Indication

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 patients with a history of anaphylactic reactions or who are at increased risk for anaphylaxis.

Important Safety Information

AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Each AUVI-Q contains a single dose of epinephrine for single-use injection. More than two sequential doses of epinephrine should only be administered under direct medical supervision. Since the doses of epinephrine delivered from AUVI-Q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary.

AUVI-Q should ONLY be injected into the anterolateral aspect of the thigh. Do not inject intravenously, or into buttock, digits, hands, or feet. Instruct caregivers to hold the leg of young children and infants firmly in place and limit movement prior to and during injection to minimize the risk of injection-related injury.

Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

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. Common adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.

Please see the full Prescribing Information and Patient Information at www.auvi-q.com.

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.