alpha-Adrenergic Agonist

Auvi-Q

Approved 10 Aug 2012Intramuscular, SubcutaneousSolution

The FDA lists this product in 3 strengths and forms.

Indications

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. AUVI-Q contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. ( 1 )

Contraindications

None. None. ( 4 )

Warnings and precautions

In conjunction with use, seek immediate medical or hospital care. ( 5.1 ) Do not inject intravenously, into buttock, or into digits, hands, or feet. ( 5.2 ) To minimize the risk of injection-related injury, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection when administering to young children or infants. ( 5.2 ) Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection.

Advise patients to seek medical care if they develop signs or symptoms of infection at the epinephrine injection site. ( 5.3 ) The presence of a sulfite in this product should not deter use. ( 5.4 ) Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ( 5.5 )

Indications

Warnings and precautions

Adverse reactions

Due to lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below. Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties.

These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [ see WARNINGS AND PRECAUTIONS ( 5.5 ) ]. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [ see WARNINGS AND PRECAUTIONS ( 5.5 ) and DRUG INTERACTIONS ( 7 ) ].

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see WARNINGS AND PRECAUTIONS ( 5.5 ) ]. Angina may occur in patients with coronary artery disease [ see WARNINGS AND PRECAUTIONS ( 5.5 ) ]. Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine. Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [ see WARNINGS AND PRECAUTIONS ( 5.2 ) ].

Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury. Injection of epinephrine into the buttock has resulted in cases of gas gangrene [ see WARNINGS AND PRECAUTIONS ( 5.2 ) ]. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection in the thigh [ see WARNINGS AND PRECAUTIONS ( 5.2 ) ].

Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact kaleo, Inc. at 1-844-828-8472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Auvi-Q

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Auvi-Q

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1EMERGENCY TREATMENT

5.2INJECTION-RELATED COMPLICATIONS

5.3SERIOUS INFECTIONS AT THE INJECTION SITE

5.4ALLERGIC REACTIONS ASSOCIATED WITH SULFITE

5.5DISEASE INTERACTIONS

Interactions

Pregnancy and breastfeeding

8.1PREGNANCY Teratogenic Effects: Pregnancy Category C.

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance