Here are answers to many of the common–and some not so common–questions about Auvi‑Q.
A bioequivalence clinical study was conducted using Auvi‑Q and EpiPen®. Both auto‑injectors delivered 0.3 mg of epinephrine. Injections with epinephrine using Auvi‑Q were well tolerated and resulted in epinephrine plasma concentration levels that were found to be bioequivalent to EpiPen®.1
There are 2 different dosages that have been approved for Auvi‑Q. Selection of the appropriate dosage strength (Auvi‑Q 0.3 mg or Auvi‑Q 0.15 mg) is determined by a healthcare provider, according to patient body weight.
Auvi‑Q 0.3 mg delivers a 0.3‑mg epinephrine injection and is intended for patients who weigh 66 pounds or more.
Auvi‑Q 0.15 mg delivers a 0.15‑mg epinephrine injection and is intended for patients who weigh 33‑66 pounds.2
As many as 10% to 20% of people experiencing anaphylaxis may require more than 1 dose of epinephrine to treat symptoms. In the case of a severe or protracted reaction, guidelines recommend the administration of a dose of epinephrine every 5‑15 minutes until symptoms abate. More than 1 dose of epinephrine may also be needed in cases of biphasic anaphylaxis in which symptoms recur within 1‑72 hours (usually within 8‑10 hours) after the initial symptoms have resolved, despite no further exposure to the trigger. More than 2 doses of epinephrine should be administered only under direct medical supervision. 3,4
Therefore, it is important that at‑risk patients carry 2 EAIs with them at all times. 3,4 Each Auvi‑Q pack contains 2 EAIs as well as a training device.
Auvi‑Q provides a dose of epinephrine through an auto‑injector. Unlike other epinephrine auto‑injector devices on the market, Auvi‑Q is the first and only compact epinephrine auto‑injector with audio and visual cues. These cues guide patients and caregivers through the injection process step by step. View an Auvi‑Q demonstration video.
If the user does not pull off the red safety guard, the device will repeat the instruction until the red safety guard has been removed. After 3 times, the voice prompt will remind the user to replace the case by saying, "If not ready to use, replace the outer case," and the LED light will blink green/red.
Only remove the red safety guard when ready to use the active Auvi‑Q device. The red safety guard should NOT be replaced once it has been removed. Training devices are provided with each Auvi‑Q prescription for practice and preparedness.
The red safety guard ensures sterility of product and protects the needle. When removed, the red safety guard readies the device for use. Removing the red safety guard causes the voice script to permanently advance to the next step, and the user will no longer hear "If you are ready to use, pull off red safety guard, if not ready to use, replace the outer case."
If the user does not depress the black end within a few seconds, the device will repeat the instruction – "To inject, place black end against outer thigh, then press firmly and hold in place for 5 seconds" – until the black end has been pressed. The LED light will blink green.
A bioequivalence clinical study was conducted using Auvi‑Q and EpiPen®. Both auto‑injectors delivered 0.3 mg of epinephrine. Injections with Auvi‑Q resulted in epinephrine plasma concentration levels that were found to be bioequivalent to EpiPen®.1
No, Auvi‑Q is not substitutable by the pharmacy. The patient will need a prescription specifically for Auvi‑Q.
The battery in Auvi‑Q is made to last several years. The battery will significantly outlast the shelf life of epinephrine, the medication used in Auvi‑Q. Patients will need to refill their Auvi‑Q prescription long before the battery loses power. In any case, the actual injection mechanism of Auvi‑Q works independently of its electronic features and does not need a battery to deliver epinephrine.1
Yes, the actual injection mechanism of Auvi‑Q works independently of its electronic features and does not need a battery to deliver epinephrine.1
Auvi‑Q has an expiration date, which is etched on the very top on the back of the device. The safety and efficacy of expired epinephrine has not been evaluated, but the effectiveness of epinephrine may decrease after the expiration date; therefore, patients should promptly refill their Auvi‑Q before the expiration date.1,5
To help ensure timely prescription refills, the Auvi‑Q Refill Reminders program automatically reminds patients when to refill their prescription. Patients can sign up on the Auvi‑Q patient Web site.
Epinephrine is light sensitive. 2,5 Auvi‑Q should be stored in the outer case provided to protect the epinephrine from light.
Patients should store their Auvi‑Q(s) at 20°C‑25°C (68°F‑77°F) and excursions are permitted to 15°C‑30°C (59°F‑86°F). Auvi‑Q should not be refrigerated. Before using, patients should check to make sure the solution in the auto‑injector is clear and colorless. Auvi‑Q should be replaced if the solution is discolored, cloudy, or contains particles. 2
Yes, when patients are prescribed Auvi‑Q, they will receive 2 active devices and a trainer. 2
For more information about traveling abroad, at-risk patients can also check with allergy associations like Food Allergy Research and Education (FARE, formerly FAAN/FAI).
At this time, Auvi‑Q is available in English only.
As directed by the product label, patients/caregivers are instructed to return used or expired Auvi‑Q devices to their healthcare professional for proper disposal and prescription refill. For more information on how to dispose of Auvi‑Q, contact Sanofi customer service at 800‑633‑1610.
EpiPen® is a registered trademark of Mylan Inc. licensed exclusively to its wholly‑owned subsidiary, Dey Pharma, L.P.
Auvi‑Q® (epinephrine injection, USP) is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to allergens, idiopathic and exercise-induced anaphylaxis. Auvi‑Q is intended for individuals with a history of anaphylaxis or who are at risk for anaphylactic reactions.
Auvi‑Q should ONLY be injected into the anterolateral aspect of the thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY.
Epinephrine should be administered with caution to patients with certain heart diseases, and in patients who are on medications that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease or taking cardiac glycosides or diuretics. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
Auvi‑Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical or hospital care.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see full Prescribing Information.
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