Auvi-Q™ for Type 1 Allergic Reactions and Anaphylaxis

San Diego—As many as 6 million people in the United States are at risk of anaphylaxis, and the prevalence is increasing, especially among people <20 years of age, according to several studies. In August 2012, the FDA approved Auvi-Q^™ (epinephrine injection, USP) as an emergency treatment for type 1 allergic reactions, including anaphylaxis, to stinging and biting insects.

Todd Mahr, MD, director of pediatric allergy and immunology at the Gundersen Lutheran Medical Center in La Crosse, Wisconsin, provided an overview of the drug during a Product Theater at the AMCP meeting. Sanofi, the product’s manufacturer, sponsored the session.

Patients at an increased risk for anaphylaxis, including those with a history of anaphylactic reactions, are advised to take an epinephrine injection in emergency circumstances. Patients should not use epinephrine injection as a substitute for immediate medical care. They are advised to inject it and then seek medical care. The injection is only intended for the anterolateral aspect of the thigh. Patients are advised not to take the injection intravenously, in the buttocks, or in their hands or feet.

This product includes voice instructions that help guide the users through each step of the injection process. It also comes with a retractable needle mechanism to help prevent accidental needle sticks. There are 2 dosage strengths: (1) 0.3 mg for patients who weigh ≥30 kg and (2) 0.15 mg for patients who weigh from 15 kg to 30 kg.

Dr. Mahr discussed guidelines from the World Allergy Organization noting that anaphylaxis is highly likely when a person fulfills any of the following 3 criteria: (1) a sudden onset of an illness with involvement of the skin, mucosal tissue, or both plus respiratory compromise or reduced blood pressure or symptoms of end-organ dysfunction; (2) ≥2 of the following occurring within minutes or several hours after exposure: skin or mucosal symptoms/signs, respiratory compromise, reduced blood pressure or associated symptoms, or persistent gastrointestinal symptoms; or (3) reduced blood pressure within minutes or several hours after exposure to a known allergen.

According to Dr. Mahr, epinephrine is the first-line treatment for anaphylaxis, although he said epinephrine is underutilized. All other drugs have a delayed onset of action. He added that antihistamines are considered second-line treatment and should not be substituted for epinephrine.

Patients at risk for anaphylaxis are told to carry epinephrine auto-injectors in case of a biphasic reaction, but 2 large surveys that Dr. Mahr cited found up to 71% of at-risk patients and caregivers do not always carry them. After injecting epinephrine, patients must seek medical attention, according to Dr. Mahr.

Adverse reactions associated with epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, nausea, and vomiting. According to the product’s Prescribing Information, the symptoms usually subside quickly, although patients with hypertension, hyperthyroidism, or coronary artery disease could develop serious adverse effects.

The Prescribing Information for epinephrine injection indicates that the product should be administered with caution in patients with certain heart diseases and patients on medications that may lead to arrhythmias. It noted that patients with cardiac disease or who are taking cardiac glycosides or diuretics have had arrhythmias, including fatal ventricular fibrillation. In addition, patients taking certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension may be at a greater risk of adverse events.