Storage/Transport/How Supplied

The auto-injector is a disposable drug delivery system that contains epinephrine and is used to treat anaphylaxis. It is supplied as a spring-loaded syringe that can be easily transported with you everywhere you go. This disposable system is designed to treat a single anaphylactic episode and must be properly discarded after its use.

The EpiPen^®/EpiPen^® Jr Auto-Injector

 

The EpiPen^® auto-injector is a disposable drug delivery system featuring spring activation and a concealed needle. It is designed for self-administration of epinephrine in acute allergic emergencies (anaphylaxis). It provides a rapid, convenient dose of epinephrine for individuals who need to treat potentially fatal allergic reactions.

EpiPen^® Contains Epinephrine

 

The drug product in EpiPen^® is epinephrine. Epinephrine by injection is the treatment of choice for allergic emergencies (anaphylactic reactions) because it quickly begins working to reverse symptoms of an anaphylactic reaction. It constricts blood vessels, relaxes smooth muscles in the lungs to improve breathing, stimulates the heartbeat, and works to reverse hives and swelling around the face and lips (angioedema). The effects of epinephrine usually last 10 to 20 minutes.

EpiPen^® is Not Reusable

 

Each EpiPen^® auto-injector delivers a single dose of epinephrine. Even though liquid remains inside an auto-injector after use, the unit cannot be used again.

Disposing of EpiPen^® After Use

 

The EpiPen^® auto-injector is intended for emergency use only. After use, you should seek further medical help immediately. At the same time, try to keep warm and avoid unnecessary exertion. The effects of the injection begin to wear off after 10 to 20 minutes; therefore, it is important to seek further medical assistance. If you cannot go to an emergency room, call 911 for assistance. Make sure you inform the health professionals who will treat you that you have given yourself an injection of epinephrine. Take the EpiPen^® auto-injector with you to the hospital emergency room and ask a healthcare professional to dispose of it for you. This will ensure that the healthcare professional knows you have had a shot of epinephrine and what amount you received. To aid in the transport of your EpiPen^® auto-injector to the hospital for disposal, please refer to your patient insert (patient instructions) in the "Directions for use" section.

Indications

EpiPen® and EpiPen Jr® Auto-Injectors (0.3 and 0.15 mg epinephrine) are for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for patients who are at increased risk for these reactions.

EpiPen and EpiPen Jr Auto-Injectors are designed for you to use immediately in an emergency, to treat an allergic reaction fast and give you time to get to a hospital or medical center. EpiPen and EpiPen Jr Auto-Injectors are not a substitute for emergency medical treatment.

Important Safety Information

Each EpiPen Auto-Injector contains a single dose of a medicine called epinephrine, which you inject into your outer thigh. DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective for a severe allergic reaction. In case of accidental injection, please seek immediate medical treatment.

Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects usually go away quickly, especially if you rest. If you have high blood pressure or an overactive thyroid, these side effects may be more severe or longer lasting. If you have heart disease, you could experience chest pain (angina). If you have diabetes, your blood sugar levels may increase after use. If you have Parkinson's disease, your symptoms may temporarily get worse.

Talk to your healthcare professional to find out if you should be prescribed an EpiPen and EpiPen Jr Auto-Injector.

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