Is Your Patient at Risk?

In addition to prior reaction history and known specific triggers,  a variety of other factors may put your patient at increased risk of anaphylaxis severity and fatality. Many of these factors will also affect your decision for prescribing epinephrine auto-injector. The following is a partial list of some of these factors.

In addition to prior reaction history and known specific triggers, a variety of other factors may put your patient at increased risk of anaphylaxis severity and fatality. Many of these factors will also affect your decision for prescribing epinephrine auto-injector. The following is a partial list of some of these factors.

Factors that may increase the risk of anaphylaxis severity and fatality

Age
  • Adolescents and young adults: Increased risk-taking behavior and inconsistent behaviors regarding avoiding relevant triggers and carrying epinephrine auto-injectors8
  • Elderly: Concomitant diseases, such as chronic obstructive pulmonary disease (COPD) and cardiovascular diseases (CVDs), and the medications used to treat them, as well as increased risk of fatality from venom-triggered anaphylaxis8
Comorbid conditions
  • Asthma and other respiratory diseases, especially if severe or uncontrolled8
  • CVDs, including hypertension8
  • Mastocytosis and clonal mast cell disorders suggested by an increase in baseline total tryptase levels8
  • Allergic rhinitis and eczema (Atopic diseases are a risk factor for anaphylaxis triggered by food, exercise, and latex; however, atopic diseases are not a risk factor for anaphylaxis triggered by insect stings, β-lactam antibiotics, or insulin.) 8
  • Depression and other psychiatric diseases that might impair recognition of symptoms8
  • Thyroid disease (some patients with idiopathic anaphylaxis8
Concurrent medication and/or chemical use
  • Sedatives/hypnotics/antidepressants/ethanol/recreational drugs (potentially affect recognition of anaphylaxis) 8
  • β-blockers and ACE inhibitors (potentially increase anaphylaxis severity) 8
Other factors
  • Exercise8
  • Acute infection (such as upper respiratory tract infection) 8
  • Menses8
  • Emotional stress8
  • Occupation (such as landscaping)
  • Priming effect of recent previous anaphylactic episode8
  • Increased baseline plasma histamine levels (hyperhistaminemia8
  • Increased baseline serum tryptase levels8
  • Reduced level of PAF AH activity, leading to increased PAF levels8
  • Reduced level of ACE activity, leading to increased bradykinin levels8

Factors that may influence your decision to prescribe epinephrine auto-injector

Reaction history
  • Previous anaphylactic reaction14
  • Reaction to trace allergen exposure14
  • Repeat exposures likely14
  • Specific triggers associated with severe reaction (e.g., insect venom, peanut, tree nut, seafood) 14
  • Idiopathic anaphylaxis14
Diseases or conditions that may interfere with prompt recognition of symptom severity
  • Impaired vision or hearing8
  • Neurologic disorders8
  • Autism spectrum disorder8
  • Developmental delay8
Persons in whom it is difficult for a caregiver to recognize anaphylaxis symptoms
  • Those supervised by a caregiver without healthcare training or experience14
  • Those within a dysfunctional family14
  • Those with skin disease such as eczema or color that makes it difficult to detect erythema14
  • Those unable to recognize or describe their symptoms adequately (such as children, infants, those with learning disabilities or language barriers) 14
Anyone with barriers to prompt treatment by professionals
  • Living alone14
  • Living in a remote area14
  • Lacking reliable transportation14
  • Lacking telephone service14

Indications and Usage

The epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Warnings and Precautions

Emergency Treatment: The epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

Incorrect Locations of Injection: The epinephrine injection, USP auto-injector should ONLY be injected into the anterolateral aspect of the thigh. Do not inject intravenously. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration. Do not inject into buttock. Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Injection into the buttock has been associated with the development of Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the risk. Do not inject into fingers, hands or feet. Since epinephrine is a strong vasoconstrictor, accidental injection into the fingers, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis. Hold leg firmly during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering epinephrine injection, USP auto-injector to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

Allergic Reactions Associated with Sulfite: The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.

Serious Infections at the Injection Site: 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 for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection.

Disease Interactions: Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Patients with Heart Disease. Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. Other Patients and Diseases. Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.

Adverse Reactions

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.

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease.

Accidental injection into the fingers, hands or feet may result in loss of blood flow to the affected area.

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.

Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection. Injection into the buttock has resulted in cases of gas gangrene.

Rare cases of serious skin and soft tissue infections caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh.

Use in Specific Populations

Elderly patients may be at greater risk of developing adverse reactions.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088."

For full prescribing information and video instructions on the use of the epinephrine injection, USP auto-injector, go to www.epinephrineautoinject.com or call 1-888-894-6528.












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