May 25, 2016
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"Dec. 24, 2012 -- Colorado Springs high school junior Morgan Smith can't remember a time when he didn't have life-threatening food allergies.

The 16-year-old had his first reaction to peanut butter at 9 months of age when he broke out in hiv"...



How Supplied


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.


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.

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].

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].


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

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

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.

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 Revised: Feb 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/15/2016

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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