Full AUVI-Q product line available at Walgreens
locations nationwide at no cost to commercially insured patients
and those who are eligible for kaleo’s patient support programs
For patients who are unable to fill their
current epinephrine auto-injector prescription, Walgreens
pharmacists will work with their healthcare providers to determine
if AUVI-Q is right for them
Walgreens and kaléo, a privately-held pharmaceutical company,
today announced AUVI-q® (epinephrine injection, USP) 0.1 mg
auto-injector is available at Walgreens locations nationwide.
AUVI-q 0.1 mg is the first and only epinephrine auto-injector (EAI)
approved by the U.S. Food and Drug Administration (FDA) for infants
and toddlers weighing 16.5 to 33 pounds (7.5 to 15 kilograms).
Through this collaboration, Walgreens is the first national retail
pharmacy to offer the entire AUVI-Q auto-injector product line,
which also includes AUVI-Q 0.3 mg and 0.15 mg doses.
An estimated 7.6 percent of U.S. children aged 17 years or
younger were found to have a food-specific allergy based on survey
data from 38,408 children. The same study also found that 42.3
percent of children with a food allergy have a history of at least
one severe food allergic reaction.1
“With the addition of an AUVI-q auto-injector for infants and
toddlers at Walgreens pharmacies nationwide, we can help ensure
families and children facing life-threatening allergies have
convenient and affordable access to the medicines they need,” said
Rina Shah, PharmD, group vice president of specialty and retail
pharmacy at Walgreens. “Expanding our agreement with kaléo is one
more way that Walgreens is helping lower costs for patients,
increasing accessibility to care and creating a seamless experience
for our customers and patients.”
All eligible patients with commercial insurance, even those with
high-deductible plans, can obtain AUVI-Q at no cost. For eligible
patients who do not have insurance or prescription drug coverage,
kaléo may be able to support through the kaléo Cares Patient
Assistance Program. Please see additional information on patient
eligibility and the terms and conditions at
www.auvi-q.com/get-auvi-q/.
As supply issues related to epinephrine auto-injector products
by other manufacturers continue, the collaboration aims to broaden
access to an available treatment option for patients with
life-threatening allergies, especially as families prepare for
back-to-school season.
“With approximately one in 13 children in the U.S. living with
life-threatening food allergies2, it is critically important that
parents and caregivers be able to access an epinephrine
auto-injector,” said Phil Rackliffe, general manager of Allergy and
Pediatrics at kaléo. “Families can get AUVI-Q 0.3 mg, 0.15 mg, and
now, 0.1 mg, with a prescription, on-site at Walgreens locations
nationwide.”
AUVI-Q features a voice instruction system that helps guide
users step-by-step through the injection process, as well as a
needle that automatically retracts following administration. It is
about the size of a credit card and thickness of a cell phone, and
fits in most pockets. AUVI-Q is available in three doses - AUVI-Q
0.3 mg for those weighing 66 pounds (30 kilograms) or more, AUVI-Q
0.15 mg for children weighing between 33 and 66 pounds (15 to 30
kilograms) and AUVI-q 0.1 mg for infants and toddlers 16.3 to 33
pounds (7.5 to 15 kilograms).
AUVI-Q is a prescription medicine approved by the FDA to treat
life-threatening allergic reactions, including anaphylaxis, in
people who are at risk for or have a history of serious allergic
reactions. Anaphylaxis is a serious allergic reaction that can
happen quickly and may cause death2. Anaphylaxis can occur from
exposure to allergens including tree nuts, peanuts, milk, eggs,
fish, shellfish, soy, wheat, insect bites, latex and medication,
among other allergens3-7. AUVI-Q does not take the place of
emergency medical care. Patients need to seek immediate medical
treatment after using AUVI-Q.
To learn more about AUVI-Q, please visit www.auvi-q.com.
References
- S. Gupta, R. et al. The Public Health Impact of Parent-Reported
Childhood Food Allergies in the United States. Pediatrics (2018).
142. e20181235. 10.1542/peds.2018-1235.
- Lieberman, P. (2015). Anaphylaxis After Cystoscopy. The Journal
of Allergy and Clinical Immunology: In Practice, 3(3), 469-470.
doi:10.1016/j.jaip.2014.05.007
- Gupta RS, Warren CM, Smith BM, et al. Prevalence and severity
of food allergies among US adults. JAMA Netw Open. 2019 Jan
4;2(1):e185630.
- McWilliam V, Koplin J, Lodge C, Tang M, Dharmage S, Allen K.
The prevalence of tree nut allergy: a systematic review. Curr
Allergy Asthma Rep. 2015 Sep;15(9):54.
- Lopes JP, Kattan J, Doppelt A, Nowak-Wegrzyn A, Bunyavanich S.
Not so sweet: true chocolate and cocoa allergy. J Allergy Clin
Immunol Pract. 2019 Apr 26. pii: S2213-2198(19)30396-4.
- Golden D. Stinging insect allergy. Am Fam Physician.
2003;67(12):2541-2546.
- Kelly K, Kurup V, Reijula K. The diagnosis of natural rubber
latex allergy. J Allergy Clin Immunol. 1994;93(5):813-816.
Indication
AUVI-Q® (epinephrine injection, USP) is a prescription medicine
used to treat allergic reactions, including anaphylaxis, in people
who are at risk for or have a history of serious allergic
reactions.
Important Safety Information
AUVI-Q is for immediate self (or caregiver) administration and
does not take the place of emergency medical care. Seek immediate
medical treatment after using AUVI-Q. Each AUVI-Q contains a single
dose of epinephrine. AUVI-Q should only be injected into your
outer thigh, through clothing if necessary. If you inject a
young child or infant with AUVI-Q, hold their leg firmly in place
before and during the injection to prevent injuries. Do not inject
AUVI-Q into any other part of your body, such as into veins,
buttocks, fingers, toes, hands, or feet. If this occurs, seek
immediate medical treatment and make sure to inform the healthcare
provider of the location of the accidental injection. Only a
healthcare provider should give additional doses of epinephrine if
more than two doses are necessary for a single allergic
emergency.
Rarely, patients who use AUVI-Q may develop infections at the
injection site within a few days of an injection. Some of these
infections can be serious. Call your healthcare provider right away
if you have any of the following symptoms at an injection site:
redness that does not go away, swelling, tenderness, or the area
feels warm to the touch.
If you have certain medical conditions, or take certain
medicines, your condition may get worse or you may have more or
longer lasting side effects when you use AUVI-Q. Be sure to
tell your healthcare provider about all the medicines you take,
especially medicines for asthma. Also tell your healthcare provider
about all of your medical conditions, especially if you have
asthma, a history of depression, thyroid problems, Parkinson’s
disease, diabetes, heart problems or high blood pressure, have any
other medical conditions, are pregnant or plan to become pregnant,
or are breastfeeding or plan to breastfeed. Epinephrine should be
used with caution if you have heart disease or are taking certain
medicines that can cause heart-related (cardiac) symptoms.
Common side effects include fast, irregular or ‘pounding’
heartbeat, sweating, shakiness, headache, paleness, feelings of
over excitement, nervousness, or anxiety, weakness, dizziness,
nausea and vomiting, or breathing problems. These side effects
usually go away quickly, especially if you rest. Tell your
healthcare provider if you have any side effect that bothers you or
that does not go away.
Please see the full Prescribing Information and the Patient
Information at www.auvi-q.com.
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.
About Walgreens
Walgreens (walgreens.com), one of the nation's largest drugstore
chains, is included in the Retail Pharmacy USA Division of
Walgreens Boots Alliance, Inc. (NASDAQ: WBA), the first global
pharmacy-led, health and wellbeing enterprise. Approximately 8
million customers interact with Walgreens in stores and online each
day, using the most convenient, multichannel access to consumer
goods and services and trusted, cost-effective pharmacy, health and
wellness services and advice. As of June 28, 2018, Walgreens
operates approximately 9,800 drugstores with a presence in all 50
states, the District of Columbia, Puerto Rico and the U.S. Virgin
Islands, along with its omnichannel business, Walgreens.com.
Approximately 400 Walgreens stores offer Healthcare Clinic or other
provider retail clinic services.
About kaléo (kuh-LAY-oh)
Kaléo is a new type of pharmaceutical company, dedicated to
building innovative solutions for serious and life-threatening
medical conditions. We believe patients and caregivers are the
experts on how their medical condition impacts their lives and are
an integral part of our product development process. Kaléo is a
privately-held company headquartered in Richmond, Virginia. For
more information, visit www.kaleo.com.
About AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)
AUVI-Q (epinephrine injection, USP) Auto-injector is a
prescription medicine used to treat emergency allergic reactions,
including anaphylaxis, in people who are at risk for or who have a
history of serious allergic reactions. AUVI-Q contains epinephrine,
a first-line treatment for allergic reactions that occur as a
result of exposure to allergens including food such as peanuts,
tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect
stings or bites; latex and medication, among other allergens and
causes.
AUVI-Q is the only compact epinephrine auto-injector with a
voice instruction system that helps guide patients and caregivers
step-by-step through the injection process, and a needle that
automatically retracts following administration. In anaphylaxis
emergencies, it is often individuals without medical training who
need to step in and deliver potentially life-saving epinephrine.
AUVI-Q was designed through careful analysis of the situations
where epinephrine auto-injectors are used and with significant
input from the allergy community that relies on it incorporating
Human Factors Engineering (HFE). HFE is about designing products or
systems that are easy to operate and, most importantly, support
correct use, with the goal to remove the potential for error. For
more information about AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg) visit
www.auvi-q.com.
Forward-Looking Statements
All statements in this release that are not historical are
forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are not guarantees of future
performance and involve risks, assumptions and uncertainties,
including, but not limited to, those related to the timing and
effectiveness of collaboration plans, the ability to realize the
anticipated benefits of the collaboration, competitive actions in
the marketplace, and the ability to achieve anticipated financial
and operating results in the amounts and at the times anticipated,
as well as those described in Item 1A (Risk Factors) of Walgreens
Boots Alliance, Inc.’s Form 10-K for its fiscal year ended August
31, 2018 and Form 10-Q for its fiscal quarter ended February 28,
2019, Bausch Health’s Form 10-K for its fiscal year ended December
31, 2018, and subsequent documents that Walgreens Boots Alliance,
Inc. and Bausch Health file or furnish with the Securities and
Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially. These
forward-looking statements speak only as of the date they are made.
Except to the extent required by law, each of Walgreens Boots
Alliance, Inc., Walgreens and Bausch Health do not undertake, and
expressly disclaim, any duty or obligation to update publicly any
forward-looking statement after the date of this release, whether
as a result of new information, future events, changes in
assumptions or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20190711005068/en/
Walgreens Contact: Rebekah Pajak 224-214-8179
rebekah.pajak@walgreens.com Kaléo Contact: Caryn Foster
Durham (804)-521-7815 caryn.durham@kaleo.com
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