EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.

•

Injection: 0.3 mg (0.3 mg/0.3 mL), clear and colorless solution in single-dose pre-filled auto-injector

•

Injection: 0.15 mg (0.15 mg/0.3 mL), clear and colorless solution in single-dose pre-filled auto-injector

None

Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.

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. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see Warnings and Precautions (5.5)].

Cardiovascular Reactions

•

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see Warnings and Precautions (5.5) and Drug Interactions (7)].

•

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions (5.5)].

•

Angina may occur in patients with coronary artery disease [see Warnings and Precautions (5.5)].

•

Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

Reactions from Accidental Injection and/or Improper Technique

•

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see Warnings and Precautions (5.2)].

•

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.

•

Lacerations, 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 [see Warning and Precautions (5.2)].

•

Injection into the buttock has resulted in cases of gas gangrene [see Warnings and Precautions (5.2)].

Skin and Soft Tissue Infections

•

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection, including EpiPen, in the thigh [see Warnings and Precautions (5.3)].

Cardiac Glycosides, Diuretics, and Anti-arrhythmics

Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5)].

Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

Beta-Adrenergic Blockers

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.

Alpha-Adrenergic Blockers

The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine.

Ergot Alkaloids

Ergot alkaloids may also reverse the pressor effects of epinephrine.

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components.

Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution.

Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution.

Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.

Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.

Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.

Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)].

How Supplied

•

EpiPen 2-Pak (epinephrine) injection is supplied with 2 single-dose pre-filled auto-injectors and 1 auto-injector trainer device: 0.3 mg/0.3 mL (NDC 49502-500-02)

•

EpiPen Jr 2-Pak (epinephrine) injection is supplied with 2 single-dose pre-filled auto-injectors and 1 auto-injector trainer device: 0.15 mg/0.3 mL (NDC 49502-501-02)

EpiPen 2-Pak® and EpiPen Jr 2-Pak® also include an S-clip to clip two carrier tubes together.

Storage and Handling

•

Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light.

•

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

•

Do not refrigerate.

•

Before using, check to make sure the solution in the auto-injector is clear and colorless.

•

Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particle.

•

Properly dispose all used, unwanted or expired EpiPen and EpiPen Jr auto-injectors.

See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)

A healthcare provider should review the patient instructions and operation of EpiPen and EpiPen Jr in detail, with the patient or caregiver.

Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used.

Administration

Instruct patients and/or caregivers in the appropriate use of EpiPen and EpiPen Jr. EpiPen should be injected into the middle of the outer thigh (through clothing, if necessary). Each device is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of EpiPen.

Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when EpiPen and EpiPen Jr have been injected into the thigh of young children who are uncooperative and kick or move during an injection [see Warnings and Precautions (5.2)].

Instruct patients and/or caregivers to throw away the blue safety release immediately after using EpiPen and EpiPen Jr. This small part may pose a choking hazard for children.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each EpiPen or EpiPen Jr carton. A printed label on the surface of EpiPen shows instructions for use and a diagram depicting the injection process.

Training

Instruct patients and/or caregivers to use and practice with the Trainer to familiarize themselves with the use of EpiPen in an allergic emergency. The Trainer may be used multiple times. A Trainer device is provided in 2-Pak cartons.

Instruct patients and/or caregivers to immediately place the blue safety release back on the Trainer and reset it after practicing. This small part may pose a choking hazard for children.

Adverse Reactions

Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson’s disease may notice a temporary worsening of symptoms [see Warnings and Precautions (5.5)].

Accidental Injection

Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment should be directed at vasodilatation if there is such an accidental injection to these areas [see Warnings and Precautions (5.2)].

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. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.3)].

Storage and Handling

Instruct patients to inspect the epinephrine solution visually through the clear window of the auto-injector periodically. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. The carrier tube is not waterproof. Instruct patients that EpiPen and EpiPen Jr must be used or properly disposed once the blue safety release is removed or after use [see Storage and Handling (16.2)].

Advise patients and caregivers to give used EpiPen and EpiPen Jr auto-injectors to their healthcare provider for inspection and proper disposal.

Advise patients and caregivers to promptly dispose of medicines that are no longer needed. Dispose of expired, unwanted, or unused EpiPen and EpiPen Jr auto-injectors in an FDA-cleared sharps container. Instruct patients not to dispose EpiPen or EpiPen Jr in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. Inform patients that they can visit the FDA website for additional information on disposal of unused medicines.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each EpiPen Auto-Injector carton.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

EpiPen® and EpiPen Jr® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L. P. of Morgantown, WV 26505, U.S.A.

Copyright © 2020 Meridian Medical Technologies. All rights reserved.

Revised: 12/2020
MS:EPI:R7
0002138

EPIPEN®
(epinephrine injection, USP) Auto-Injector 0.3 mg
EpiPen® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

EPIPEN JR®
(epinephrine injection, USP) Auto-Injector 0.15 mg
EpiPen Jr® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL

For allergic emergencies (anaphylaxis)

Patient Information

Read this Patient Information Leaflet carefully before using the EpiPen® or EpiPen Jr® Auto-Injector and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer EpiPen or EpiPen Jr Auto-Injector, should know how to use it before you have an allergic emergency.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about the EpiPen and EpiPen Jr?

1.

EpiPen and EpiPen Jr are single-dose automatic injection devices (auto-injectors) that contain epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.

 

Symptoms of anaphylaxis may include:

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trouble breathing

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wheezing

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hoarseness (changes in the way your voice sounds)

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hives (raised reddened rash that may itch)

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severe itching

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swelling of your face, lips, mouth, or tongue

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skin rash, redness, or swelling

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fast heartbeat

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weak pulse

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feeling very anxious

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confusion

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stomach pain

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losing control of urine or bowel movements (incontinence)

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diarrhea or stomach cramps

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dizziness, fainting, or “passing out” (unconsciousness)

2.

Always carry your EpiPen or EpiPen Jr with you because you may not know when anaphylaxis may happen.

 

Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your EpiPen or EpiPen Jr and how to use it before you need it. You may be unable to speak in an allergic emergency.

3.

When you have an allergic emergency (anaphylaxis)

•

Use EpiPen or EpiPen Jr right away.

•

Get emergency medical help right away. You may need further medical attention. You may need to use a second EpiPen or EpiPen Jr if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.

What are EpiPen and EpiPen Jr?

•

EpiPen and EpiPen Jr are disposable, pre-filled auto-injectors used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.

•

EpiPen and EpiPen Jr are for immediate self (or caregiver) administration and do not take the place of emergency medical care. You should get emergency help right away after using EpiPen and EpiPen Jr.

•

EpiPen and EpiPen Jr are for people who have been prescribed this medicine by their healthcare provider.

•

The EpiPen Auto-Injector (0.3 mg) is for patients who weigh 66 pounds or more (30 kilograms or more).

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The EpiPen Jr Auto-Injector (0.15 mg) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms).

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It is not known if EpiPen and EpiPen Jr are safe and effective in children who weigh less than 33 pounds (15 kilograms).

What should I tell my healthcare provider before using the EpiPen or EpiPen Jr?

Before you use EpiPen or EpiPen Jr, tell your healthcare provider about all your medical conditions, but especially if you:

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have heart problems or high blood pressure.

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have diabetes.

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have thyroid problems.

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have asthma.

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have a history of depression.

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have Parkinson’s disease.

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are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.

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are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about all of your known allergies.

Especially tell your healthcare provider if you take certain asthma medicines.

EpiPen or EpiPen Jr and other medicines may affect each other, causing side effects. EpiPen or EpiPen Jr may affect the way other medicines work, and other medicines may affect how EpiPen or EpiPen Jr works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Use your EpiPen or EpiPen Jr for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take.

How should I use EpiPen and EpiPen Jr?

•

Each EpiPen or EpiPen Jr Auto-Injector contains only 1 dose of medicine (single-dose).

•

EpiPen and EpiPen Jr Auto-Injectors deliver a fixed dose of epinephrine. The auto-injectors cannot be reused. Do not try to reuse EpiPen or EpiPen Jr after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose has been injected. The dose has been injected if the orange tip is extended and the window is blocked.

•

EpiPen or EpiPen Jr should be injected into the middle of your outer thigh (upper leg). It can be injected through your clothing if needed. Do not inject into a vein or into the buttocks, fingers, toes, hands or feet.

•

Read the Instructions for Use at the end of this Patient Information Leaflet about the right way to use EpiPen and EpiPen Jr.

•

Your healthcare provider will show you how to safely use the EpiPen or EpiPen Jr Auto-Injector.

•

Use your single-dose EpiPen or EpiPen Jr exactly as your healthcare provider tells you to use it. You may need to use a second EpiPen or EpiPen Jr if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.

•

Caution: Never put your thumb, fingers, or hand over the orange tip. Never press or push the orange tip with your thumb, fingers, or hand. The needle comes out of the orange tip. Accidental injection into finger, 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. Tell the healthcare provider where on your body you received the accidental injection.

•

Warning:Do not flip the blue safety release off using a thumb or by pulling it sideways, or by bending and twisting the blue safety release. This may cause the device to activate by accident: a “click” is heard, the orange tip is extended, and the window is blocked. A device that has been activated by accident cannot be used for a patient in an emergency. If this happens, replace it with a new EpiPen or EpiPen Jr.

•

Your EpiPen and EpiPen Jr Auto-Injector may come packaged with an EpiPen Trainer and separate Trainer Instructions for Use. The EpiPen Trainer has a grey color. The grey EpiPen Trainer contains no medicine and no needle. Keep the EpiPen Trainer and the real EpiPen and EpiPen Jr Auto-Injectors away from young children. The real EpiPen and EpiPen Jr Auto-injectors and EpiPen Trainer are not toys. For young children, use of the EpiPen Trainer and the real EpiPen and EpiPen Jr Auto-Injectors should be supervised by an adult. Periodically practice with your EpiPen Trainer before an allergic emergency happens to make sure you are able to safely use the real EpiPen and EpiPen Jr Auto-Injector in an emergency. Always carry your real EpiPen or EpiPen Jr Auto-Injector with you in case of an allergic emergency. Additional training resources are available at www.epipen.com.

•

Do not drop the carrier tube or auto-injector. If the carrier tube or auto-injector is dropped, check for damage and leakage. Throw away (dispose of) the auto-injector and carrier tube and replace if damage or leakage is noticed or suspected.

What are the possible side effects of the EpiPen and EpiPen Jr?

EpiPen and EpiPen Jr may cause serious side effects.

•

The EpiPen or EpiPen Jr should only be injected into the middle of your outer thigh (upper leg). Do not inject the EpiPen or EpiPen Jr into your:

•

veins

•

buttocks

•

fingers, toes, hands, or feet

 

If you accidentally inject EpiPen or EpiPen Jr into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.

•

Rarely, patients who have used EpiPen or EpiPen Jr may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:

•

redness that does not go away

•

swelling

•

tenderness

•

the area feels warm to the touch

•

Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. If you inject a young child with EpiPen or EpiPen Jr, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to:

1.

Hold the young child firmly in place (restrain).

2.

With 1 hand, grip the auto-injector with the orange tip pointing down.

3.

With the other hand, pull the blue safety release straight up and away from the auto-injector.

•

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your EpiPen or EpiPen Jr. Talk to your healthcare provider about all your medical conditions.

Common side effects of EpiPen and EpiPen Jr include:

•

fast, irregular or “pounding” heartbeat

•

sweating

•

headache

•

weakness

•

shakiness

•

paleness

•

feelings of over excitement, nervousness or anxiety

•

dizziness

•

nausea or vomiting

•

breathing problems

These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of the EpiPen or EpiPen Jr. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EpiPen and EpiPen Jr?

•

Store EpiPen and EpiPen Jr at room temperature between 68° F to 77° F (20° C to 25° C).

•

Protect from light.

•

Do not expose to extreme cold or heat. For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.

•

Examine the contents in the clear window of your auto-injector periodically. The solution should be clear. If the solution is discolored (pinkish or brown color) or contains solid particles, replace the unit.

•

Always keep your EpiPen or EpiPen Jr Auto-Injector in the carrier tube to protect it from damage. The carrier tube is not waterproof.

•

The blue safety release helps to prevent accidental injection. Keep the blue safety release on until you need to use EpiPen or EpiPen Jr.

•

Your EpiPen or EpiPen Jr has an expiration date. Replace it before the expiration date. Throw away (dispose of) expired, unwanted, or unused EpiPen and EpiPen Jr in an FDA-cleared sharps disposal container. Do not throw away the EpiPen or EpiPen Jr in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

o

Made of heavy-duty plastic,

o

Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

Upright and stable during use,

o

Leak-resistant, and

o

Properly labeled to warn of hazardous waste inside the container.

 

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

 

 

 

Visit the FDA’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal- unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines.

Keep EpiPen and EpiPen Jr and all medicines out of the reach of children.

General information about the safe and effective use of EpiPen and EpiPen Jr

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use the EpiPen or EpiPen Jr for a condition for which it was not prescribed. Do not give your EpiPen or EpiPen Jr to other people.

This Patient Information Leaflet summarizes the most important information about EpiPen and EpiPen Jr. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about EpiPen and EpiPen Jr that is written for health professionals.

For more information and video instructions on the use of EpiPen and EpiPen Jr, go to www.epipen.com or call 1-800-395-3376.

What are the ingredients in EpiPen and EpiPen Jr?

 

Active Ingredients: Epinephrine

 

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

Important Information

•

The EpiPen Auto-Injector has a yellow colored label.

•

The EpiPen Jr Auto-Injector has a green colored label.

•

The EpiPen Trainer has a grey color and contains no medicine and no needle.

•

Your auto-injector is designed to work through clothing.

•

The blue safety release on the EpiPen and EpiPen Jr Auto-Injector helps to prevent accidental injection of the device. Do not remove the blue safety release until you are ready to use it.

•

Warning: Do not flip the blue safety release off using a thumb or by pulling it sideways, or by bending and twisting the blue safety release. This may cause the device to activate by accident: a “click” is heard, the orange tip is extended, and the window is blocked. A device that has been activated by accident cannot be used for a patient in an emergency. If this happens, replace it with a new EpiPen or EpiPen Jr.

•

When receiving an EpiPen or EpiPen Jr Auto-Injector and before you need to use the EpiPen or EpiPen Jr Auto-Injector, remove the auto-injector from the carrier tube and check the auto-injector to make sure the blue safety release is not raised (see Figure 1 in the Instructions for Use). If the blue safety release is raised, the auto-injector should not be used because the device could activate by accident. Do not try to push the blue safety release back down. Put the auto-injector back in the carrier tube and replace it with a new EpiPen or EpiPen Jr.

•

Choking hazard: The blue safety release is a small part that may become a choking hazard for children. Throw away the blue safety release immediately after using EpiPen and EpiPen Jr Auto-Injector.

•

Only inject into the middle of the outer thigh (upper leg). Never inject into any other part of the body.

•

Never put your thumb, fingers, or your hand over the orange tip. The needle comes out of the orange tip.

•

If an accidental injection happens, get emergency medical help right away.

•

Do not place patient information or any other foreign objects in the carrier tube with the Auto-Injector, as this may prevent you from removing the Auto-Injector for use.

Instructions for Use

EPIPEN®
(epinephrine injection, USP) Auto-Injector 0.3 mg
EpiPen® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

EPIPEN JR®
(epinephrine injection, USP) Auto-Injector 0.15 mg
EpiPen Jr® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL

For allergic emergencies (anaphylaxis)

Read this Instructions for Use carefully before you use EpiPen or EpiPen Jr. Before you need to use your single-dose EpiPen or EpiPen Jr Auto-injector, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer EpiPen or EpiPen Jr Auto-Injector should also understand how to use it as well. If you have any questions, ask your healthcare provider.

Your EpiPen and EpiPen Jr Auto-Injector

When receiving an EpiPen or EpiPen Jr Auto-Injector and before you need to use the EpiPen or EpiPen Jr Auto-Injector, do the following:

•

Remove the EpiPen or EpiPen Jr Auto-Injector from the carrier tube and check the auto-injector to make sure the blue safety release is not raised (see Figure 1). If the blue safety release is not raised, the auto-injector is okay to use. Put the auto-injector back in the carrier tube so that it is ready to be used in an allergic emergency.

•

If the blue safety release is raised (see Figure 2), the auto-injector should not be used because the device could activate by accident. Do not try to push the blue safety release back down. Put the auto-injector back in the carrier tube and replace it with a new EpiPen or EpiPen Jr.

A dose of EpiPen or EpiPen Jr requires 3 steps: Prepare, Administer and Get emergency medical help

          Step 1.  Prepare EpiPen or EpiPen Jr for injection

	Remove the EpiPen or EpiPen Jr from the clear carrier tube.
	Open the yellow cap of your EpiPen or the green cap of your EpiPen Jr carrier tube.
	Tip and slide the auto-injector out of the carrier tube.
	Grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. With your other hand, remove the blue safety release by pulling straight up without bending or twisting it.

 

Warning: Do not flip the blue safety release off using a thumb or by pulling it sideways, or by bending and twisting the blue safety release. This may cause the device to activate by accident: a “click” is heard, the orange tip is extended, and the window is blocked. A device that has been activated by accident cannot be used for a patient in an emergency. If this happens, replace it with a new EpiPen or EpiPen Jr.

 

 

 

Important: The blue safety release is a small part that may become a choking hazard for children. Throw away the blue safety release immediately after using EpiPen or EpiPen Jr.

 

Note:

•

The needle comes out of the orange tip.

•

To avoid an accidental injection, never put your thumb, fingers or hand over the orange tip. If an accidental injection happens, get emergency medical help right away.

         Step 2.  Administer EpiPen or EpiPen Jr

If you are administering EpiPen or EpiPen Jr to a young child, hold the leg firmly in place while administering an injection.
	Place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh. Swing and push the auto-injector firmly until it ‘clicks’. The click signals that the injection has started.
	Hold firmly in place for 3 seconds (count slowly 1,2,3). The injection is now complete.
	Remove the auto-injector from the thigh. The orange tip will extend to cover the needle. If the needle is still visible, do not attempt to reuse it.
	Massage the injection area for 10 seconds.

         Step 3.  Get emergency medical help now.

You may need further medical attention. You may need to use a second EpiPen or EpiPen Jr Auto-Injector if symptoms continue or recur.

•

Take your used auto-injector with you when you go to see a healthcare provider.

•

Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.

•

Give your used EpiPen or EpiPen Jr Auto-Injector to the healthcare provider for inspection and proper disposal.

•

Ask for a refill, if needed.

Note:

•

Keep the EpiPen Trainer and the real EpiPen and EpiPen Jr Auto-injectors away from young children. The real EpiPen and EpiPen Jr Auto-injectors and EpiPen Trainer are not toys. For young children, use of the EpiPen Trainer and the real EpiPen and EpiPen Jr Auto-Injectors should be supervised by an adult.

•

The used auto-injector with extended needle cover will not fit in the carrier tube.

•

EpiPen and EpiPen Jr are single-dose injectable devices that deliver a fixed dose of epinephrine. The auto-injector cannot be reused. Do not attempt to reuse EpiPen after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if the orange tip is extended and the window is blocked.

•

Your EpiPen and EpiPen Jr Auto-Injector may come packaged with an EpiPen Trainer and separate Trainer Instructions for Use. The EpiPen Trainer has a grey color. The grey EpiPen Trainer contains no medicine and no needle. Practice with your EpiPen Trainer, but always carry your real EpiPen or EpiPen Jr Auto-Injector in case of an allergic emergency.

•

If you will be administering EpiPen or EpiPen Jr to a young child, ask your healthcare provider to show you how to first hold the child firmly in place (restrain), use 1 hand to hold the auto-injector with the orange tip pointing down and your other hand to remove the blue safety release to activate the auto-injector, and how to properly hold the leg in place while administering a dose.

•

Do not try to take the EpiPen or EpiPen Jr Auto-Injector apart.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for:

Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

EpiPen® or EpiPen Jr® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L.P. of, Morgantown, WV 26505, U.S.A.

Copyright © 2020 Meridian Medical Technologies. All rights reserved.

Revised: 12/2020
MS:PIL:EPI:R6
0002137

EPIPEN®
(epinephrine injection, USP) Auto-Injector 0.3 mg
EpiPen® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

EPIPEN JR®
(epinephrine injection, USP) Auto-Injector 0.15 mg
EpiPen Jr® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL

MyEpiPen.com

Register your EpiPen or EpiPen Jr Auto-Injector at MyEpiPen.com and find out more about:

•

Free EpiPen Auto-Injector Refill Reminder Program. It is important to keep your auto-injector up-to-date.

Register up to 6 EpiPen or EpiPen Jr Auto- Injectors and receive automatic Refill Reminder Alerts.

•

Receive periodic information related to allergies and allergens.

•

Instructional Video

For more information about EpiPen or EpiPen Jr Auto-Injectors and proper use of the product, call Mylan at 1-877-446-3679 or visit www.epipen.com.

EpiPen Trainer Instructions for Use

In an emergency: Do not use the grey Trainer. Use your real yellow EpiPen® or real green EpiPen Jr® Auto-Injector.

Important Information

•

The Trainer label has a grey color.

•

The Trainer contains no medicine and no needle.

•

Keep the grey Trainer away from young children. The Trainer is not a toy. Young children should only practice with the Trainer under adult supervision.

•

Periodically practice with the grey Trainer before an allergic emergency (anaphylaxis) happens to make sure you are able to safely use the real yellow EpiPen or real green EpiPen Jr Auto-Injector in case of an emergency.

•

Always carry your real yellow EpiPen or real green EpiPen Jr Auto-Injector in case of an allergic emergency.

•

When receiving the real yellow EpiPen or real green EpiPen Jr Auto-Injector and before you need to use the real yellow EpiPen or real green EpiPen Jr Auto-Injector, check the auto-injector to make sure the blue safety release is not raised (see Patient Information Leaflet). If the blue safety release is raised, the auto-injector should not be used because the device could activate by accident. Do not try to push the blue safety release back down. Put the auto-injector back in the carrier tube and replace it with a new real yellow EpiPen or real green EpiPen Jr.

•

Small parts like the blue safety release may become a choking hazard for children. Put the blue safety release back on the Trainer and reset it immediately after practicing.

The EpiPen Trainer

Familiarize yourself with this grey Trainer. Practice until you are comfortable using it.

Your grey Trainer:

•

Never put your thumb, other fingers, or hand over the orange tip.

•

The orange tip is where the needle comes out of your EpiPen or EpiPen Jr Auto-Injector.

Practice Instructions

	1 Prepare the Trainer for Simulated Injection
	• Grasp the grey Trainer in your fist with the orange tip pointing downward. • With your other hand, remove blue safety release by pulling straight up without bending or twisting it. • Removing the blue safety release unlocks the Trainer. Warning: Do not flip the blue safety release off using a thumb or by pulling it sideways, or by bending and twisting the blue safety release. This may cause the real yellow EpiPen or real green EpiPen Jr auto-injector to accidentally activate. An EpiPen or EpiPen Jr auto-injector that has been activated by accident cannot be used for a patient in an emergency and must be replaced.
	2 Administer the Trainer Simulation.
• If practicing with a young child, hold the leg firmly in place while using the EpiPen Trainer. Ask your healthcare provider to show you how to first hold the child firmly (restrain) and then use 1 hand to hold the Trainer with the orange tip pointing down and your other hand to remove the blue safety release, and how to properly hold the leg to practice so that you will be prepared before an allergic emergency happens.
	• Place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh. • Swing and push the Trainer firmly until it ‘clicks.’ The click signals that the injection has started.
	• Hold firmly in place for 3 seconds (count slowly 1,2,3). • Remove the Trainer from the thigh and massage the injection area for 10 seconds. The orange tip automatically extends out after use.
	Note: • In an actual emergency, you would need to seek emergency medical help right away. • The actual auto-injector is made to work through clothing. • Do not inject into any other part of the body.
	3 To reset the Trainer
	• Put the blue safety release back on the Trainer. • Place the orange tip on a hard surface. • Squeeze the sides of the orange tip and push down on the Trainer with the other hand.

Note: With the real yellow EpiPen or real green EpiPen Jr Auto-Injector, the orange tip covers the needle after self-injection to help protect you from accidentally sticking yourself or others.

Practice Session Information

In case of an allergic emergency, use the real yellow EpiPen or real green EpiPen Jr Auto-Injector and not the grey Trainer.

Follow instructions above. Repeat as often as needed until you are able to self-inject quickly and correctly.

Reread:

•

The Trainer Instructions for Use

•

The “Patient Information” that comes with your EpiPen or EpiPen Jr Auto-Injector

Train others who could help you in an emergency:

•

Your parents, caregivers, and others who may be in a position to administer EpiPen or EpiPen Jr should know how to help you during an allergic emergency (anaphylaxis). Before an emergency occurs, have them:

•

Practice activating the Trainer

•

Read these Trainer Instructions and the “Patient Information”

For more information about the EpiPen and EpiPen Jr Auto-Injector and the proper use of the products, go to www.epipen.com.

Caution:

Important differences between the Trainer and your real yellow EpiPen or real green EpiPen Jr Auto-Injector

	Trainer (Grey)	EpiPen (Yellow)	EpiPen Jr (Green)
Contains medicine?	No	Yes	Yes
Has needle?	No	Yes	Yes
Comes in Carrier Tube?	No	Yes	Yes
Color of Label?	Grey	Yellow	Green
Has expiration date?	No	Yes	Yes
Can be reused?	Yes	No (use only one time)	No (use only one time)
Okay to remove and replace safety release?	Yes	No (remove just one time before use)	No (remove just one time before use)
Pressure needed to hold against thigh?	Moderate	Strong	Strong

This Trainer Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

EpiPen® and EpiPen Jr® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L. P. of Morgantown, WV 26505, U.S.A.

Copyright © 2020 Meridian Medical Technologies. All rights reserved.

Revised: 12/2020
MS:EPIT:R7
0002139

NDC 49502-500-02

Rx only

For Allergic Emergencies (Anaphylaxis)

EpiPen 2-PAK®
(epinephrine injection, USP)
Single-Dose Auto-Injectors 0.3 mg

Each carton contains:

The EpiPen Auto-Injector and Trainer are not toys and should be used under adult supervision.

Never put thumb, fingers or hand over orange tip.
Do not remove blue safety release until ready to use.

EpiPen 2-Pak® contains 2 EpiPen® Auto-Injectors and 1 Trainer.

Each EpiPen® Auto-Injector delivers one 0.3 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.3 mg/0.3mL. Each 0.3 mL also contains 1.8 mg sodium chloride and 0.5 mg sodium metabisulfite.

Discard unit after use. The Trainer contains no medicine and no needle.

Read enclosed patient package insert carefully before using.

Usual dosage: See insert.

See enclosed Patient Information Leaflet for complete instructions for use.

Note: The needle comes out of the orange tip.

Never put your thumb, fingers or hand
over the orange tip.

Replace if discolored. Store at 68º to 77ºF
(20º to 25ºC). Do not refrigerate.

Protect from light.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, USA
by Meridian Medical Technologies, Inc.,
Columbia, MD 21046, USA, a Pfizer company

EpiPen® and EpiPen Jr® are registered trademarks of
Mylan Inc. licensed exclusively to its wholly-owned
affiliate, Mylan Specialty L.P. of Morgantown, WV 26505, USA

Copyright © 2020 Meridian Medical Technologies. All rights reserved.

0002096
MS:50002:2C:R5

NDC 49502-501-02

Rx only

For Allergic Emergencies (Anaphylaxis)

EpiPen Jr 2-PAK®
(epinephrine injection, USP)
Single-Dose Auto-Injectors 0.15 mg

Each carton contains:

The EpiPen Jr Auto-Injector and Trainer are not toys and should be used under adult supervision.

Never put thumb, fingers or hand over orange tip.
Do not remove blue safety release until ready to use.

EpiPen Jr 2-Pak® contains 2 EpiPen Jr® Auto-Injectors and 1 Trainer.

Each EpiPen Jr® Auto-Injector delivers one 0.15 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL. Each 0.3 mL also contains 1.8 mg sodium chloride and 0.5 mg sodium metabisulfite.

Discard unit after use. The Trainer contains no medicine and no needle.

Read enclosed patient package insert carefully before using.

Usual dosage: See insert.

See enclosed Patient Information
Leaflet for complete instructions for use.

Note: The needle comes out of the orange tip.

Never put your thumb, fingers or hand
over the orange tip.

Replace if discolored. Store at 68º to 77ºF
(20º to 25ºC). Do not refrigerate.

Protect from light.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, USA
by Meridian Medical Technologies, Inc.,
Columbia, MD 21046, USA, a Pfizer company

EpiPen® and EpiPen Jr® are registered trademarks of
Mylan Inc. licensed exclusively to its wholly-owned
affiliate, Mylan Specialty L.P. of Morgantown, WV 26505, USA

Copyright © 2020 Meridian Medical Technologies. All rights reserved.

0002097
MS:50102:2C:R5