History doesn’t always prepare us for the future.
Anaphylaxis is unpredictable. The severity of future anaphylactic reactions cannot be accurately predicted based on the level of sIgE, the size of the skin prick test wheal or the severity of past reaction.1,2 In addition:
- Up to 20% of children will not have cutaneous symptoms during an anaphylactic reaction3
- Involvement of body organ systems in anaphylaxis varies among patients, and even in the same patient from one allergic reaction to another4-6
EPIPEN and EPIPEN JR® (epinephrine injection, USP) and their authorized generic auto-injectors
Viatris' branded and authorized generic auto-injectors are used for the emergency treatment of the signs and symptoms of anaphylaxis, including pruritus, urticaria, angioedema, flushing, syncope, tachycardia and dyspnea due to laryngeal spasm and/or a decrease in blood pressure. Anaphylaxis can be caused by triggers such as food, biting or stinging insects, medicines, latex or even radiocontrast media and exercise.5-9
For over 35 years, nearly 80 million EPIPEN auto-injectors have been dispensed*
*Based on IQVIA data from 1987-March 2022.
Watch a step-by-step video for patients on how to use the EPIPEN Auto-Injector and its authorized generic.
Watch our step-by-step video showing how to use the device.
The single dose EPIPEN or EPIPEN JR Auto-Injector is for allergic emergency anaphylaxis and should be used right away.
You can use a second EPIPEN or EPIPEN JR Auto-Injector if symptoms continue or if symptoms come back.
Checking the Blue Safety Top
When receiving an EPIPEN or EPIPEN JR Auto-Injector and before you need to use the EPIPEN or EPIPEN JR Auto-Injector, remove the EPIPEN or EPIPEN JR Auto-Injector from the protective case and check the auto-injector to make sure the blue safety top is not raised.
If the blue safety top is not raised, the auto-injector is okay to use.
Put the auto-injector back in the protective case so that it is ready to be used in an allergic emergency.
If the blue safety top is raised, the auto-injector should not be used because the device could activate by accident. Do not try to push the blue safety top back down.
Put the auto-injector back in the protective case and replace it with a new EPIPEN or EPIPEN JR.
Preparing to inject EPIPEN or EPIPEN JR.
Check the auto-injector before use.
If the auto-injector appears damaged, throw it away or dispose of and do not use.
Check the medicine viewing window.
Use the medicine if it is clear and colorless.
Do not use the medicine if it is discolored or pinkish or brown color, or if the medicine has particles floating in it, throw it away or dispose of and use a new EPIPEN or EPIPEN JR Auto-Injector.
Injecting EPIPEN or EPIPEN JR
Slide the EPIPEN or EPIPEN JR Auto-Injector out of the protective case.
Remove the auto-injector from the protective case. Pull off the blue safety top.
Grip the EPIPEN or EPIPEN JR Auto-Injector with one hand and with the orange needle end pointing down.
Use the other hand to remove the blue safety top. Pull it straight up and away.
Note: Do not flip the blue safety top off using a thumb or by pulling it sideways, or by bending and twisting the blue safety top.
Failure to pull out the blue safety top correctly or straight up and away can cause accidental activation.
To avoid an accidental injection, never put your thumb, fingers, or hand over the orange needle end.
If an accidental injection happens, get emergency medical help right away.
Inject the Medicine.
Place the orange needle end against the outer thigh through clothing if needed.
Push down firmly and hold in place for three seconds.
EPIPEN and EPIPEN JR Auto-Injectors make a distinct pop sound when pushed against the thigh.
This is normal and means that the EPIPEN or EPIPEN JR Auto-Injector is working.
After the pop, continue to press the EPIPEN or EPIPEN JR Auto-Injector down firmly on the outer thigh for three seconds to make sure that the medicine is given.
Caregiver Administration.
If you are giving EPIPEN or EPIPEN JR to a young child, first hold the child firmly in place or restrain and then use both hands to remove the blue safety top as shown.
Use one hand to hold the auto-injector with the orange needle end pointing down and your other hand to remove the blue safety top to activate the auto-injector.
Then inject in the middle of the outer thigh.
Remember to hold the leg firmly in place before and during the three second injection to avoid needle stick injuries, including cuts to the thigh.
Check if used
Lift the auto-injector straight out from the thigh. The orange needle end will extend to cover the needle. If the needle is visible, do not reuse it, use a new auto-injector.
Throw away the blue safety top.
The blue safety top is a small part that may become a choking hazard for children and it should be thrown away immediately after using the auto-injector.
Get Emergency Medical Help
After injecting EPIPEN or EPIPEN JR, get emergency medical help right away.
You can use a second EPIPEN or EPIPEN JR Auto-Injector if symptoms continue or come back.
Take your used EPIPEN or EPIPEN JR Auto-Injector to your healthcare provider.
EPIPEN or EPIPEN JR are single dose auto-injectors and cannot be reused. If the needle is visible, do not try to reuse it.
For more information on how to throw away or dispose of your auto-injector, see the section ‘Disposing of an Expired, Unused, or used EPIPEN or EPIPEN JR Auto-Injector’ in the Patient Information Leaflet.
The real EPIPEN and EPIPEN JR Auto-Injectors are not toys. Use by young children should be supervised by an adult.
Keep the trainer and the real EPIPEN and EPIPEN JR Auto-Injectors away from young children.
Always carry your two auto-injectors because one dose may not be enough.
If you need more than two doses of epinephrine for a single anaphylaxis episode, more doses must be administered by a healthcare professional.
Before you use your EPIPEN or EPIPEN JR Auto-Injector, make sure your healthcare provider shows you the right way to use it.
Practice with the gray trainer before an allergic emergency happens to make sure you can safely use the real EPIPEN in an emergency. The gray trainer contains no medicine and no needle.
Note: This ‘How to Use’ video is intended to provide an overview and basic information about the EPIPEN Auto-Injector and does not replace the Instructions for Use.
Please continue to watch for Important Safety Information about EPIPEN Auto-Injector.
Indications or the following information applies to both EPIPEN and its authorized generic.
EPIPEN and EPIPEN JR Auto-Injectors are used to treat life threatening allergic emergencies in people who are at risk for or have a history of serious allergic emergencies.
EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver.
They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN or EPIPEN JR.
Important Safety Information or the following information applies to both EPIPEN and its Authorized Generic.
EPIPEN or epinephrine injection USP 0.3 milligrams and EPIPEN JR or epinephrine injection USP 0.15 milligram auto-injectors are used to treat allergic emergencies or anaphylaxis. Anaphylaxis can be life threatening and happen within minutes. If untreated, anaphylaxis can cause death.
This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.
Always carry two EPIPEN or two EPIPEN JR Auto-Injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.
When you have an allergic emergency or anaphylaxis, use EPIPEN or EPIPEN JR Auto-Injectors right away. Get emergency medical help right away even if you have used the EPIPEN or EPIPEN JR Auto-Injector. You can use a second EPIPEN or EPIPEN JR Auto-Injector if symptoms continue or if the first auto-injector is activated.
If you need more than two doses for an allergic emergency, they must be given by a healthcare provider.
Before you use EPIPEN or EPIPEN JR Auto-Injectors, tell your healthcare provider about all your medical conditions if you have heart problems with high blood pressure, diabetes, thyroid problems, asthma, a history of depression, Parkinson's disease, are pregnant or plan to become pregnant or breastfeeding or plan to breastfeed.
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.
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 Auto-Injector.
Especially, tell your healthcare provider if you take certain asthma medicines. EPIPEN and EPIPEN JR and other medicines may affect the way other medicines work.
Other medicines may affect how EPIPEN and EPIPEN JR Auto-Injector works.
EPIPEN or EPIPEN JR Auto-Injector should be injected into the middle of your outer thigh or upper leg through clothing if necessary.
Do not inject into your veins, buttocks, fingers, toes, hands or feet.
It is very important that you hold the EPIPEN or EPIPEN JR Auto-Injector down firmly on the middle of the outer thigh or upper leg for at least three full seconds.
If you do not hold it in place long enough, the EPIPEN or EPIPEN JR Auto-Injector might not have time to deliver the correct dose of medicine.
If you accidentally inject EPIPEN or EPIPEN JR Auto-Injectors into any place other than the middle of your outer thigh, go to the nearest emergency room right away.
If you inject a young child, hold their leg firmly in place before and during the three second injection to prevent injuries.
Rarely, patients who have used EPIPEN or EPIPEN JR Auto-Injectors may get infections at the injection site within a few days. Some of these infections can be serious.
Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.
Common side effects include fast, irregular or pounding heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects may go away with rest.
Tell your healthcare professional if you have any side effects that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information and Patient Information for EPIPEN.
Please see the full Prescribing Information and Patient Information for the Authorized generic for EPIPEN.
Important Training Reminders
Access to two for your patients
EPIPEN, EPIPEN JR and their authorized generic auto-injectors are available in cartons of two.8,9 Up to 20% of patients need additional doses due to a biphasic reaction or protracted symptoms.1,6 According to national food allergy guidelines, it is recommended to have access to two epinephrine auto-injectors, which provides two sequential doses if needed during an anaphylactic reaction.1 Each carton also includes a Trainer, which may be valuable in promoting patient familiarity with the administration of EPIPEN Auto-Injector or its authorized generic.8,9
Special Offers
Explore the latest savings offers for EPIPEN (epinephrine injection, USP) Auto-Injectors and the Authorized Generic for EPIPEN. See Terms and Conditions.
There’s only one recommended first-line treatment for anaphylaxis.
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Important Safety Information (the following information applies to both EPIPEN and its Authorized Generic)
EPIPEN (epinephrine injection, USP) 0.3 mg and EPIPEN JR (epinephrine injection, USP) 0.15 mg Auto-Injectors are intended for immediate administration as emergency supportive therapy only and are not intended as a substitute for immediate medical or hospital care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.
Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection.
Important Safety Information (the following information applies to both Epipen and its Authorized Generic)
EPIPEN (epinephrine injection, USP) 0.3 mg and EPIPEN JR (epinephrine injection, USP) 0.15 mg Auto-Injectors are intended for immediate administration as emergency supportive therapy only and are not intended as a substitute for immediate medical or hospital care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.
EPIPEN and EPIPEN JR should only be injected into the anterolateral aspect of the thigh. Do not inject intravenously, into buttock, or into digits, hands, or feet. Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection to minimize risk of injection-related injury.
Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop symptoms of infection such as persistent redness, warmth, swelling, or tenderness at the injection site.
Epinephrine should be used with caution in patients with heart disease, 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, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.
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. Common adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
Indications (the following information applies to both EPIPEN and its Authorized Generic)
EPIPEN and EPIPEN JR Auto-Injectors 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 Auto-Injectors 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.
Click here for Full Prescribing Information for EPIPEN.
Click here for Full Prescribing Information for the Authorized Generic for EPIPEN.
EPIPEN, EPIPEN JR, EPIPEN JR. 2-PAK, EPIPEN4SCHOOLS, NEVER-SEE-NEEDLE and the EpiPen / EpiPen Jr Logo are registered trademarks of Mylan Inc., a Viatris Company. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. All other trademarks and service marks are the property of their respective owners. This website is intended for residents of the United States who will prescribe or fill prescriptions for patients located within the United States.
© 2024 Viatris Inc. All Rights Reserved. EPI-2021-0172 V7
References
- Boyce JA, Assa’ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58.
- Simons FE. Anaphylaxis: recent advances in assessment and treatment. J Allergy Clin Immunol. 2009;124(4):625-636.
- Järvinen KM, Celestin J. Anaphylaxis avoidance and management: educating patients and their caregivers. J Asthma Allergy. 2014;7:95-104.
- Dinakar C. Anaphylaxis in children: current understanding and key issues in diagnosis and treatment. Curr Allergy Asthma Rep. 2012;12(6):641-649.
- Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis—a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015;115(5):341-384.
- Simons FE. Anaphylaxis. J Allergy Clin Immunol. 2010;125(2)(suppl 2):S161-S181.
- Volcheck GW. Clinical Allergy: Diagnosis and Management. Rochester, MN: Mayo Foundation for Medical Education and Research; 2009.
- EPIPEN (epinephrine) injection. Prescribing & Patient Information. 2023. Mylan Specialty L.P. Morgantown WV.
- EPINEPHRINE (epinephrine) injection. Prescribing & Patient Information. 2023. Mylan Specialty L.P. Morgantown.
- Data on file: IMS Report (1987-September 2020). (Data includes prescriptions for the authorized generic of EPIPEN and EPIPEN JR.).
- Ram FSF, Hoare K, Arroll B, Hoare S. Epinephrine self-administration in anaphylactic emergencies: comparison of commonly available autoinjectors. J Asthma Allergy Educ. 2012;3(4):178-181.
EPIPEN, EPIPEN JR, EPIPEN JR. 2-PAK, EPIPEN4SCHOOLS, NEVER-SEE-NEEDLE and the EpiPen / EpiPen Jr Logo are registered trademarks of Mylan Inc., a Viatris Company. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. All other trademarks and service marks are the property of their respective owners. This website is intended for residents of the United States who will prescribe or fill prescriptions for patients located within the United States.
© 2024 Viatris Inc. All Rights Reserved. EPI-2021-0172 V7
Prescribing Information
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Patient Information
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