Epinephrine auto-injectors are used for the emergency treatment of potentially life-threatening anaphylactic reactions, and each has a unique design and operating instructions for use under stressful conditions.1 It is critical that epinephrine be administered quickly and correctly, without the added confusion of patient or caregiver unfamiliarity with the auto-injector device.2
The Food and Drug Administration (FDA) has rated all epinephrine auto-injectors with an Orange Book rating of “BX,” indicating that insufficient evidence exists to determine therapeutic equivalence. This rating thereby presumes that other epinephrine auto-injector products are not therapeutically equivalent to EpiPen® (epinephrine) Auto-Injector.3 Products that the FDA has determined to be therapeutically equivalent are given an "A" rating.3 If the bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence, the drugs are designated an “AB” rating.3 To date, there are no “AB” rated epinephrine auto-injector devices.3 Therefore, when presented with a prescription for an EpiPen Auto-Injector, it may be unsafe and or violative of state law under certain circumstances for a pharmacist to dispense a different type of epinephrine auto-injector unless it is an A-rated generic, even if the prescriber indicates that substitution is permitted. There are no A-rated generic EpiPen Auto-Injectors for substitution.3
To view the FDA’s Orange Book, please click here.
EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are indicated in the emergency treatment of type 1 allergic reactions, including anaphylaxis, to allergens, idiopathic and exercise-induced anaphylaxis, and in patients with a history or increased risk of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to body weight.
EpiPen Auto-Injectors should only be injected into the anterolateral aspect of the thigh. DO NOT INJECT INTO BUTTOCK, OR INTRAVENOUSLY.
Epinephrine should be used with caution in patients with certain heart diseases, and in patients who are on drugs 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. Other adverse reactions include transient moderate anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
EpiPen and EpiPen Jr Auto-Injectors are intended for immediate self-administration as emergency supportive therapy only and are not intended as a substitute for immediate medical or hospital care.
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.
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