Transcript (epinephrine) Auto-Injectors

~1 in 13
Children in the United States
suffers from food allergies
Gupta RS et al. Pediatrics. 2011;128(1):e9-e17.
Food-Induced Anaphylaxis Gains National Media Attention
Study: Food Allergies More Common,
More Severe Among Children
Girl's death highlights allergy safety
in schools
CNN - January 11, 2012
CNN - June 20, 2011
Finding Food Allergy Allies; Schools,
States, Restaurants Take Steps;
Beyond the Peanut-Free Table
New Law Hopes To Help Schools Adapt To
Deadly Food Allergies
The Wall Street Journal - February 27, 2012
KSHB 41 (NBC affiliate) Kansas City, MO - February 28, 2012
Food Allergies Can be Deadly
The Atlanta Journal-Constitution - August 22, 2011
It is Time for National Education
of Life-Threatening Allergic
Reactions
The Huffington Post - October 4, 2011
Survey: Many Restaurant
Workers Don't Understand
Food Allergies
Time - April 15, 2011
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
2
The Role of EpiPen® (epinephrine) and EpiPen Jr®
(epinephrine) Auto-Injectors for Patients
at Risk for Anaphylaxis
Mylan® and the Mylan logo are registered trademarks of Mylan.
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.
© 2012 Mylan Specialty L.P. All rights reserved.
EPI12-5001A/EPI458303-01
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
3
Objectives
• Review the epidemiology of anaphylaxis
• Identify patients who may be at risk for anaphylaxis
• Recognize and communicate the signs and symptoms of
anaphylaxis to patients and caregivers
• Evaluate evidence-based management strategies for
anaphylaxis, with a focus on allergen avoidance and the
development of a comprehensive Anaphylaxis Action Plan
– Communicate key points from the NIAID Food Allergy
Guidelines
– Review the components of an Anaphylaxis Action Plan to help
with preparedness
– Discuss the role of EpiPen® Auto-Injector for the management
of anaphylaxis
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
4
Importance of Allergen Avoidance and
Having a Comprehensive Anaphylaxis Action Plan
•
It is critical to educate patients at risk for anaphylaxis on the importance of
constant allergen avoidance, and to work with them on developing a
comprehensive anaphylaxis action plan1
– Carrying EpiPen® Auto-Injector does not prevent patients from having an
anaphylactic reaction; hence, patients must remain vigilant of their environment
at all times1-3
•
Anaphylaxis Action Plans are essential for emergency preparedness
in the community3
Components of an Anaphylaxis Action Plan should include the following:
•Avoid known allergens whenever possible1-3
•Recognize the symptoms4
•Always carry two EpiPen® Auto-Injectors1,2
•If experiencing anaphylaxis, use an EpiPen® Auto-Injector and seek immediate
emergency medical attention/call 9115
1. Boyce JA et a. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 2. Burks AW et al. J Allergy Clin Immunol. 2012;129(4):906-920; 3. Lieberman P et al. J Allergy Clin
Immunol. 2010;126(3):477-480; 4. Simons FE et al. J Allergy Clin Immunol. 2011;127(3):587-593; 5. EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
5
Patient Case: Nick
• 12-year-old previously diagnosed with mild
asthma; currently taking albuterol inhaler
• Recently experienced abdominal pain and
hives after eating out with friends
(first allergic reaction; no prior history)
• He went out to breakfast and consumed
eggs, wheat toast, and fruit
NOTE: Not a real patient. This is a patient case
study for illustrative purposes only. Not all
patients who experience anaphylaxis will
exhibit these symptoms or results.
• He describes his symptoms as “mild”
• Upon returning home, his mother gave
him an antihistamine and it "took care of
the problem"
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
What is anaphylaxis?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
7
Defining Anaphylaxis
Often occurs
in the community setting3,4
Anaphylaxis is a
severe systemic
allergic reaction that
is rapid in onset and
can cause death1,2
Poses serious consequences for
at-risk patients1
Patients at risk for anaphylaxis
should have a long-term allergy
management plan1
1. Simons FE. J Allergy Clin Immunol. 2009;124(4):625-636; 2. Sampson HA et al. J Allergy Clin Immunol. 2006;117(2):391-397; 3. Simons FE.
J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181; 4. Sicherer SH et al. J Allergy Clin Immunol. 2005;115(3):575-583.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
8
Epidemiology of Anaphylaxis
• Data on anaphylaxis incidence and prevalence are sparse and
often imprecise1
• Lack of a consistent definition for anaphylaxis has hindered any
large-scale evaluation of the national incidence and prevalence
of anaphylaxis2
• There are ~1500 deaths from anaphylaxis annually2
1. Lieberman P et al; the American College of Allergy, Asthma and Immunology Epidemiology of Anaphylaxis Working Group. Ann Allergy Asthma
Immunol. 2006;97(5):596-602; 2. Matasar MJ et al. Curr Allergy Asthma Rep. 2003;3(1):30-35.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
9
Food Is the Most Common Trigger of Anaphylaxis
in Children
• The foods that most commonly trigger anaphylaxis in children include1,2:
– Peanuts, tree nuts (i.e., walnuts, pecans, and others), milk, egg, fish,
and shellfish
• Several national health surveys indicate that food allergy prevalence is on
the rise, especially in children3
– The prevalence of food allergies among children in the United States
increased by 18% from 1997 to 20073
– An increase in food allergies may coincide with an increased incidence of
anaphylaxis4
• Recent data estimate approximately 1 in 13 (8%) overall prevalence of
food allergy among children in the United States4
– Variation in study design and food allergy definition have made it difficult to
establish the actual prevalence of food allergies1
1. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 2. Lieberman P et al. J Allergy Clin Immunol.
2010;126:477-48; 3. Branum AM et al. Pediatrics. 2009;124(6):1549-1555; 4. Gupta RS et al. Pediatrics. 2011;128(1):e9-e17.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
10
Food Allergies and Related Conditions in Children
• Children with food allergies are 2 to 4 times more likely to have
other related conditions, including1:
– Asthma (29%)
– Respiratory allergy (>30%)
– Eczema or skin allergy (~27%)
• Asthma has been identified as a comorbidity in nearly all
food-induced anaphylaxis fatalities2
1. Branum AM, Lukacs SL. NCHS Data Brief (No. 10); October 2008;1-7;
2. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
11
Other Triggers of Anaphylaxis
Insect venom,
medications, and latex1,2
Exercise3
Idiopathic Anaphylaxis4
?
1. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 2. Lieberman P et al; Joint Task Force on Practice Parameters. J Allergy
Clin Immunol. 2005; 115 (3 Suppl 2):S483-S523; 3. Lieberman P et al. J Allergy Clin Immunol. 2010;126:477-480;
4. Pumphrey RSH. Clinical and Experimental Allergy. 2000;30:1144-1150.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
12
What signs and symptoms may be
associated with anaphylactic
reactions?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
13
Common Signs and Symptoms of Anaphylaxis
Airway*
• 70% of episodes1
Central nervous system
• 10%-15% of episodes1
• Larynx: pruritus and
tightness in throat;
dysphonia and hoarseness2
• Uneasiness, throbbing
headache, dizziness,
confusion, tunnel vision2
• Lung: dyspnea,
chest tightness,
wheezing/bronchospasm2
Cardiovascular system*
• 10%- 45% of episodes1
Skin
• 80%- 90% of episodes1
• Chest pain, hypotension,
tachycardia, weak pulse,
dizziness, fainting2
• Urticaria, pruritus, flushing2
• Mucosal tissue: pruritus and
swelling of lips, tongue,
uvula/palate2
Gastrointestinal tract
• 30%- 45% of episodes1
• Nausea, cramping, abdominal
pain, vomiting, diarrhea2
*Potentially life-threatening symptoms.3
1. Simons FE. J Allergy Clin Immunol. 2009;124(4):625-636; 2. Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181; 3. Simons FE.
J Allergy Clin Immunol. 2006;117(2):367-377.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
14
What criteria are used to clinically
diagnose anaphylaxis?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
15
When Is It Anaphylaxis? (Sampson Criteria)
• Anaphylaxis is highly likely when any 1 of the 3 criteria below is fulfilled1
CRITERION 1:
Unknown allergen exposure
CRITERION 2:
Likely allergen exposure
(2 or more of the following)
Involvement of the skin
and/or mucosal tissue,
and
(a) respiratory compromise
or
(b) reduced blood pressure
• Involvement of the
skin-mucosal tissue
CRITERION 3:
Known allergen exposure
• Reduced blood pressure
• Respiratory compromise
• Reduced blood pressure
• Persistent GI symptoms
• CV symptoms and respiratory distress are not mandatory for a diagnosis of anaphylaxis2
GI=gastrointestinal; CV=cardiovascular.
NOTE: Anaphylactic signs and symptoms associated with each criterion are assumed to be acute in nature
(occurring within minutes to several hours upon exposure).
1. Sampson HA et al. J Allergy Clin Immunol. 2006;117(2):391-397; 2. Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
16
Likelihood of Occurrence
The Continuum of Anaphylaxis
Allergen
exposure 1
Biphasic reaction (~20% of cases4)
Initial Reaction
Anaphylaxis
signs & symptoms
(minutes to hours)1,2,*
5m 10m 15m 20m 25m 30m
Signs & symptoms
occur within 1-72 hours
(typically 8 hours)4
1h 2h 3h 4h 5h 6h 7h 8h 9h 10h
72h
Time
Anaphylaxis signs and symptoms may include3
• Swelling of the tongue, lips, eyes, or palate
• Coughing, wheezing, or tightness of the chest
• Hypotension, dizziness, or fainting
• Nausea, vomiting, or abdominal pain
• Itching, hives, rash, or flushing
Biphasic reaction:
• Symptoms recur after initial symptoms have subsided,
despite no further trigger exposure4
• There are no reliable predictors for occurence2
• Despite therapy, some patients experience
biphasic or protracted reactions5
• The severity of an initial reaction does not predict the severity of future reactions3
* Average time to symptom onset can vary depending on the allergen.4
1. Sampson HA et al. J Allergy Clin Immunol. 2006;117(2):391-397; 2. Lieberman P et al. J Allergy Clin Immunol. 2010;126:477-480; 3. Boyce JA et al;
NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 4. Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181;
5. Ellis AK et al. CMAJ. 2003;169(4):307-312.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
17
What do current guidelines recommend
as first-line treatment for anaphylaxis?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
18
Guidelines Recommend Epinephrine as the Only
First-Line Treatment of Anaphylaxis*
WAO Anaphylaxis
Guidelines1
• Epinephrine has a
primary role in the
management of
anaphylaxis
• Prompt intramuscular
injection of epinephrine,
the first-line medication,*
should not be delayed by
taking the time to draw
up and administer
adjunctive medications,
such as antihistamines
and glucocorticoids
Anaphylaxis Practice
Parameter2
• Epinephrine is the
drug of choice for the
treatment of
anaphylaxis
• The appropriate dose
of epinephrine should
be given promptly at
the onset of apparent
anaphylaxis
NIAID-Sponsored
Expert Panel
on Food Allergy3
• Epinephrine is the firstline treatment* in all
cases of anaphylaxis
• When there is
suboptimal response to
the initial dose of
epinephrine, or if
symptoms progress,
repeat epinephrine
dosing remains first-line
therapy* over adjunctive
treatments
• Upon discharge, 2 doses
of epinephrine autoinjector should be
prescribed
ICON: Food
Allergy4
• Epinephrine is the
first-line treatment*
for anaphylaxis
• Upon discharge,
2 doses of
epinephrine autoinjector should be
prescribed
• Patients must be
educated on when
and how to use the
epinephrine autoinjector device
* If
experiencing anaphylaxis, use an EpiPen® Auto-Injector and seek immediate emergency medical attention/call 911.5
ICON=International Consensus; NIAID=National Institute of Allergy and Infectious Diseases; WAO=World Allergy Organization.
1. Simons FE et al. J Allergy Clin Immunol. 2011;127(3):587-593; 2. Lieberman P et al. J Allergy Clin Immunol. 2010;126(3):477-480.e1-e42; 3. Boyce JA et
al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 4. Burks AW et al. ICON: food allergy. J Allergy Clin Immunol.
2012;129(4):906-920; 5. EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
19
Pharmacologic Effects of Epinephrine
Epinephrine’s α1- and b2-adrenergic effects help alleviate the
life-threatening symptoms of anaphylaxis in most organ systems
Epinephrine
β2-receptor
α1-receptor
Vasoconstriction
BP
Relieves
hypotension and shock
Additional pharmacologic effects: at β1-receptor:
Mucosal edema (larynx)
BD
Relieves upper airway
obstruction
Wheezing
heart rate;
cardiac contraction force.
BP=blood pressure; BD=bronchodilation.
Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
20
Mediator release
Hives
Likelihood of Occurrence
Use Epinephrine Auto-Injector Promptly at the First
Signs and Symptoms of Anaphylaxis
Allergen
exposure1
Biphasic reaction (~20% of cases4)
Initial Reaction
Signs & symptoms
occur within 1-72 hours
(typically 8 hours)4
Anaphylaxis
signs & symptoms
(minutes to hours)1,2,*
5m 10m 15m 20m 25m 30m
1h 2h 3h 4h 5h 6h 7h 8h 9h 10h
72h
Time
• Use epinephrine auto-injector promptly2-4
‒ Delayed epinephrine injection may increase the
risk of life threatening outcomes4
‒ Symptoms not immediately life-threatening may
progress rapidly2,3
•
• ~20% of cases may warrant a second
dose of epinephrine4
• Benefits of epinephrine far outweigh
the risks of unnecessary dosing2
There are no absolute contraindications to the use of epinephrine in a life-threatening situation3
* Average time to symptom onset can vary depending on the allergen.4
1. Sampson HA et al. J Allergy Clin Immunol. 2006;117(2):391-397; 2. Lieberman P et al. J Allergy Clin Immunol. 2010;126:477-480; 3. Boyce JA et al; NIAID-Sponsored
Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 4. Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
21
Antihistamines Are Recommended
as Adjunctive Therapy for Anaphylaxis
• Antihistamines as adjunctive therapy for anaphylaxis
– H1-antihistamines relieve itch and hives but do not prevent
or relieve life-threatening symptoms of anaphylaxis,
including upper or lower airway obstruction, and shock
“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 reaction.”
— NIAID-Sponsored Expert Panel
Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
22
What factors may increase the risk
for anaphylaxis?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
23
Who May Be At Risk? Screening Children for Food Allergies
• The NIAID-Sponsored Expert Panel on Food Allergy suggests that children <5
years old with moderate to severe atopic dermatitis (AD) be considered for
evaluation for allergies to milk, egg, peanut, wheat, and soy, if at least 1 of
the following conditions is met:
– The child has persistent AD in spite of optimized management and topical therapy
– The child has a reliable history of an immediate reaction after ingestion of a specific food
Despite lack of evidence determining the appropriate testing age, if a child is less than
5 years old and has persistent AD, there is benefit to screening for food allergies
• Testing is time-consuming
and costly for patients
and their families
• Severely restrictive diets
may be harmful
• Early diagnosis can lead to
better management of
food allergies and reduce
the risk of exposure to
food antigens
Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
24
Who May Be At Risk for Anaphylaxis?
History of
anaphylaxis
• A previous episode of anaphylaxis1
• A previous mild or moderate reaction to2,3:
Allergens
‒ Peanuts, tree nuts, fish, and shellfish
‒ Insect venom
‒ Latex exposure
• Food allergy concomitant with2,4
Comorbidities
Concurrent
treatment
‒ Asthma
‒ Atopic dermatitis
‒ Severe allergic rhinitis
‒ Eczema
• Currently receiving any therapy with a Boxed
Warning for anaphylaxis5
1. Sicherer SH et al; Section on Allergy and Immunology, American Academy of Pediatrics. Pediatrics. 2007;119(3):638-646; 2. Simons FE. J Allergy Clin Immunol. 2009;124(4):625-636;
3. Simons FE et al. J Allergy Clin Immunol. 2007;120(suppl 1):S2-S24; 4. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58;
5. Simons FE. J Allergy Clin Immunol. 2010;125:S161-S181.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
25
Now let’s revisit our patient, Nick…
Based on what you learned, what would be some
appropriate action points for this type of patient?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
26
Patient Case: Key Action Points



NOTE: Not a real patient. This is a
patient case study for illustrative
purposes only. Not all patients who
experience anaphylaxis will exhibit
these symptoms or results.


‒ Carrying EpiPen® Auto-Injector does not prevent Nick from having an anaphylactic
reaction; hence, Nick must remain vigilant of his environment at all times1,3,4
Develop an Anaphylaxis Action Plan and review it with Nick and his caregivers
regularly1,2 ,*
Prescribe epinephrine auto-injectors and use a training device to demonstrate
correct administration technique1
Reinforce that epinephrine is the only first-line therapy for
the treatment of anaphylaxis1
‒ If experiencing anaphylaxis, use an EpiPen® Auto-Injector and seek immediate
emergency medical attention/call 9115
‒ Adjunctive therapies (antihistamines [H1, H2], albuterol, corticosteroids) are not
indicated for the treatment of anaphylaxis1
*A
sample Anaphylaxis
Action Plan is available
for download at
aaaai.org
Communicate to Nick and his caregivers that recognizing a mild reaction is
important because the severity of future anaphylactic reactions cannot be
accurately predicted based on past reactions1,2
Educate Nick and his caregivers on the benefits and importance of constant
allergen avoidance1

Counsel Nick and his caregivers to1
‒ Always carry 2 epinephrine auto-injectors
‒ Administer epinephrine auto-injector at the first signs or symptoms of anaphylaxis
1. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 2. Muñoz-Furlong A, Weiss CC. Curr Allergy Asthma Rep.
2009;9(1):57-63; 3. Burks AW et al. J Allergy Clin Immunol. 2012;129(4):906-920; 4. Lieberman P et al.
J Allergy Clin Immunol. 2010;126(3):477-480; 5. EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
27
Emergency Preparedness in the Community:
Anaphylaxis Action Plan*
•
Components of an Anaphylaxis Action Plan
should include the following:
–
–
–
–
•
•
•
Avoid known allergens whenever possible1-3
Recognize the symptoms1
Always carry two EpiPen® Auto-Injectors2,3
If experiencing anaphylaxis, use an EpiPen®
Auto-Injector and seek immediate
emergency medical attention/call 9114
Discuss with patients and caregivers
regularly, and update as necessary5
Instruct patient/ caregivers to provide plan
to school teachers, camp counselors,
coaches, etc5
Any action plan should be customized to
individual patients and office settings5
* This sample Anaphylaxis Action Plan is available for download at aaaai.org. Please visit aaaai.org to view the most current version
of their Anaphylaxis Action Plan.
1. Simons FE et al. J Allergy Clin Immunol. 2011;127(3):587-593; 2. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58; 3.
Burks AW et al. ICON: food allergy. J Allergy Clin Immunol. 2012;129(4):906-920; 4. EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009;
5. Simons FER. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
28
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors
Indications for Use
Important Safety Information
Administration Technique
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
29
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors
Indications
EpiPen® and EpiPen Jr® 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.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
30
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors
Important Safety Information
EpiPen Auto-Injectors should only be injected into the anterolateral aspect of
the thigh. DO NOT INJECT INTO BUTTOCK, OR INTRAVENOUSLY.
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.
Please see accompanying Full Prescribing Information for EpiPen ® (epinephrine) Auto-Injector 0.3 mg and
EpiPen Jr® (epinephrine) Auto-Injector 0.15 mg.
31
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors (cont’d)
Important Safety Information (cont’d)
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
transient moderate anxiety, apprehensiveness, restlessness, tremor,
weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting,
headache, and/or respiratory difficulties.
EpiPen® and EpiPen Jr® Auto-Injectors are intended for immediate selfadministration as emergency supportive therapy only and are not intended as
a substitute for immediate medical or hospital care.
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.
Please see accompanying Full Prescribing Information for EpiPen ® (epinephrine) Auto-Injector 0.3 mg and
EpiPen Jr® (epinephrine) Auto-Injector 0.15 mg.
32
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors: Key Features
EpiPen® Auto-Injector is indicated for patients at increased risk or with a history of anaphylaxis
Brightly colored
orange tip
Ergonomically
designed grip
Aids in quick
identification of
needle end
Built-in needle
protection
Protects against
needle exposure
before and after use
Designed for
single-handed
opening
Illustrated instructions
Allow for rapid
recognition of product
usage instructions
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
33
One-step, flip-top
carry case
Blue safetyrelease cap
Designed to prevent
unintentional activation
How should EpiPen® (epinephrine)
and EpiPen Jr® (epinephrine)
Auto-Injectors be administered
and dosed?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
34
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors: Directions For Use
•
•
•
•
•
•
•
Remove Auto-Injector from carrier
tube BEFORE use
Never put thumb, fingers, or hand
over orange tip
Never press or push orange tip with
thumb, fingers, or hand
The needle comes out of orange tip
Do NOT remove blue safety release
until ready to use
Do NOT use if solution is discolored
Do NOT place Patient Insert or any
other foreign objects in carrier with
Auto-Injector, as this may prevent
you from removing the Auto-Injector
for use
EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
35
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors:
Directions to Remove Auto-Injector From the Carrier Tube
1
Flip open the yellow cap of the EpiPen® or the green
cap of the EpiPen Jr® Auto-Injector carrier tube
2
Remove the EpiPen® or EpiPen Jr® Auto-Injector
by tipping and sliding it out of the carrier tube
EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
36
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors:
Directions to Use the Auto-Injector
1
Grasp unit with the orange tip pointing downward
2
Form fist around the unit (orange tip down)
3
With your other hand, pull off the blue
safety release
4
Hold orange tip near outer thigh
DO NOT INJECT INTO BUTTOCK
EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
37
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors:
Directions to Use the Auto-Injector (cont’d)
5
Swing and firmly push against outer thigh until it clicks
so that unit is perpendicular (at 90° angle) to the thigh
(Auto-injector is designed to work through clothing)
6
Hold firmly against thigh for approximately 10 seconds
to deliver drug. (The injection is now complete.
The window on auto-injector will be obscured)
7
Remove unit from thigh (the orange needle cover will
extend to cover needle) and massage injection area
for 10 seconds
8
Call 911 and seek immediate medical attention
9
Take the used auto-injector with you to the hospital
emergency department
EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
38
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors: Immediately After Use
IMMEDIATELY AFTER USE
• Go immediately to the nearest hospital emergency department or call 911
– You may need further medical attention
– Take your used auto-injector with you
• Tell the doctor that you have received an injection of epinephrine in your thigh
• Give your used EpiPen® or EpiPen Jr® Auto-Injector to the doctor for inspection
and proper disposal
• Do not attempt to take the auto-injector apart
Note: Most of the liquid (about 85%) stays in the auto-injector and cannot be reused.
However, you have received the correct dose of the medication if the orange needle tip
is extended and the window is obscured. Trainer label has blue background color. Blue
background labeled trainer contains no needle and no drug.
EpiPen [patient insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
39
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors: Weight-Based Dosing
• Selection of the appropriate dosage strength is determined
according to patient body weight
– EpiPen® Auto-Injector delivers 0.3 mg epinephrine injection and
is intended for patients who weigh ≥30 kg (≥66 lb)
– EpiPen Jr® Auto-Injector delivers 0.15 mg epinephrine injection and
is intended for patients who weigh 15-30 kg (33-66 lb)
EpiPen [package insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
40
Why is it important to carry 2
epinephrine auto-injectors
at all times?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
41
EpiPen 2-Pak® (epinephrine) Auto-Injectors Ensure
Availability of a Second Dose if Needed
• The need for additional epinephrine cannot be
reliably predicted at the onset of the reaction1,2
• Up to 2 doses can be administered as needed in
both adults and children3
– More than 2 sequential doses of epinephrine
should only be administered under direct
medical supervision
• NIH-NIAID Food Allergy Guidelines: If a patient
responds poorly to the initial dose or has
ongoing or progressive symptoms despite initial
dosing, repeated dosing may be required after
5 to 15 minutes2
• Having multiple EpiPen® Auto-Injectors accessible
in various locations—at home, school, or
work―can help patients in the event of an
emergency
1. Lieberman P et al. J Allergy Clin Immunol. 2010;126(3):477-480; 2. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):
S1-S58; 3. EpiPen [package insert]. Napa, CA: Dey Pharma, L.P.; 2009.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
42
What is the role of the Health Care
Provider in maintaining
continuity of care?
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
43
Anaphylaxis Long-term Risk Management for
Patients and Caregivers
• Obtain a detailed patient history to assess risk
Identify patients at
risk and educate on
• Communicate the key signs and symptoms of anaphylaxis
to patients and their caregivers
anaphylaxis symptoms and
allergen avoidance1-5
• Explain the benefits and importance of constant allergen avoidance
Prescribe EpiPen®
(epinephrine) AutoInjectors and educate on
when and how they
should be used1-5
Maintain continuity
of care3-5
• Prescribe 2 doses of epinephrine auto-injector
• Explain that carrying EpiPen® Auto-Injector does not prevent
patients from having an anaphylactic reaction; hence, patients
must remain vigilant of their environment at all times
• Regularly train patients and caregivers in the office on the
use of EpiPen® Auto-Injector, while emphasizing the need
for prompt administration
• Develop an Anaphylaxis Action Plan*
• Implement a plan for monitoring expiration dates
• Follow-up with health care professional for further evaluation
*Key components of an Anaphylaxis Action Plan have been defined on Slide 28.
1. Lieberman P et al. J Allergy Clin Immunol. 2010;126(3):477-480; 2. Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181; 3. Sicherer SH, et al. Pediatrics.
2010;126(6):1232-1239; 4. Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol.
2010;126(6 suppl):S1-S58; 5. Burks AW. J Allergy Clin Immunol. 2012;129(4):906-920.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
44
Advise Your Patients to Visit MyEpiPen.com
MyEpiPen.com
Advise your patients that they can register their EpiPen® (epinephrine)
and EpiPen Jr® (epinephrine) Auto Injectors at MyEpiPen.com and find out
more about:
•EpiPen® EXPIRATION DATE REMINDER PROGRAM to inform patients when their autoinjector will expire and the need for a refill or a new prescription. Signing up for this
program is FREE
•Registering up to 6 EpiPen® and EpiPen Jr® Auto-Injectors and receiving automatic
e-mail EXPIRATION DATE REMINDERS
•Instructions on how to use the EpiPen® Auto-Injector
For more information about EpiPen and EpiPen Jr Auto-Injectors
and proper use of the product, visit EpiPen.com
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
45
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors
Important Safety Information
EpiPen Auto-Injectors should only be injected into the anterolateral aspect of
the thigh. DO NOT INJECT INTO BUTTOCK, OR INTRAVENOUSLY.
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.
Please see accompanying Full Prescribing Information for EpiPen ® (epinephrine) Auto-Injector 0.3 mg and
EpiPen Jr® (epinephrine) Auto-Injector 0.15 mg.
46
EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)
Auto-Injectors (cont’d)
Important Safety Information (cont’d)
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
transient moderate anxiety, apprehensiveness, restlessness, tremor,
weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting,
headache, and/or respiratory difficulties.
EpiPen® and EpiPen Jr® Auto-Injectors are intended for immediate selfadministration as emergency supportive therapy only and are not intended as
a substitute for immediate medical or hospital care.
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.
Please see accompanying Full Prescribing Information for EpiPen ® (epinephrine) Auto-Injector 0.3 mg and
EpiPen Jr® (epinephrine) Auto-Injector 0.15 mg.
47
Prescribe EpiPen® (epinephrine) Auto-Injector for
Your Patients at Risk For Anaphylaxis
•
•
Identify patients who have a history of anaphylaxis
or who are at risk
Educate on the importance of allergen avoidance
and the need to develop an Anaphylaxis Action Plan
–
•
•
Carrying EpiPen® Auto-Injector does not prevent patients from
having an anaphylactic reaction; hence, patients must remain
vigilant of their environment at all times
Instruct your patients to always have an EpiPen
2-Pak® available
Remind patients to refill their EpiPen 2-Pak®
prescription as soon as it expires
– Visit myepipen.com to register for automatic
expiration date reminders
•
Inform patients that EpiPen 2-Pak® is covered by most
insurance plans
•
EpiPen® has been the #1 prescribed epinephrine
auto-injector for over 20 years1
There is no FDA-approved
therapeutically equivalent
generic substitute for EpiPen®
Auto-Injector available2
1. Data on file. Mylan Specialty L.P.;
2. U.S. Department of Health and Human Services Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations. 32nd ed. Washington,
DC: U.S. Department of Health and Human Services; 2012.
Please see Important Safety Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information.
48
Part No: EPI12-5001