POTTERS BAR, ENGLAND, AND PITTSBURGH – May 7, 2015 – Mylan N.V. (Nasdaq: MYL), a leading global pharmaceutical company, today announced the launch of EpiPen® On Location™. This campaign is a national call-to-action to help those living with potentially life-threatening (severe) allergies and their caregivers understand the importance of being prepared for a life-threatening allergic reaction (anaphylaxis) by avoiding allergic triggers and having access to two epinephrine auto-injectors, such as EpiPen® (epinephrine injection) Auto-Injectors, at all times — whether at home, school, work or on vacation. Studies reveal that nearly half of all anaphylactic episodes happen outside of the home, increasing the importance of having epinephrine in multiple locations. Epinephrine is the only first-line treatment for anaphylaxis.
To help spread the word, three On Location Ambassadors are sharing their personal stories about managing food allergies for the first time during National Asthma and Allergy Awareness Month. Each of the Ambassadors lives with, or cares for someone with, food allergies. Captured on camera, "Project Runway" judge and Creative Director of Marie Claire Nina Garcia, Chef and cooking competition judge Amanda Freitag and "Girl Meets World" actor Auggie Maturo and his parents, discuss why it is important to be prepared should anaphylaxis occur.
"As a working mom in the high-paced fashion industry, I feel like my daily to-do list is a mile long, but without a doubt, the most important item on that list is ensuring my son avoids his allergic triggers and always has access to two EpiPen Jr® (epinephrine injection) Auto-Injectors in several locations including at home, at school and on vacation," said Garcia, whose 8-year-old son was diagnosed with food allergies to peanuts and tree nuts as a young child and has experienced anaphylaxis. "Though I do everything I can to help my son, I've seen firsthand that life happens, so we've got to be prepared."
Garcia, Freitag and the Maturos are asking people to visit EpiPenOnLocation.com to watch their videos and share them with friends and family using #OnLocationTips and #promo. With different life experiences they each have learned the importance of incorporating their anaphylaxis action plan into their daily lives. Families managing known severe allergies are encouraged to follow their own anaphylaxis action plan, which should include 1) avoiding allergic triggers, 2) recognizing the signs and symptoms of anaphylaxis, 3) having access to two epinephrine auto-injectors, such as EpiPen® Auto-Injectors, at all times and 4) seeking immediate emergency medical care should anaphylaxis occur.
Participants who share the EpiPen® On Location videos from May 7 – July 9, 2015 will be entered into a Mylan-sponsored sweepstakes for a chance to win one of three, three-night/four-day Walt Disney World Resort vacations for four to be taken during the 2015 Epcot International Food & Wine Festival, which runs between Sept. 25 – Nov. 16, 2015. Up to three shares per week will be considered toward a chance to win. The grand prize packages include a resort stay, theme park tickets, a vacation travel kit prepared by Nina Garcia and more. Plus, if winners travel between Oct. 2 and 4, 2015, they will also have an opportunity to attend culinary demonstrations and educational seminars featuring Chef Freitag and Auggie Maturo and his family. The sweepstakes will run through July 9, 2015. For the official sweepstakes rules, visitwww.epipen.com/EOLTC.
Mylan and Walt Disney Parks & Resorts are committed to supporting guests with severe allergies. The companies formed an alliance in late 2014 to increase awareness of anaphylaxis and enhance access to epinephrine.
"Anaphylaxis is unpredictable, and one reaction does not predict the next. Those at increased risk should avoid their allergic triggers, have access to two epinephrine auto-injectors everywhere they go and know how to use them immediately, if needed," said Maeve O'Connor, MD, FACAAI, FAAAAI, FACP, Allergy, Asthma and Immunology Relief of Charlotte, N.C. "When it comes to anaphylaxis, the time to think about being prepared is before it happens so that you are immediately ready to respond; this is what the EpiPen® On Location program is all about."
Nina Garcia, Amanda Freitag, Auggie Maturo and his parents and Dr. Maeve O'Connor are paid spokespeople of Mylan.
Anaphylaxis is a life-threatening allergic reaction that has many possible triggers, occurs quickly, without warning, and must be treated immediately with epinephrine. Symptoms may include hives, itching, swelling or redness of the skin, tightness in the throat, nausea, dizziness, breathing problems, a decrease in blood pressure and/or fainting. Anaphylaxis can be caused by triggers, such as food, stinging and biting insects, medicines, latex or even exercise. While symptoms of an allergic reaction vary from person to person, reactions can quickly progress to become life-threatening.
An epinephrine auto-injector, such as EpiPen® (epinephrine injection) Auto-Injector, should be given at the first sign of anaphylaxis, followed by seeking immediate emergency medical care. Delays in epinephrine administration have been associated with negative health consequences, even possibly death.
EpiPen® Auto-Injector is approved for the emergency treatment of life-threatening allergic reactions (anaphylaxis) and for people who are at increased risk for anaphylaxis. Antihistamines, such as Benadryl®, are not approved for these uses and should not be substituted for epinephrine. Despite these facts, the use of antihistamines is the most common reason reported for not using epinephrine and may place a patient at significantly increased risk for progression toward a life-threatening allergic reaction. In addition, the use of certain antihistamines can increase the effects of epinephrine, so talk to your doctor before using antihistamines with EpiPen® Auto-Injector.
EpiPen® (epinephrine injection) 0.3 mg and EpiPen Jr® (epinephrine injection) 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 administration as emergency supportive therapy only. Seek immediate emergency medical help right away.
Important Safety Information
EpiPen® and EpiPen Jr® Auto-Injectors contain a single dose of epinephrine, which you (or your caregiver or others who may be in a position to administer EpiPen® or EpiPen Jr®) inject into the middle of your outer thigh (upper leg) (through clothing, if necessary). Get emergency medical help right away. You may need further medical attention. Only a health care professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. DO NOT INJECT INTO YOUR VEINS, BUTTOCKS, 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 or 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 use EpiPen® or EpiPen Jr®.
The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea or vomiting, difficulty breathing, paleness, dizziness, weakness, shakiness, headache, apprehension, nervousness or anxiety. These side effects may go away if you rest. Tell your health care 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.
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.
About EpiPen® (epinephrine injection) Auto-Injector
EpiPen® (epinephrine injection) and EpiPen Jr® (epinephrine injection) Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions. Each EpiPen 2-Pak® and EpiPen Jr 2-Pak® contains two single auto-injectors, instructions for use and an EpiPen®Trainer, with no drug or needle, to help patients become familiar with the administration technique. EpiPen® Auto-Injector should be administered immediately at the first sign of an anaphylactic reaction. EpiPen® Auto-Injector is not a substitute for emergency medical treatment. Patients should seek emergency medical attention immediately following administration. EpiPen® Auto-Injector has been the No. 1 prescribed epinephrine auto-injector in the U.S. for more than 25 years and has a simple, three-step administration process. For more information about EpiPen® Auto-Injector, please visit www.EpiPen.com.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
EpiPen®, EpiPen Jr®, EpiPen 2-Pak® and EpiPen Jr 2-Pak® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned subsidiary, Mylan Specialty L.P. ON LOCATION™ is a trademark of Mylan Inc. Walt Disney World® Resort and Epcot® International Food & Wine Festival are registered trademarks of Disney. All other trademarks are the property of their respective owners.