~1 in 13 Children in the United States suffers from food allergies Gupta RS et al. Pediatrics....

~1 in 13Children in the United Statessuffers from food allergies

Gupta RS et al. Pediatrics. 2011;128(1):e9-e17.

2

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.

Food-Induced Anaphylaxis Gains National Media Attention

Survey: Many Restaurant Workers Don't Understand Food AllergiesTime - April 15, 2011

It is Time for National Education of Life-Threatening Allergic Reactions The Huffington Post - October 4, 2011

Food Allergies Can be DeadlyThe Atlanta Journal-Constitution - August 22, 2011

Girl's death highlights allergy safety in schools CNN - January 11, 2012

Finding Food Allergy Allies; Schools, States, Restaurants Take Steps; Beyond the Peanut-Free TableThe Wall Street Journal - February 27, 2012New Law Hopes To Help Schools Adapt To

Deadly Food Allergies KSHB 41 (NBC affiliate) Kansas City, MO - February 28, 2012

Study: Food Allergies More Common, More Severe Among ChildrenCNN - June 20, 2011


(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information. 3

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

The Role of EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors for Patients at Risk for Anaphylaxis

4



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

5



Importance of Allergen Avoidance andHaving 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.



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

• He describes his symptoms as “mild” • Upon returning home, his mother gave

him an antihistamine and it "took care of the problem"

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.

7



What is anaphylaxis?

8



Defining Anaphylaxis

Anaphylaxis is a severe systemic

allergic reaction that is rapid in onset and can cause death1,2

Patients at risk for anaphylaxisshould have a long-term allergy

management plan1

Patients at risk for anaphylaxisshould have a long-term allergy

management plan1

Poses serious consequences for at-risk patients1

Poses serious consequences for at-risk patients1

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.

Often occurs in the community setting3,4

Often occurs in the community setting3,4

9



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.

10



Food Is the Most Common Trigger of Anaphylaxisin 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.

11



Food Allergies and Related Conditions in Children

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.

• 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

12



Other Triggers of Anaphylaxis

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.

Exercise3Exercise3 Idiopathic Anaphylaxis4Idiopathic Anaphylaxis4

?

Insect venom, medications, and latex1,2

Insect venom, medications, and latex1,2

13



What signs and symptoms may be associated with anaphylactic

reactions?

14



Common Signs and Symptoms of Anaphylaxis

*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.

Airway*• 70% of episodes1

• Larynx: pruritus and tightness in throat; dysphonia and hoarseness2

• Lung: dyspnea, chest tightness, wheezing/bronchospasm2

Skin • 80%- 90% of episodes1

• Urticaria, pruritus, flushing2

• Mucosal tissue: pruritus and swelling of lips, tongue, uvula/palate2

Gastrointestinal tract• 30%- 45% of episodes1

• Nausea, cramping, abdominalpain, vomiting, diarrhea2

Cardiovascular system*• 10%- 45% of episodes1

• Chest pain, hypotension, tachycardia, weak pulse, dizziness, fainting2

Central nervous system• 10%-15% of episodes1

• Uneasiness, throbbing headache, dizziness, confusion, tunnel vision2

15



What criteria are used to clinically diagnose anaphylaxis?

16



When Is It Anaphylaxis? (Sampson Criteria)

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.

• Anaphylaxis is highly likely when any 1 of the 3 criteria below is fulfilled1

Involvement of the skin and/or mucosal tissue, and (a) respiratory compromise

or (b) reduced blood pressure

CRITERION 1:Unknown allergen exposure

• Involvement of the skin-mucosal tissue

• Respiratory compromise

• Reduced blood pressure

• Persistent GI symptoms

CRITERION 2:Likely allergen exposure

(2 or more of the following)

• Reduced blood pressure

CRITERION 3:Known allergen exposure

• CV symptoms and respiratory distress are not mandatory for a diagnosis of anaphylaxis2

17



The Continuum of Anaphylaxis

Anaphylaxissigns & symptoms

(minutes to hours)1,2,*



Signs & symptomsoccur within 1-72 hours

(typically 8 hours)4



* 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.

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

• The severity of an initial reaction does not predict the severity of future reactions3

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 experiencebiphasic or protracted reactions5

Allergenexposure 1

Like

lihoo

d of

Occ

urre

nce

Time

Initial Reaction Biphasic reaction (~20% of cases4)

5m 10m 15m 20m 25m 30m 1h 8h 72h2h 3h 4h 5h 6h 7h 9h 10h

18



What do current guidelines recommend as first-line treatment for anaphylaxis?

19



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

* 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.

NIAID-SponsoredExpert Panel

on Food Allergy3

• Epinephrine is the first-line 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 auto-injector should be prescribed

ICON: Food Allergy4

• Epinephrine is the first-line treatment* for anaphylaxis

• Upon discharge, 2 doses of epinephrine auto-injector should be prescribed

• Patients must be educated on when and how to use the epinephrine auto-injector device

20



Pharmacologic Effects of Epinephrine

BP=blood pressure; BD=bronchodilation.Simons FE. J Allergy Clin Immunol. 2010;125(suppl 2):S161-S181.

Epinephrine’s α1- and 2-adrenergic effects help alleviate thelife-threatening symptoms of anaphylaxis in most organ systems

Vasoconstriction BP Mucosal edema (larynx)

Relieveshypotension and shock

Additional pharmacologic effects: at β1-receptor: heart rate; cardiac contraction force.

Epinephrine

Relieves upper airway obstruction

BD Mediator release

Wheezing Hives

α1-receptor β2-receptor

21



Use Epinephrine Auto-Injector Promptly at the First Signs and Symptoms of Anaphylaxis









Allergenexposure1

Like

lihoo

d of

Occ

urre

nce Initial Reaction Biphasic reaction (~20% of cases4)

5m 10m 15m 20m 25m 30m 1h 8h 72h2h 3h 4h 5h 6h 7h 9h 10h

* 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.

• 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

• There are no absolute contraindications to the use of epinephrine in a life-threatening situation3

• ~20% of cases may warrant a second dose of epinephrine4

• Benefits of epinephrine far outweigh the risks of unnecessary dosing2

Time

22



Antihistamines Are Recommendedas 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

Boyce JA et al; NIAID-Sponsored Expert Panel. J Allergy Clin Immunol. 2010;126(6 suppl):S1-S58.

“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

23



What factors may increase the risk for anaphylaxis?

24



Who May Be At Risk? Screening Children for Food Allergies

Despite lack of evidence determining the appropriate testing age, if a child is less than5 years old and has persistent AD, there is benefit to screening 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

• 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.

25



Who May Be At Risk for Anaphylaxis?

Allergens

• A previous mild or moderate reaction to2,3:‒ Peanuts, tree nuts, fish, and shellfish‒ Insect venom‒ Latex exposure

Concurrent treatment

• Currently receiving any therapy with a Boxed Warning for anaphylaxis5

Comorbidities

• Food allergy concomitant with2,4

‒ Asthma‒ Atopic dermatitis

‒ Severe allergic rhinitis‒ Eczema

• A previous episode of anaphylaxis1

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.

History of anaphylaxis

26



Now let’s revisit our patient, Nick…

Based on what you learned, what would be some appropriate action points for this type of patient?

27



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.

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.

Counsel Nick and his caregivers to1

‒ Always carry 2 epinephrine auto-injectors‒ Administer epinephrine auto-injector at the first signs or symptoms of anaphylaxis

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

‒ 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

28



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.


(epinephrine) Auto-Injector 0.15 mg on slides 31, 32, 46, and 47, and accompanying full Prescribing Information. 29

Indications for Use Important Safety InformationAdministration Technique

EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors

30




IndicationsEpiPen® 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.

31

Please see accompanying Full Prescribing Information for EpiPen® (epinephrine) Auto-Injector 0.3 mg and EpiPen Jr® (epinephrine) Auto-Injector 0.15 mg.


Important Safety InformationEpiPen 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.

32


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 self-administration 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.

33



EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors: Key Features

Ergonomicallydesigned grip

Ergonomicallydesigned grip

One-step, flip-topcarry case

One-step, flip-topcarry case

Designed for single-handed opening

Brightly coloredorange tip

Brightly coloredorange tip

Aids in quickidentification ofneedle end

Designed to preventunintentional activation

Blue safety-release cap

Blue safety-release cap

Allow for rapidrecognition of productusage instructions

Illustrated instructionsIllustrated instructions

Protects againstneedle exposurebefore and after use

Built-in needleprotection

Built-in needleprotection

EpiPen® Auto-Injector is indicated for patients at increased risk or with a history of anaphylaxis

34



How should EpiPen® (epinephrine) and EpiPen Jr® (epinephrine)

Auto-Injectors be administered and dosed?

35



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.

36




1 Flip open the yellow cap of the EpiPen® or the green cap of the EpiPen Jr® Auto-Injector carrier tube

Remove the EpiPen® or EpiPen Jr® Auto-Injector by tipping and sliding it out of the carrier tube

2

EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors: Directions to Remove Auto-Injector From the Carrier Tube

37




EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors: Directions to Use the Auto-Injector

1 Grasp unit with the orange tip pointing downward

Form fist around the unit (orange tip down)2

With your other hand, pull off the blue safety release3

Hold orange tip near outer thighDO NOT INJECT INTO BUTTOCK4

38




5Swing and firmly push against outer thigh until it clicksso that unit is perpendicular (at 90° angle) to the thigh(Auto-injector is designed to work through clothing)

Hold firmly against thigh for approximately 10 seconds to deliver drug. (The injection is now complete. The window on auto-injector will be obscured)

6

Remove unit from thigh (the orange needle cover will extend to cover needle) and massage injection area for 10 seconds

7

Call 911 and seek immediate medical attention8

Take the used auto-injector with you to the hospital emergency department9

EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors: Directions to Use the Auto-Injector (cont’d)

39



EpiPen® (epinephrine) and EpiPen Jr® (epinephrine) Auto-Injectors: Immediately After UseIMMEDIATELY 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.

40



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.

41



Why is it important to carry 2 epinephrine auto-injectors

at all times?

42



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.

43



What is the role of the Health Care Provider in maintaining

continuity of care?

44



Anaphylaxis Long-term Risk Management for Patients and Caregivers

*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.

• 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 theuse of EpiPen® Auto-Injector, while emphasizing the needfor prompt administration

Prescribe EpiPen® (epinephrine) Auto- Injectors and educate on when and how they should be used1-5

• Obtain a detailed patient history to assess risk• Communicate the key signs and symptoms of anaphylaxis

to patients and their caregivers• Explain the benefits and importance of constant allergen

avoidance

Identify patients atrisk and educate on anaphylaxis symptoms and allergen avoidance1-5

• Develop an Anaphylaxis Action Plan*

• Implement a plan for monitoring expiration dates• Follow-up with health care professional for further evaluation

Maintain continuityof care3-5

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Advise Your Patients to Visit MyEpiPen.com

MyEpiPen.comMyEpiPen.com

For more information about EpiPen and EpiPen Jr Auto-Injectors and proper use of the product, visit EpiPen.com

For more information about EpiPen and EpiPen Jr Auto-Injectors and proper use of the product, visit EpiPen.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 auto-injector 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

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Important Safety InformationEpiPen 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.

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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 self-administration 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.

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There is no FDA-approved therapeutically equivalent generic substitute for EpiPen® Auto-Injector available2

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

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.

Part No: EPI12-5001

~1 in 13 Children in the United States suffers from food allergies Gupta RS et al. Pediatrics....

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