Epinephrine Injection, USP Auto-Injectors, the Authorized Generics to EpiPen (epinephrine injection, USP) Auto-Injectors

The authorized generic to EpiPen®
(epinephrine injection, USP) Auto-Injector

Talk to your healthcare professional about Epinephrine Injection, USP Auto-Injector, the authorized generic to EpiPen® Auto-Injector, for people who have a history of, or an increased risk of, a life-threatening allergic reaction (anaphylaxis). They are self-injectable devices (auto-injectors) that contain epinephrine, the first-line treatment for anaphylaxis, and come in two dosages — 0.3 mg and 0.15 mg.

If you have the authorized generic, your product is not affected by the EpiPen recall announced on 3/31/2017. Please click here for more information.

Save up to $25 on Mylan's Ephinephrine Injection, USP Auto-Injectors

The MyGenericEAI Savings Card can provide up you with $25 in savings per auto-injector two-pack.

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*Eligibility restrictions apply. See Terms and Conditions. This offer is not valid for patients covered by Medicare, Medicaid or any other federal or state funded healthcare program or where prohibited by law. Mylan Specialty L.P. reserves the right to amend or end this program at any time without notice.
Get to know Epinephrine Injection, USP Auto-Injectors
Get to know Epinephrine Injection, USP Auto-Injectors
  • What is an authorized generic?

    According to the FDA, the only difference between an authorized generic and a brand name product is the label. They are exactly the same, except the authorized generic does not bear the branded name. A company can create and sell an authorized generic of a branded product it already produces under a previously approved New Drug Application (NDA).

  • What does that mean for you?

    Mylan is launching the first authorized generic to EpiPen® Auto-Injector at a list price of $300 per generic EpiPen® two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (“WAC”), of the branded medicine.

    The device functionality and drug formulation are identical to the branded medicine. Mylan is distributing the authorized generic as it would any other generic medicine working with all parts of the generic drug value chain. Savings for the patient will be determined by their healthcare insurance coverage.

  • What is epinephrine?

    You’ve probably heard of epinephrine under it’s non-technical name—adrenaline. When you ride a roller coaster or give a presentation, you may feel your heart beat a little faster, your breath intake increases and a sudden burst of energy. That’s adrenaline at work, a substance your body naturally releases under stress. And the medicine inside your epinephrine auto-injectors happens to be a synthetic version of adrenaline—epinephrine.

  • Why epinephrine?

    According to national food allergy guidelines, epinephrine is the only recommended first-line treatment for life-threatening allergic reactions. It constricts blood vessels to increase blood pressure, relaxes smooth muscles in the lungs to reduce wheezing and improve breathing, stimulates the heart (increases heart rate) and works to reduce hives and swelling that may occur around the face and lips.

You may be eligible to obtain the authorized generic for EpiPen® through the Patient Access Program, administered and distributed by ASPN’s Pharmacy Network, at a cost of $300. Please note that in most circumstances you may be able to fill your prescription for the authorized generic at your retail pharmacy. Please check with your retail pharmacy first to determine authorized generic availability and cost. If the product cost is greater than $300, please call the following number 844-357-3969 for further information.

IMPORTANT SAFETY INFORMATION

Use Epinephrine Injection, USP 0.3 mg or Epinephrine Injection, USP 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. Epinephrine Injection, USP Auto-Injector should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used Epinephrine Injection, USP Auto-Injector may develop an infection 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.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. 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 Epinephrine Injection, USP Auto-Injector.

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 usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and Patient Information.

INDICATIONS

Epinephrine Injection, USP Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. Epinephrine Injection, USP Auto-Injectors are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.

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.

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IMPORTANT SAFETY INFORMATION

Use Epinephrine Injection, USP 0.3 mg or Epinephrine Injection, USP 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode.

IMPORTANT SAFETY INFORMATION

Use Epinephrine Injection, USP 0.3 mg or Epinephrine Injection, USP 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. Epinephrine Injection, USP Auto-Injector should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used Epinephrine Injection, USP Auto-Injector may develop an infection 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.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. 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 Epinephrine Injection, USP Auto-Injector.

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 usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and Patient Information.

INDICATIONS

Epinephrine Injection, USP Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. Epinephrine Injection, USP Auto-Injectors are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.

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.

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