last long enough for you to practice 1 time each day for 2 years. If your Auvi‑Q® Trainer does not work properly call your healthcare provider for a new Trainer.

What is the Auvi‑Q® Trainer?
  • The Auvi‑Q® Trainer does not contain a needle or medicine and can be reused to practice your injection.
  • 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.
Your Auvi‑Q® TrainerFigure A.
Auvi‑Q® TrainerAuvi‑Q®
Figure A. Auvi‑Q® TrainerFigure A. Auvi‑Q®
The Auvi‑Q® Trainer:
  • is inside a gray outer case
  • does not have a needle or medicine inside
  • can be reused (the red safety guard can be placed back on the base of the Trainer after use)
  • has no expiration date
Auvi‑Q®:
  • is inside an orange (0.3 mg) or blue (0.15 mg) outer case
  • contains a needle and epinephrine medicine
  • cannot be reused (the red safety guard cannot be placed back on the base of Auvi‑Q® after use)
  • has a medicine expiration date listed on the device
In case of an allergic emergency, use the real Auvi‑Q® and not the gray Trainer.
Who should practice using the Auvi‑Q® Trainer?Anyone who may need to help you with Auvi‑Q® in case of an allergic emergency:
  • You
  • Caregivers
  • Family
  • Friends
  • Co-workers
  • Teachers
  • Child Care or Day Care Workers
Have them practice using the Trainer and review the Patient Information Leaflet included in the packaging with each prescription of Auvi‑Q®.
For more information and video instructions on the use of Auvi‑Q®, go to www.auvi-q.com or call 1-800-633-1610.
Practicing with the Auvi‑Q® TrainerPractice 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.
  • You should practice daily for the first week after you receive your Auvi‑Q® Trainer to help you feel comfortable using Auvi‑Q® quickly and safely. Even when you are comfortable using the Trainer, continue to practice using it often.
How to Use the Trainer
How the Auvi‑Q® Trainer worksAlthough the Trainer does not have a needle and contains no medicine, it works the same way as the real Auvi‑Q®.
As with the real Auvi‑Q®, the Auvi‑Q® Trainer contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for the Auvi‑Q® Trainer for any reason, you can still use the Auvi‑Q® Trainer as instructed in this leaflet to practice.
The Auvi‑Q® Trainer has the same blinking red and green lights as the real Auvi‑Q®.
Follow These Steps
1.
Pull the Auvi‑Q® Trainer from the outer case.
1. Pull the Auvi‑Q® Trainer from the outer case
2.
Pull off Red safety guard.
2. Pull off Red safety guard
Note: The red safety guard is made to fit tight similar to the safety guard on the real Auvi‑Q®. Pull firmly to remove.
3.
Place black end against the middle of the outer thigh (through clothing, if needed), then press firmly, and hold in place for 5 seconds.
3. Place black end against the middle of the outer thigh (through clothing, if needed), then press firmly, and hold in place for 5 seconds
Only practice using the middle of your outer thigh. The outer thigh is where you would inject with the real Auvi‑Q®.
Note: The Auvi‑Q® Trainer makes a distinct sound (click and hiss) when you press it against your outer thigh. This is the same sound that is made with the real Auvi‑Q®. 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.
4.
After practicing, reset the Auvi‑Q® Trainer:
a.
Replace the Red safety guard
b.
Slide the Auvi‑Q® Trainer all the way back into the gray outer case to reset the electronic voice system
4. After practicing, reset the Auvi‑Q® Trainer
Note: Leave the Auvi‑Q® Trainer in its outer case for at least 5 seconds between each time you practice to allow the electronic voice system to reset.

Storage:

Disposal:
The Auvi‑Q® Trainer contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. Follow your State and local environmental regulations for disposal.

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

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

Rev 2/2014

Principal Display Panel - 0.3 mg Carton

NDC 0024-5833-02
Rx Only

FOR ALLERGIC EMERGENCIES
in patients weighing over 66 lb

PUSH HERE
& LIFT

Auvi-Q®
epinephrine injection, USP
0.3 mg
auto-injector

2
PREFILLED
AUTO-INJECTORS
+
1
TRAINER

SANOFI

Principal Display Panel - 0.3 mg Carton

Principal Display Panel - 0.3 mg Physician Sample Carton

NDC 0024-5833-00
Rx Only

PHYSICIAN SAMPLE. NOT FOR SALE.

FOR ALLERGIC EMERGENCIES
in patients weighing over 66 lb

PUSH HERE
& LIFT

Auvi-Q®
epinephrine injection, USP
0.3 mg
auto-injector

1
PREFILLED
AUTO-INJECTOR
+
1
TRAINER

SANOFI

Principal Display Panel - 0.3 mg Physician Sample Carton

Principal Display Panel - 0.15 mg Carton

NDC 0024-5831-02
Rx Only

FOR ALLERGIC EMERGENCIES
in patients weighing 33 lb–66 lb

PUSH HERE
& LIFT

Auvi-Q®
epinephrine injection, USP
0.15 mg
auto-injector

2
PREFILLED
AUTO-INJECTORS
+
1
TRAINER

SANOFI

Principal Display Panel - 0.15 mg Carton

Principal Display Panel - 0.15 mg Physician Sample Carton

NDC 0024-5831-00
Rx Only

PHYSICIAN SAMPLE. NOT FOR SALE.

FOR ALLERGIC EMERGENCIES
in patients weighing 33 lb–66 lb

PUSH HERE
& LIFT

Auvi-Q®
epinephrine injection, USP
0.15 mg
auto-injector

1
PREFILLED
AUTO-INJECTOR
+
1
TRAINER

SANOFI

Principal Display Panel - 0.15 mg Physician Sample Carton

Principal Display Panel - Trainer Carton

0024-5835-00

PUSH HERE
& LIFT

TRAINER
FOR
Auvi-Q®

CONTAINS NO ACTIVE DRUG OR NEEDLE

SANOFI

Principal Display Panel - Trainer Carton
AUVI-Q 
epinephrine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0024-5833
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE0.3 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE2.3 mg
SODIUM BISULFITE0.5 mg
WATER 
HYDROCHLORIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0024-5833-022 in 1 CARTON
2NDC:0024-5833-001 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20173911/15/2012
AUVI-Q 
epinephrine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0024-5831
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE.15 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE1.2 mg
SODIUM BISULFITE.2 mg
WATER 
HYDROCHLORIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0024-5831-022 in 1 CARTON
2NDC:0024-5831-001 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20173911/15/2012
Labeler - sanofi-aventis U.S. LLC (824676584)
Establishment
NameAddressID/FEIBusiness Operations
Medivative Technologies, LLC131644234ANALYSIS(0024-5833, 0024-5831), LABEL(0024-5833, 0024-5831), PACK(0024-5833, 0024-5831)
Establishment
NameAddressID/FEIBusiness Operations
Alliance Medical Products, Inc.102688657MANUFACTURE(0024-5833, 0024-5831), ANALYSIS(0024-5833, 0024-5831)

Revised: 2/2014
Document Id: 8b98cc58-c32d-4255-b9c9-8ad2ebd7c5ae
Set id: 4c550991-c4cf-11df-851a-0800200c9a66
Version: 9
Effective Time: 20140214
 
sanofi-aventis U.S. LLC