Mylan Confirms Availability of EpiPen® (epinephrine injection) Auto-Injector for U.S. Patients Affected by Sanofi’s Auvi-Q® (epinephrine injection, USP) Recall

HERTFORDSHIRE, England and PITTSBURGH, Oct. 29, 2015 /PRNewswire/ — Mylan Specialty, a division of Mylan N.V. (Nasdaq: MYL[1]) which markets and distributes EpiPen® (epinephrine injection) Auto-Injector, today commented on the voluntary nationwide recall of Sanofi’s Auvi-Q® (epinephrine injection, USP) auto-injector. Mylan confirms that EpiPen® and EpiPen Jr® (epinephrine injection) Auto-Injectors are not affected by the Auvi-Q® recall, and the company has sufficient supply of EpiPen® Auto-Injector to meet any anticipated demand.

Yesterday, Sanofi announced the recall of all Auvi-Q® auto-injectors currently on the market, including the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. According to Sanofi, Auvi-Q® products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences. Given the life-threatening nature of anaphylaxis, those affected by the recall are encouraged to contact their healthcare provider as soon as possible to obtain a prescription for EpiPen® Auto-Injector. According to Sanofi, any out of pocket costs incurred for a new epinephrine auto-injector will be reimbursed. Additional information related to the Auvi-Q® recall can be found on or by calling 1-866-726-6340 or emailing [email protected][2].

“We are confident that the widespread familiarity with EpiPen® Auto-Injector established over more than 25 years, coupled with our robust training resources, will provide access and support for those impacted by the Auvi-Q® recall. Anaphylaxis is unpredictable, and should an emergency occur, patient preparedness and immediate access to reliable treatment is critical. Mylan continues to be committed to help ensure access to epinephrine, the first-line treatment for anaphylaxis, and is working to provide a seamless transition for patients and their caregivers who may now be prescribed EpiPen® Auto-Injector,” said Mylan CEO, Heather Bresch.

Training and support have been a primary focus since the launch of EpiPen® Auto-Injector. Epinephrine auto-injector devices look and function differently, so it is important that patients receive training on proper administration of a prescribed epinephrine auto-injector in a physician’s office and practice between doctor office visits. EpiPen® Auto-Injector features include a flip-top carry case designed for single-handed opening and a never-see-needle design that offers needle protection before and after use. Each EpiPen 2-Pak® and EpiPen Jr 2-Pak® includes a needle-free, medication-free Trainer to practice administration technique.

Additional training resources available for patients and caregivers include:

Additionally, Mylan offers several patient programs and resources including the “$0 Co-Pay Offer” for eligible patients* and a patient assistance program for qualified individuals. Patients can download the co-pay card at[3].

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[4].

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit[5] or call 1-800-FDA-1088.

For additional information, please contact us at 800-395-3376.

*The CO-PAY card can reduce the amount of your out-of-pocket expense up to a maximum of $100 per two-pack of EpiPen® (epinephrine injection) Auto-Injector carton, up to a maximum of 3 two-packs per prescription, until 12/31/15. Valid prescription with Prescriber ID# required.

The CO-PAY card can be redeemed only by patients or patient guardians who are 18 years of age or older who are a resident of the United States. Not valid for cash paying patients (except for privately insured patients without coverage for EpiPen® Auto-Injector who make full cash payment) and patients who are covered by any state or federally funded healthcare program, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare. Void outside the U.S. and its territories or where prohibited by law, taxed, or restricted.

The card is not health insurance. Mylan Specialty reserves the right to amend or end this program at any time without notice.

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