EpiPen

An EpiPen (epinephrine) is an auto-injector used to treat life-threatening, emergency allergic reactions (anaphylaxis) from food, insect stings, or allergens. EpiPen should be used immediately at the first signs of anaphylaxis to reduce throat swelling, open airways, and restore blood pressure, reversing these severe life-threatening symptoms.

Anaphylaxis is a medical emergency, and you must seek emergency medical treatment right away, even if you have used the EpiPen or EpiPen Jr auto-injector.

EpiPen Auto-Injectors should be kept on hand for self-injection by a person with a history of severe allergic reactions.

• Step 1. Twist to remove the safety cap.
• Step 2. Firmly push the orange tip of the auto-injector against the outer thigh and hold in place for 3 seconds.

For more detailed instructions, see the "How to use an EpiPen" section below

With the EpiPen device, you can quickly inject epinephrine (adrenaline) into the outer thigh to treat anaphylaxis. The medicine works by stimulating alpha- and beta-adrenergic receptors to narrow blood vessels, which raises low blood pressure, and relaxes the muscles in the airways, which helps reduce swelling and makes breathing easier. This rapid response can slow or reverse the most dangerous symptoms of a severe allergic reaction and gives the person vital time to get emergency medical care.

How to Use an EpiPen Auto-Injector

• Form a fist around the Auto-Injector with the orange end pointing down. Pull the blue safety top straight up and away from the auto-injector. Place the orange tip against the fleshy portion of the outer thigh. You may give the injection directly through your clothing. Do not put your thumb over the end of the unit. Hold the leg firmly when giving this injection to a child or infant.
• Push the Auto-Injector firmly against the outer thigh and hold the device down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the device might not have time to deliver the correct dose of medicine.
• Remove the Auto-Injector from the thigh.
• The EpiPen has been activated when the blue safety top is removed and a “pop” is heard, the orange needle end of the auto-injector is extended, or the medicine viewing window is blocked.
• Carefully re-insert the used device needle-first into the carrying tube. Re-cap the tube and take it with you to the emergency room so that anyone who treats you will know how much epinephrine you have received.

If you accidentally inject yourself while giving an epinephrine injection to another person, you must seek medical attention.

Accidental injection into fingers, hands, or feet may cause a loss of blood flow to these areas. If an accidental injection happens, go immediately to the nearest emergency room.

Use an Auto-Injector only once, then throw it away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not try to reuse the same Auto-Injector a second time. If the needle is bent from the first use, it may cause serious injury to your skin.

Do not use the EpiPen if it has changed colors or has any particles in it, or if the expiration date on the label has passed. Call your doctor for a new prescription.

Your medicine may also come with a "trainer pen." The trainer pen contains no medicine and no needle. It is only for non-emergency use to practice giving yourself an injection.

General Information

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

The EpiPen Auto-Injector device is a disposable, single-use system. An Auto-Injector can only be used one time. You may need to use a second EpiPen auto-injector if symptoms continue or come back while you wait for emergency help or if the first auto-injector is activated before the dose can be given.

Do not remove the safety cap until you are ready to use the Auto-Injector. Never put your fingers over the injector tip after the safety cap has been removed.

Do not give this medicine to a child without medical advice.

EpiPen is injected into the skin or muscle of your outer thigh. In an emergency, this injection can be given through your clothing. Do not inject into a vein or into the buttocks, fingers, toes, hands or feet.

Seek emergency medical attention even after you use an epinephrine injection to treat a severe allergic reaction. You will need to receive further treatment and observation.

Tell your doctor if a previous injection caused a serious side effect, such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

It is recommended that patients at risk of anaphylaxis carry two auto-injectors in case the first auto-injector is activated before the dose can be given, or if a second dose.

You may not know when anaphylaxis will happen. Talk to your healthcare provider if you need more auto-injectors to keep at work, school, or other locations. Make sure your family members, caregivers, and others know where you keep your EpiPen and how to use it before you need it. You may be unable to speak in an allergic emergency.

A “trainer pen” is available to teach and practice giving an injection. The trainer pen contains no medicine and no needle.

Before using an injection, tell your doctor if any past use has caused an allergic reaction to get worse.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease or high blood pressure;
• asthma;
• Parkinson's disease;
• depression or mental illness;
• a thyroid disorder; or
• diabetes.

Pregnancy and breastfeeding

Having an allergic reaction while pregnant or nursing could harm both mother and baby.

You may need to use an epinephrine injection during pregnancy or while you are breastfeeding. Seek emergency medical attention right away after using the injection. Epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy and breastfeeding. Epinephrine should be used for the treatment of anaphylaxis during pregnancy and breastfeeding in the same manner as it is used in non-pregnant and non-breastfeeding patients.

If possible, during an emergency, tell your medical caregivers if you are pregnant or breastfeeding.

Common EpiPen side effects

Common EpiPen side effects may include:

• breathing problems;
• fast, irregular, or pounding heartbeats;
• pale skin, sweating;
• nausea and vomiting;
• dizziness;
• weakness or tremors;
• headache; or
• feeling restless, fearful, nervous, anxious, or excited.

Other EpiPen side effects

Cardiovascular Reactions

• Cardiac problems, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain medications.
• Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease.
• Angina may occur in patients who have coronary artery disease.
• Rare cases of stress cardiomyopathy have been reported in patients who have been treated with epinephrine.

Skin and Soft Tissue Infections

• Injection site infections have been reported following epinephrine injection including rare cases of serious skin and soft tissue infections, such as necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene). Call your doctor at once if you notice pain, swelling, warmth, redness, or other signs of infection around the area where you gave an injection.

Reactions from Accidental Injection and/or Improper Technique

• Accidental injection into the fingers, toes, hands, or feet may result in loss of blood flow to the affected area. The patient should go immediately to the nearest emergency room and 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.
• Adverse reactions 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.
• Scratches, bent needles, and embedded needles have been reported when EpiPen has been injected into the thigh of young children who are uncooperative and kick or move during the injection.
• Injection into the buttock has resulted in cases of gas gangrene.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Anaphylaxis is a life-threatening allergic reaction to insect stings or bites, foods, drugs, exercise-induced anaphylaxis, and other allergens. Anaphylaxis can happen within minutes and, left untreated, can lead to death.

Symptoms of anaphylaxis may include:

• trouble breathing
• wheezing
• hoarseness (changes in the way your voice sounds)
• swelling of your face, lips, mouth, or tongue
• hives (raised reddened rash that may itch)
• severe itching
• skin rash, redness, or swelling
• fast heartbeat
• weak pulse
• feeling very anxious
• confusion
• stomach pain
• losing control of urine or bowel movements (incontinence)
• diarrhea or stomach cramps
• dizziness, fainting, or “passing out” (unconsciousness).

Anaphylaxis is treated with epinephrine injections such as EpiPen, but you must seek emergency medical treatment right away, even if you have used the epinephrine injections.

Usual dose for patients over 30kg (66 lbs): EpiPen 0.3 mg.

Usual dose for patients 15 to 30 kg (33 lbs to 66 lbs): EpiPen Jr 0.15 mg.

With severe, persistent anaphylaxis, repeat injections with an additional EpiPen may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision

Inject intramuscularly or subcutaneously into the outer thigh, through clothing if necessary. Each device is a single-dose injection.

EpiPens are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. The patient should seek immediate medical or hospital care in conjunction with the administration of epinephrine.

EpiPen is available as:

• EpiPen Auto-Injector 0.3 mg (0.3 mg/0.3 mL) single-dose pre-filled auto-injector
• EpiPen Jr Auto-Injector: 0.15 mg (0.15 mg/0.3 mL) single-dose pre-filled auto-injector.

Since this medicine is used when needed, it has no daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include numbness or weakness, severe headache, blurred vision, pounding in your neck or ears, sweating, chills, chest pain, fast or slow heartbeats, severe shortness of breath, or cough with foamy mucus.

EpiPen coupons or savings cards may help you save money on EpiPens. You may save up to $300 per 2-PAK carton, up to a maximum of three 2-PAK cartons, if you qualify for the savings card. More information and links are available on the EpiPen Prices, Coupons, Copay Cards & Patient Assistance page.

Do not inject EpiPen into a finger, toes, hands, feet, vein, or the muscles of your buttocks, or it may not work as well. Seek immediate emergency help if you have injected it into the wrong area. Inject only into the fleshy outer portion of the thigh.

Tell your doctor about all your other medicines, especially:

• asthma medicine;
• an antidepressant;
• cold or allergy medicine (Benadryl and others);
• heart or blood pressure medicine;
• thyroid medication; or
• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine.

This list is not complete. Other drugs may interact with epinephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store at room temperature between 68° F to 77° F (20° C to 25° C).
• Do not expose it to extreme cold or heat. For example, do not store it in your vehicle’s glove box or trunk. Do not store in the refrigerator or freezer.
• Keep this medicine out of the sight and reach of young children.
• Keep a protective case in the outer carton to protect from light. When exposed to air or light epinephrine changes quickly to a pinkish or brown color and should not be used.
• Examine the contents in the medicine viewing window of your auto-injector regularly. The medicine should be clear. If the medicine is discolored (pinkish or brown color) or contains solid particles, replace the auto-injector.
• Always keep your auto-injectors in the protective cases to prevent damage to the device. The protective case is not waterproof.
• The blue safety top helps to prevent accidental injection. Keep the blue safety top in place until you need to use the auto-injector. After the auto-injector is used, throw away the blue safety top as this may pose a choking hazard for small children.

Active Ingredients: epinephrine

Inactive Ingredients: sodium chloride, sodium metabisulfite, hydrochloric acid, and water

EpiPen Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, LLC, St. Louis, MO 63146, U.S.A.