Dey Launches and Unveils Next-Generation, Needle-Protected EpiPen® (Epinephrine) Auto-Injector with Enhanced Patient-Friendly Features
BASKING RIDGE, N.J., Oct. 26 - Dey, a subsidiary of Mylan (Nasdaq: MYL - News), today launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use.
Dey President Carolyn Myers, Ph.D., said: "We are very pleased to be launching Dey's highly anticipated next-generation, needle-protected EpiPen Auto-Injector. The objective of the product's new features is to give those who carry an epinephrine auto injector some additional peace of mind when it comes to the risk of anaphylaxis. We also hope that those who are at risk of anaphylaxis but currently don't carry an epinephrine auto injector will become as prepared as possible for the risk of allergen exposure."
EpiPen Auto-Injector is the number one prescribed first-line emergency auto-injector for potentially life-threatening allergic reactions known as anaphylaxis. Anaphylaxis can occur when people with allergies to food, insect stings, latex or other allergens come in contact with that allergen. Immediate access to epinephrine is critical during the first few minutes of an anaphylactic reaction.
"Prompt administration of epinephrine during a severe allergic reaction helps save lives so it's important that people not only have immediate access to a self-injected epinephrine but know how to properly use it," said Dr. Phil Lieberman, Clinical Professor of Medicine and Pediatrics, University of Tennessee College of Medicine. "This new EpiPen Auto-Injector offers enhancements to make it easier for people to administer epinephrine quickly and properly in an emergency situation."
The next-generation EpiPen Auto-Injector introduces built-in needle protection, making EpiPen the only epinephrine auto-injector with no exposed needle before and after use. Other benefits of the re-designed EpiPen Auto-Injector include:
An ergonomically-designed, easy-to-grasp oval barrel with illustrated instructions that allow for rapid understanding and proper use of EpiPen Auto-Injector. The oval shape also prevents the device from rolling out of reach during an emergency; one-step flip-top carry case that allows for rapid, single-handed removal; bright orange colors and arrows to help quickly identify the needle end of the device and reduce the risk of accidental thumb puncture.
Importantly, any patient that currently carries or has recently received an EpiPen or EpiPen Jr. Auto-Injector should continue to carry that EpiPen Auto-Injector until their current pen is used or reaches its expiration date. Upon renewal of their next EpiPen Auto-Injector prescription, patients will automatically receive the next generation EpiPen Auto-Injector.
About Anaphylaxis
Anaphylaxis is a severe allergic reaction that involves a number of body systems and can be fatal within minutes, either through swelling that shuts off airways or through a significant drop in blood pressure. Anaphylaxis occurs in people with allergies to certain foods, insect stings, medications, latex or other allergens. As many as 15% of Americans - up to 12 million people - have an allergy that may put them at risk for anaphylaxis. There are up to 2,000 episodes of anaphylaxis per every 100,000 people in the U.S. each year. The precise incidence of anaphylaxis is unknown because this serious, life-threatening condition is believed to be underreported. The vast majority of deaths from anaphylaxis occur in individuals who do not receive epinephrine in time.
About EpiPen Auto-Injector
Indications
EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg 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. EpiPen and EpiPen Jr are intended for immediate self-administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.
As with any medication, EpiPen Auto-Injector has an expiration date printed directly on the unit and shelf carton and should therefore be replaced when the unit expires. The product should be stored at room temperature and never refrigerated or kept where it might be exposed to extreme temperatures, such as in the glove compartment of a car.
Dey, the distributor of EpiPen Auto-Injector, offers patient support through free membership in the EpiPen Center for Anaphylactic Support (CAS) Program(TM). This program provides helpful tips, resources and an expiration reminder program. Information on how to join can be found on the patient insert dispensed with the product and by visiting www.epipen.com.
Important Safety Information
EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTO YOUR VEIN, BUTTOCK, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure and heart disease, 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 doctor 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 take the EpiPen or EpiPen Jr Auto-Injector.
The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.
Talk to your healthcare professional to see if EpiPen or EpiPen Jr Auto-Injector is right for you.
About Dey
Dey, a subsidiary of Mylan (Nasdaq: MYL - News), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, severe allergic reactions and psychiatric disorders. The company puts patients first and facilitates efficient, cost-effective partnerships with customers. For more information, please visit www.dey.com.
About Mylan
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.
EpiPen® is a registered trademark of Dey
See accompanying full prescribing information (PI) or visit www.epipen.com for full PI.