WASHINGTON -- The FDA has approved the first voice-guided epinephrine injection device (Auvi-Q) for treatment of severe allergic reactions. The device, which gives verbal step-by-step instructions, can be used by children weighing at least 33 pounds who are at risk for, or have a history of, anaphylaxis.
Developed by Sanofi US, the Auvi-Q 0.15 mg/0.3 mg auto-injector comes in a rectangular box that is roughly the size of a credit card, and guides a user through the injection process with audio-visual instructions as well as or written directions. Most epinephrine auto-injectors are in a wand-like form. A video demonstration of the device on the manufacturer's website shows a young user removing the device's outer case, which triggers an audio cue -- two beeps, followed by the instructions, "If you are ready to use, pull off the red safety guard." The user removes the safety guard and the device then says, "To inject, place black end against outer thigh, then press firmly and hold in place for 5 seconds."
Once the device is firmly pressed, a loud click signals the injection has begun and the device audibly counts down for 5 seconds, alerts the user that the injection is complete, and that the patient should seek emergency medical attention and refill the prescription. A written guide with the same instructions is printed on the side of the box and an "alert light" goes off once an injection is completed. The device contains a retractable needle mechanism that prevents accidental needle sticks after use. The injector will be available in two dosages, with a 0.15 mg dose indicated for patients weighing 33 to 66 pounds. and a 0.3 mg dose indicated for patients weighing more than 66 pounds. The device has not been studied in patients weighing less than 33 pounds. It will be packaged with two epinephrine-containing injectors and an inactive training injector. Each injector contains a single dose of epinephrine. The drug injection system was shown to be bioequivalent in a clinical trial comparing the device with the EpiPen auto-injector.
The device should only be used on the outer thigh. Patients who inject other parts of their body should seek emergency medical attention.Patients taking other medications may be at risk of developing serious adverse events with administration of epinephrine, including increased heart rate, irregular heartbeat, sweating, nausea, vomiting, difficulty breathing, paleness, dizziness, weakness, headache, apprehension, and anxiety.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments:"It will be good to have another option of epinephine autoinjector available to our patients. The smaller size will be better for people who need to carry the device in their pocket, and the voice instructions should reduce mistakes with administration."
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