BX Rating

BX Rating

Epinephrine auto-injectors are used for the emergency treatment of potentially life-threatening anaphylactic reactions, and each has a different design and operating instructions for use under stressful conditions.1-3 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 the data reviewed are insufficient to determine therapeutic equivalence. This rating indicates that other epinephrine auto-injector products have not been determined to be therapeutically equivalent to the EpiPen® (epinephrine) Auto-Injector.4

Dispensing a different auto-injector than prescribed could create confusion for the patient when administering epinephrine, according to Ram et al.5

To view the FDA’s Orange Book, please click here

Indications

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.

Important Safety Information

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.

For additional information please contact us at 800-395-3376.