Dear Healthcare Professional,
We are writing to help ensure you are aware of important information related to the epinephrine autoinjector market.
On October 28, 2015, Sanofi announced a voluntary nationwide recall of Auvi-Q® (epinephrine injection,
USP) devices in the U.S. Auvi-Q® is indicated to treat life-threatening allergic reactions, or anaphylaxis, in
people who are at risk for or have a history of these reactions. EpiPen® (epinephrine injection) Auto-
Injector and EpiPen Jr® (epinephrine injection) Auto-Injector supply are not affected by the recall.
Both products are currently available for the emergency treatment of life-threatening allergic reactions and
for people who are at increased risk for these reactions.
The recall involves all Auvi-Q® currently on the market and includes both the 0.15 mg and 0.3 mg strengths
for hospitals, retailers and consumers.
Per the Sanofi recall notification, customers with questions regarding this recall can go to www.Auvi-Q.com
and call [1-866-726-6340] Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return
their Auvi-Q® devices. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for
out of pocket costs incurred for the purchase of new epinephrine auto injectors with proof of purchase.
Patient safety is our primary concern. We are working to help ensure a seamless transition for at-risk
patients in need of new epinephrine auto-injectors. EpiPen® Auto-Injector has been the number one
prescribed epinephrine auto-injector in the U.S. for more than 25 years and has three-step, simple-to-follow
instructions for use. We offer patient programs and resources, including our “$0 Co-Pay Offer” for eligible
patients* and patient assistance program for qualified individuals. See full terms and conditions for the copay
offer at EpiPenSavings.com.
Given the life-threatening nature of anaphylaxis, we recommend that all patients receive training on proper
administration for EpiPen® Auto-Injector in a physician’s office, and practice between doctor office visits to
help ensure preparedness should a life-threatening allergic reaction occur. It’s critical that users understand
how to quickly and properly administer the product in an emergency.
Training and support have been a primary focus since the launch of EpiPen® Auto-Injector. 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:
A “How To” video that is available on epipen.com, our YouTube® Channel and through the My EpiPlan®
app.
The Anaphylaxis: Know It. See It. Treat It. Training Video for school staff which is available on DVD or
for download at EpiPen4Schools.com.
Additional EpiPen® Trainers may be ordered on epipen.com.
If you have questions regarding Auvi-Q® or the recall, please contact Sanofi directly at: 1-866-726-6340 or
email cs@sanofi.com.
Indications
EpiPen® (epinephrine injection) 0.3 mg and EpiPen Jr® (epinephrine injection) 0.15 mg Auto-Injectors are
indicated in the emergency treatment of type 1 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.
Important Safety Information
EpiPen® and EpiPen Jr® Auto-Injectors should only be injected into the anterolateral aspect of the thigh. Do
not inject intravenously, into buttock, or into digits, hands, or feet. Epinephrine should be used with
caution in patients with certain heart diseases, 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 in patients with
underlying cardiac disease or taking cardiac glycosides or diuretics.
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. Other adverse reactions
include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations,
pallor, nausea and vomiting, headache, and/or respiratory difficulties.
EpiPen® and EpiPen Jr® 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.
Please see accompanying 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.
Thank you for your attention to this important information, and please don’t hesitate to reach out with any
questions.
Best,
Frank Casty, MD FACP
Head Global Medical Affairs
*This 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.
This 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.
This card is not health insurance. Mylan Specialty reserves the right to amend or end this program at any
time without notice.
EpiPen®, EpiPen Jr® , EpiPen 2-Pak®, EpiPen Jr 2-Pak® and My EpiPlan® are registered trademarks owned
by the Mylan companies. All other trademarks are property of their respective owners.
© 2015 Mylan Specialty L.P. All rights reserved.
EPI-2015-0904