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

Epinephrine Injection, USP Auto-Injector is the authorized generic to EpiPen® Auto-Injector, indicated for the emergency treatment of the signs and symptoms of anaphylaxis, including pruritus, urticarial, angioedema, flushing, syncope, tachycardia and dyspnea due to laryngeal spasm and/or a decrease in blood pressure.1


What is an authorized generic?

According to the Food and Drug Administration (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.5 A company can create and sell an authorized generic of a branded product it already produces under a previously approved New Drug Application (NDA).5


What does that mean for patients?

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


INDICATIONS

Epinephrine Injection, USP Auto-Injectors are indicated in the emergency treatment of Type I allergic reactions, including anaphylaxis, to allergens, idiopathic and exercise-induced anaphylaxis, and in patients with a history or increased risk of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to body weight.

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.

IMPORTANT SAFETY INFORMATION

Epinephrine Injection, USP 0.3 mg and 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.

Epinephrine Injection, USP Auto-Injector 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.

Please see the full Prescribing Information and Patient Information.

References:

1. Epinephrine Injection, USP [prescribing & patient information]. Morgantown, WV: Mylan Specialty L.P.; 2016. 2. Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis—a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015;115(5):341-384. 3. Simons FE. Anaphylaxis. J Allergy Clin Immunol. 2010;125(2)(suppl 2):S161-S181. 4. Volcheck GW. Clinical Allergy: Diagnosis and Management. Rochester, MN: Mayo Foundation for Medical Education and Research; 2009. 5. Food and Drug Administration. FDA List of Authorized Generic Drugs. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm126389.htm. Accessed October 4, 2016. 6. FDA [US Department of Health and Human Services Food and Drug Administration]. Facts About Generic Drugs. Washington, DC: US Department of Health and Human Services.

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IMPORTANT SAFETY INFORMATION

Epinephrine Injection, USP 0.3 mg and 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.

IMPORTANT SAFETY INFORMATION

Epinephrine Injection, USP 0.3 mg and 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.

Epinephrine Injection, USP Auto-Injector 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.

Please see the full Prescribing Information and Patient Information.

INDICATIONS

Epinephrine Injection, USP Auto-Injectors are indicated in the emergency treatment of Type I allergic reactions, including anaphylaxis, to allergens, idiopathic and exercise-induced anaphylaxis, and in patients with a history or increased risk of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to body weight.

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