the severe allergy & anaphylaxis playbook

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Football legend Jerome Bettis tackles severe allergies.

The Severe Allergy &Anaphylaxis Playbook

Jerome Bettis Presents:

Indication Auvi-Q™ (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these 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 use.

Please see additional Important Safety Information on last page and accompanying full Prescribing Information.The health information contained herein is provided for general educational purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.

©2013 Sanofi U.S. LLC. All rights reserved. Last Update: MAY 2013 US.EAI.13.04.031

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Study These Plays to Help Be Ready

Table of ContentsClick on a chapter to go straight to it.

Introduction �� 2

Jerome’s Top 5 Plays �� 3

Food Allergy Plays ��4-6

Bee & Wasp Allergy Plays ��7-8

Latex Allergy Plays�� 8

Exercise-Induced Allergy Plays �� 9

Medication Allergy Plays �� 10

Plays for the House �� 11

Plays for School ��12-13

Plays for Travel ��14-15

Important Safety Information �� 16

On the field, part of my success came from always being prepared. I would study my playbook every day to help give me the edge I needed to stay a step ahead of my opponent.

Off the field, I live with a severe shellfish allergy. And I make the same effort to stay a step ahead of my allergen by always avoiding it and knowing how to act, and react, in situations where I might be at risk for anaphylaxis.

If you’re at risk for anaphylaxis too, this playbook is designed to teach you valuable plays to help you avoid your allergens and be better prepared. Whether you’re allergic to a type of food, stinging insects, latex, or other trigger, there are plays inside for you. So find your plays and study them.

Jerome Bettis

The Severe Allergy & Anaphylaxis Playbook

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Indication Auvi-Q™ (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these 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 use�

Please see additional Important Safety Information on last page and accompanying full Prescribing Information� 3

Jerome’s Top 5 Plays——————————————————————————————————————

Avoid your allergens� If you’re at risk for severe allergic reactions, it’s the best play you can make� Period�

Always carry Auvi-Q™(epinephrine injection, USP)� Avoiding my allergens is my first play, but there’s always a chance something could slip through my defense and cause a severe allergic reaction� So I always carry 2 Auvi-Q epinephrine auto-injectors�

Have a plan� And share it� An Anaphylaxis Action Plan is essential to have with you if you are at risk for severe allergic reactions� It lets people know what you’re allergic to, who to contact in case of an emergency, and where you keep your Auvi-Q�

Practice� Practice� Practice� Make sure you know how to use your epinephrine auto-injector by practicing with your trainer regularly� Every Auvi-Q prescription comes with a trainer you can use to prepare yourself and others�

Get emergency medical attention� If or when a severe allergic reaction occurs, it’s extremely important to seek immediate medical treatment after using Auvi-Q�

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Auvi-Q

Print this section

http://www.auvi-q.com/media/pdf/Action-Plan.pdf

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Food Allergy Plays——————————————————————————————————————

Food allergies are among the most common types of severe allergies� If you’re allergic to a food, here are some plays for you to consider�

Do your dishes� For a food-allergy–safe meal, be sure to thoroughly clean all utensils (for serving and eating), cookware, glassware, serving dishes, and storage containers before preparing and serving�

Keep it together� It’s a good play to organize a special shelf of the refrigerator or pantry for “safe” foods if you have a food allergy�

Double up� It’s a smart play to buy two packages of dips, spreads, butters, and condiments that are in a container into which a contaminated utensil could be dipped multiple times� Be sure to distinguish the packages with labels or indelible ink, so it is clear which one is free from the allergen�

The Severe Allergy & Anaphylaxis Playbook Print this section

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Read the label! Then read it again!

No matter what foods you may be allergic to, this is the most important play you can make.

US food labels are required to indicate if a food product contains any of the 8 major food allergens. ALWAYS read the labels of the foods you buy to make sure all the ingredients are safe, because recipes and formulations change all the time. If you’re unsure, call the manufacturer to confirm that the food is safe, or don’t eat/drink it.

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Plays for Dining Out———————————————

If you’re going out to eat, there are some important plays you should study beforehand� Check ‘em out�

Know what you’re eating� It’s a good play to visit a restaurant’s Web site to check the menu for allergy-friendly options�

Put it in writing� Fill out some Dining Out Cards that list all the ingredients you or your child is allergic to� Share one with the restaurant staff before ANY food is brought to your table�

Talk to the waitstaff� Make sure they clearly communicate every ingredient in each dish to you�

Get confirmation� Verify all the ingredients and preparation methods with the restaurant manager� And if you still have questions, speak directly to the chef�

Be your own clean machine� Wipe down utensils with a disinfectant wipe or a napkin before you use them�

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http://www.auvi-q.com/Media/pdf/Eating-Out-Allergy-Card.pdf

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Picnicking Plays———————————————

Planning on joining friends and family for a summer feast outdoors? Take these plays along�

Make it at home� You can help ensure your food is allergy friendly when you make it at home� That’s not always the case with store-bought or take-out meals� So consider homemade dishes� And make your mom proud�

Pack some packets� Condiment packets are always a good play� They help avoid cross-contamination because you only use them once then throw them away�

Use a tablecloth� Besides making your table look good, it helps to protect against allergens that may have been left from previous meals�

Grill first! Otherwise there’s a chance your food could get contaminated with allergens from previous grill masters� Speed is key for this play� If you don’t get there first, you can help protect yourself or your child by wrapping your food in foil before grilling�

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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 use�


Bee & Wasp Allergy Plays———————————————————————————————————

Severe allergic reactions to bee, wasp, or other insect stings are not uncommon� Here are some plays you can make to keep yourself better protected�

Know your enemy� Bees and wasps may look for food among flowers, plants, and garbage� So try to avoid wearing bright floral patterns and be extra aware on garbage day�

Beware of sweets� Sweet substances and sugary drinks can attract bees and wasps� So keep desserts and soft drinks covered when you’re dining outdoors�

Act quickly� If you are stung by a bee, wasp, or other stinging insect, scrape the stinger from the skin with something firm, like your fingernail or a plastic credit card, then use Auvi-Q™ (epinephrine injection, USP) to administer epinephrine� And remember to always seek immediate medical attention after using Auvi-Q�

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Bee & Wasp Allergy Plays (cont’d )——————————————————————————————————————

No bare feet� Biting or stinging ants like to hang out in the grass� Sometimes bees and wasps do, too� So it’s a good play to wear shoes when you’re walking outside�

Play cover defense� Wearing close-fitting long sleeves and pants can reduce your chances of getting stung� So can using certain insect repellents�

Don’t panic� If you come face to face with a stinging insect, stay calm� Don’t swat at it� Just walk away slowly�

Latex Allergy Plays——————————————————————————————

Party smart� Balloons are fun and festive, but many are made of latex� So be sure to look for non-latex alternatives for all your celebrations�

Give your healthcare provider a heads-up� Gloves worn by healthcare providers may be made of latex� If you have an appointment, let them know if you or your child has a latex allergy, so they can be sure to use non-latex ones�

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Exercise-induced anaphylaxis is potentially life-threatening� Food-dependent exercise-induced anaphylaxis (a type of exercise-induced anaphylaxis) is also a danger� It’s different from a food allergy and happens when the ingestion of a particular food, combined with exercise, triggers a severe allergic reaction�

Watch the clock� It is recommended that people with food-dependent exercise-induced anaphylaxis not exercise within 4 to 6 hours of eating, and wait an hour after exercising before eating�

Check with the pros�If you are at risk for exercise-induced anaphylaxis, get with your healthcare professional to plan or modify your workout routine�

Team up� When you’re at risk for exercise-induced anaphylaxis, it’s always a good play to work out with someone who’s aware of your allergy and knows what to do in case of a severe allergic reaction�

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Exercise-Induced Allergy Plays——————————————————————————————————————

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Some people have severe allergic reactions to certain medications� If you’re one of them, these plays are for you�

Follow directions� It’s a smart play to take all medications exactly as your physician prescribes� Contact him or her immediately if you have side effects that concern you, or you suspect a drug allergy has occurred� If your symptoms are severe, get medical help immediately�

Make a list� Keep a record of any drugs you’re taking and make a note if you’ve had reactions to any medications� Share your list with your physician and ask if you should be avoiding any particular drugs, or if you should be wearing a bracelet that lets people know about your allergy�

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Medication Allergy Plays——————————————————————————————————————

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Plays for the House——————————————————————————————————————

When you live at risk for severe allergic reactions, it’s obviously important that your home be allergy friendly� Run these plays to make sure it is�

Put the writing on the wall� Print out a list of your allergens, then post it on your fridge or around the house so it can help your family and friends remember�

Clean house� Once you know your allergy triggers, you’ll want to get them out of your home� It’s a smart play to have your family and friends help you find the allergens that may be on your shelves� That way they’ll know what you need to avoid as well�

Take your family and friends to the doctor� Some people have reported facing skepticism from friends and family members after being diagnosed with severe allergies� One thing that may help prevent that is to have your doctor or allergist explain the seriousness of it to everyone�

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http://www.auvi-q.com/Media/pdf/Around-The-House-Reminders.pdf


Important Safety Information Each Auvi-Q contains a single dose of epinephrine� Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY� If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment�


Plays for School——————————————————————————————————————

When your child is at risk for severe allergic reactions, sending them to school can be scary� Here are some plays you can make to see to it that your child and the school are well prepared�

Coach your child’s teachers� Set up a meeting with your child’s teachers to discuss his or her allergens, how to help avoid them, and how to use Auvi-Q™ (epinephrine injection, USP) in an emergency�

Make an appointment with the nurse� Talk to the school nurse to make sure the school knows what your child is allergic to� Fill out and pass around your child’s Allergy ID Card to the school nurse, teachers, and cafeteria workers to remind them what allergens your child needs to avoid�

Know the school rules� Make sure to call the school and ask them what their procedure is for children who need to carry epinephrine auto-injectors, like Auvi-Q�

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http://www.auvi-q.com/Media/pdf/Allergy-ID-Card.pdf

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Plays for School (cont’d )——————————————————————————————————————

Have a plan� It’s a smart play to have an up-to-date Anaphylaxis Action Plan in place, even if your child has a 504 Plan* in place with the school�

Teach your child to speak up� Encourage your child to use his or her own words to describe their symptoms� Let them know it’s not whining or complaining and that it might make all the difference in an emergency�

Stop the bullying� Sometimes kids with severe allergies get harassed by other kids at school� Make sure that your child knows it’s important to talk to you or their teacher if it’s happening to them�

*A 504 Plan is designed to accommodate your child under the Americans with Disabilities Act�

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http://www.auvi-q.com/media/pdf/Action-Plan.pdf


Important Safety Information Side effects may be increased in patients with certain medical conditions, or who take certain medicines� These include asthma, allergies, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure, and heart disease.


Plays for Travel——————————————————————————————————————

Traveling can be a challenge for people at risk for severe allergic reactions� Follow these simple plays to help keep yourself better prepared�

Educate your hosts� Whether you’re traveling halfway across the world or 1 town away, let your hosts, including restaurant and hotel staff, know about your severe allergies, even if it means learning to tell them in other languages�

Fly right�It’s all about speed� Avoid delays at TSA security checkpoints by always bringing a copy of your Auvi-Q™ (epinephrine injection, USP) prescription with you�

Flight attendants are on your team� Tell them about your severe allergies and that you’d like to preboard so you can clean your seat and surrounding area with a disinfectant wipe and let your neighbors know about your allergies�

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http://www.auvi-q.com/traveling-with-severe-allergies


Important Safety Information The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety� These side effects go away quickly, especially if you rest�


Plays for Travel (cont’d )——————————————————————————————————————

Always play clean� Make sure the surfaces around your seat are allergen free by wiping them down with a disposable disinfectant wipe�

Make yourself heard�Let the people sitting around you know about your allergies�

Accessibility is key�Keep your Auvi-Q™ (epinephrine injection, USP) auto-injectors in a place where they can be easily reached by you or someone else�

Get everyone on the same page�If you’re traveling in a group, let people know about any severe allergies you have and what to do in case of a severe allergic reaction�

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Keep Your Playbook HandyNow that you know the plays that might work for you, study them� They can help you stay a step ahead of your allergens� But remember to always be aware of what’s going on around you� And always keep your playbook, and your Auvi-Q, close by�

IndicationAuvi-QTM (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions�

Important Safety InformationAuvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care� Seek immediate medical treatment after use� Each Auvi-Q contains a single dose of epinephrine� Auvi-Q should only be injected into your outer thigh� DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY� If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment� Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms�

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor all the medicines you take, especially medicines for asthma� Side effects may be increased in patients with certain medical conditions, or who take certain medicines� These include asthma, allergies, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure, and heart disease�

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety� These side effects go away quickly, especially if you rest�

Talk to your healthcare professional to see if Auvi-Q is right for you�

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.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Auvi-Q™ safely andeffectively. See full prescribing information for Auvi-Q™.

Auvi-Q™ (epinephrine injection, USP) 0.3 mg, 0.15 mg Auto-Injector

Initial U.S. Approval: 2012

—————————————— INDICATIONS AND USAGE ——————————————Auvi-Q™ contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist,indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. (1)

————————————— DOSAGE AND ADMINISTRATION —————————————• Patients greater than or equal to 30 kg (66 lbs): Auvi-Q™ 0.3 mg (2)• Patients 15 to 30 kg (33 lbs – 66 lbs): Auvi-Q™ 0.15 mg (2)

Inject Auvi-Q™ intramuscularly or subcutaneously into the anterolateral aspect of the thigh, throughclothing if necessary. Each device is a single-use injection. (2)

———————————— DOSAGE FORMS AND STRENGTHS ————————————• Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (3)• Injection, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector (3)

——————————————— CONTRAINDICATIONS ———————————————None (4)

————————————— WARNINGS AND PRECAUTIONS —————————————• In conjunction with use, seek immediate medical or hospital care. (5.1)• Do not inject intravenously, into buttock, or into digits, hands, or feet. (5.2)

• The presence of a sulfite in this product should not deter use. (5.3)• Administer with caution in patients with heart disease; may aggravate angina pectoris or

produce ventricular arrhythmias. (5.4)

——————————————— ADVERSE REACTIONS ———————————————Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weak-ness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratorydifficulties. (6)

To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

——————————————— DRUG INTERACTIONS ———————————————• Cardiac glycosides or diuretics: observe for development of cardiac arrhythmias. (7)• Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain

antihistamines: potentiate effects of epinephrine. (7)• Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of

epinephrine. (7)• Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of

epinephrine. (7)• Ergot alkaloids: may reverse the pressor effects of epinephrine. (7)

———————————— USE IN SPECIFIC POPULATIONS ————————————• Elderly patients may be at greater risk of developing adverse reactions. (5.4, 8.5)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

Revised: 09/2012

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 EMERGENCY TREATMENT

5.2 INCORRECT LOCATIONS OF INJECTION

5.3 ALLERGIC REACTIONS ASSOCIATED WITH SULFITE

5.4 DISEASE INTERACTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 PREGNANCY

8.3 NURSING MOTHERS

8.4 PEDIATRIC USE

8.5 GERIATRIC USE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 MECHANISM OF ACTION

12.2 PHARMACODYNAMICS

13 NONCLINICAL TOXICOLOGY

13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 HOW SUPPLIED

16.2 STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 ADMINISTRATION AND TRAINING

17.2 ADVERSE REACTIONS

17.3 ACCIDENTAL INJECTION

17.4 STORAGE AND HANDLING

*Sections or subsections omitted from the full prescribing information are not listed

FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEAuvi-Q™ is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxisto stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets andfire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs,diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathicanaphylaxis or exercise-induced anaphylaxis.Auvi-Q™ is intended for immediate administration in patients who are determined to be at increasedrisk for anaphylaxis, including individuals with a history of anaphylactic reactions.Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension,syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure,convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due tolaryngeal spasm, pruritus, rashes, urticaria or angioedema.Auvi-Q™ is intended for immediate self-administration as emergency supportive therapy only and isnot a substitute for immediate medical care.2 DOSAGE AND ADMINISTRATIONSelection of the appropriate dosage strength (Auvi-Q™ 0.3 mg or Auvi-Q™ 0.15 mg) is determinedaccording to patient body weight.

• Patients greater than or equal to 30 kg (approximately 66 pounds or more): Auvi-Q™ 0.3 mg• Patients 15 to 30 kg (33 pounds to 66 pounds): Auvi-Q™ 0.15 mg

Inject Auvi-Q™ intramuscularly or subcutaneously into the anterolateral aspect of the thigh, throughclothing if necessary.Each Auvi-Q™ contains a single dose of epinephrine for single-use injection. Since the doses ofepinephrine delivered from Auvi-Q™ are fixed, consider using other forms of injectable epinephrine ifdoses lower than 0.15 mg are deemed necessary.The prescriber should carefully assess each patient to determine the most appropriate dose ofepinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. Withsevere persistent anaphylaxis, repeat injections with an additional Auvi-Q™ may be necessary. Morethan two sequential doses of epinephrine should only be administered under direct medical supervision[see WARNINGS AND PRECAUTIONS (5.1)].The epinephrine solution in the viewing window of Auvi-Q™ should be inspected visually for particulatematter and discoloration. Epinephrine is light sensitive and should be stored in the outer case providedto protect it from light [see STORAGE AND HANDLING (16.2)].

3 DOSAGE FORMS AND STRENGTHS• Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector• Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector

4 CONTRAINDICATIONSNone.5 WARNINGS AND PRECAUTIONS5.1 EMERGENCY TREATMENTAuvi-Q™ is not intended as a substitute for immediate medical care. In conjunction with theadministration of epinephrine, the patient should seek immediate medical or hospital care. Morethan two sequential doses of epinephrine should only be administered under direct medical supervision[see INDICATIONS AND USAGE (1), DOSAGE AND ADMINISTRATION (2) and PATIENT COUN-SELING INFORMATION (17.1)].5.2 INCORRECT LOCATIONS OF INJECTIONAuvi-Q™ should ONLY be injected into the anterolateral aspect of the thigh [see DOSAGE ANDADMINISTRATION (2) and PATIENT COUNSELING INFORMATION (17.1)].

• Do not inject intravenously. Large doses or accidental intravenous injection of epinephrine mayresult in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators cancounteract the marked pressor effects of epinephrine if there is such inadvertent administration.

• Do not inject into buttock. Injection into the buttock may not provide effective treatment ofanaphylaxis. Advise the patient to go immediately to the nearest emergency room for furthertreatment of anaphylaxis.

• Do not inject into digits, hands or feet. Since epinephrine is a strong vasoconstrictor, accidentalinjection into the digits, hands or feet may result in loss of blood flow to the affected area. Advisethe patient to go immediately to the nearest emergency room and to inform the healthcare providerin the emergency room of the location of the accidental injection. Treatment of such inadvertentadministration should consist of vasodilation, in addition to further appropriate treatment ofanaphylaxis [see ADVERSE REACTIONS (6)].

5.3 ALLERGIC REACTIONS ASSOCIATED WITH SULFITEEpinephrine is the preferred treatment for serious allergic reactions or other emergency situations eventhough this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-typereactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes incertain susceptible persons.

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The presence of a sulfite in this product should not deter administration of the drug for treatment ofserious allergic or other emergency situations even if the patient is sulfite-sensitive.The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.5.4 DISEASE INTERACTIONSSome patients may be at greater risk for developing adverse reactions after epinephrine administration.Despite these concerns, it should be recognized that the presence of these conditions is not acontraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patientswith these conditions, and/or any other person who might be in a position to administer Auvi-Q™ toa patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances underwhich epinephrine should be used.

• Patients with Heart DiseaseEpinephrine should be administered with caution to patients who have heart disease, includingpatients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. Insuch patients, or in patients who are on drugs that may sensitize the heart to arrhythmias,epinephrine may precipitate or aggravate angina pectoris as well as produce ventriculararrhythmias [see DRUG INTERACTIONS (7) and ADVERSE REACTIONS (6)].

• Other Patients and DiseasesEpinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderlyindividuals, and pregnant women. Patients with Parkinson’s disease may notice a temporaryworsening of symptoms.

6 ADVERSE REACTIONSAdverse reactions to epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness;dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties.These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likelyto occur in patients with hypertension or hyperthyroidism [see WARNINGS AND PRECAUTIONS (5.4)].Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients withunderlying cardiac disease or those receiving certain drugs [see WARNINGS AND PRECAUTIONS(5.4) and DRUG INTERACTIONS (7)].Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients withcardiovascular disease [see WARNINGS AND PRECAUTIONS (5.4)].Angina may occur in patients with coronary artery disease [see WARNINGS AND PRECAUTIONS(5.4)].Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area[see WARNINGS AND PRECAUTIONS (5.2)].Adverse events experienced as a result of accidental injections may include increased heart rate, localreactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resultingin bruising, bleeding, discoloration, erythema or skeletal injury.7 DRUG INTERACTIONSPatients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see WARNINGSAND PRECAUTIONS (5.4)].The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidaseinhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine,and diphenhydramine.The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergicblocking drugs, such as propranolol.The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergicblocking drugs, such as phentolamine.Ergot alkaloids may also reverse the pressor effects of epinephrine.8 USE IN SPECIFIC POPULATIONS8.1 PREGNANCYTeratogenic Effects: Pregnancy Category C.There are no adequate and well controlled studies of the acute effect of epinephrine in pregnantwomen.Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used duringpregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneousabortion, or both).Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbitsat approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (ona mg/m2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternalsubcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times themaximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternalsubcutaneous dose of 0.5 mg/kg/day for 4 days).These effects were not seen in mice at approximately 3 times the maximum recommended dailysubcutaneous or intramuscular dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5mg/kg/day for 10 days).8.3 NURSING MOTHERSIt is not known whether epinephrine is excreted in human milk. Because many drugs are excreted inhuman milk, caution should be exercised when Auvi-Q™ is administered to a nursing woman.8.4 PEDIATRIC USEAuvi-Q™ may be given safely to pediatric patients at a dosage appropriate to body weight [seeDOSAGE AND ADMINISTRATION (2)]. However, studies in pediatric patients weighing less than 15kg (33 pounds) have not been conducted.8.5 GERIATRIC USEClinical studies of Auvi-Q™ did not include sufficient numbers of subjects aged 65 and over todetermine whether they respond differently from younger subjects. Other reported clinical experiencehas not identified differences in responses between the elderly and younger patients. Epinephrineshould be administered with caution in elderly individuals, who may be at greater risk for developingadverse reactions after epinephrine administration [see WARNINGS AND PRECAUTIONS (5.4),OVERDOSAGE (10)].10 OVERDOSAGEOverdosage of epinephrine may produce extremely elevated arterial pressure, which may result incerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonaryedema because of peripheral vascular constriction together with cardiac stimulation. Treatment consistsof rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these maybe accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions mayappear within one minute after injection and may be followed by multifocal ventricular tachycardia

(prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia andoccasionally by atrioventricular block. Treatment of arrhythmias consists of administration of abeta-adrenergic blocking drug such as propranolol.Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, andkidney failure. Suitable corrective measures must be taken in such situations.11 DESCRIPTIONAuvi-Q™ (epinephrine injection, USP) 0.3 mg and 0.15 mg is an auto-injector and a combinationproduct containing drug and device components.Auvi-Q™ includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use.Each Auvi-Q™ 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP(0.3 mL) in a sterile solution.Each Auvi-Q™ 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP(0.15 mL) in a sterile solution.Auvi-Q™ 0.3 mg and Auvi-Q™ 0.15 mg each contain 0.76 mL epinephrine solution. 0.3 mL and 0.15mL epinephrine solution is dispensed for Auvi-Q™ 0.3 mg and Auvi-Q™ 0.15 mg, respectively, whenactivated. The remaining solution is not available for future use and should be discarded.Each 0.3 mL in Auvi-Q™ 0.3 mg contains 0.3 mg epinephrine, 2.3 mg sodium chloride, 0.5 mg sodiumbisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0.Each 0.15 mL in Auvi-Q™ 0.15 mg contains 0.15 mg epinephrine, 1.2 mg sodium chloride, 0.2 mgsodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0.Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation toadrenochrome and brown from the formation of melanin.Auvi-Q™ is not made with natural rubber latex.Auvi-Q™ instructional and safety systems should be thoroughly reviewed with patients and caregiversprior to use [see PATIENT COUNSELING INFORMATION (17.1)].12 CLINICAL PHARMACOLOGY12.1 MECHANISM OF ACTIONEpinephrine acts on both alpha and beta-adrenergic receptors.12.2 PHARMACODYNAMICSThrough its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increasedvascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluidvolume and hypotension.Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth musclerelaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphy-laxis.Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal andgenitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smoothmuscle of the stomach, intestine, uterus and urinary bladder.When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration ofaction.13 NONCLINICAL TOXICOLOGY13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITYLong-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and tobe an oxidative mutagen in a WP2 bacterial reverse mutation assay.Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenicin the Salmonella bacterial reverse mutation assay.The potential for epinephrine to impair fertility has not been evaluated.This should not prevent the use of epinephrine under the conditions noted under INDICATIONS ANDUSAGE (1).16 HOW SUPPLIED/STORAGE AND HANDLING16.1 HOW SUPPLIEDCarton containing two Auvi-Q™ (epinephrine injection, USP) 0.3 mg auto-injectors and a singleAuvi-Q™ Trainer - NDC 0024-5833-02Carton containing two Auvi-Q™ (epinephrine injection, USP) 0.15 mg auto-injectors and a singleAuvi-Q™ Trainer - NDC 0024-5831-02Rx only16.2 STORAGE AND HANDLINGEpinephrine is light sensitive and should be stored in the outer case provided to protect it from light.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate. Beforeusing, check to make sure the solution in the auto-injector is clear and colorless. Replace theauto-injector if the solution is discolored, cloudy, or contains particles.17 PATIENT COUNSELING INFORMATION[see FDA-Approved Patient Labeling]A healthcare provider should review the patient instructions and operation of Auvi-Q™, in detail, withthe patient or caregiver.Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or with a historyof severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens,as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about thecircumstances under which epinephrine should be used.17.1 ADMINISTRATION AND TRAININGPatients and/or caregivers should be instructed in the appropriate use of Auvi-Q™. Auvi-Q™ shouldbe injected into the middle of the outer thigh (through clothing, if necessary). Each device is a single-useinjection. Advise patients to seek immediate medical care in conjunction with administration of Auvi-Q™.Complete patient information, including dosage, directions for proper administration and precautionscan be found inside each Auvi-Q™ carton. A printed label on the surface of Auvi-Q™ shows instructionsfor use and a diagram depicting the injection process. Auvi-Q™ also emits visual prompts and electronicvoice instructions for use.

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Patients and/or caregivers should be instructed to use the Trainer to familiarize themselves with theuse of Auvi-Q™ in an allergic emergency. The Trainer may be used multiple times.

17.2 ADVERSE REACTIONSEpinephrine may produce symptoms and signs that include an increase in heart rate, the sensationof a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor,dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptomsand signs usually subside rapidly, especially with rest, quiet and recumbency. Patients with hyper-tension or hyperthyroidism may develop more severe or persistent effects, and patients with coronaryartery disease could experience angina. Patients with diabetes may develop increased blood glucoselevels following epinephrine administration. Patients with Parkinson’s disease may notice a temporaryworsening of symptoms [see WARNINGS AND PRECAUTIONS (5.4)].

17.3 ACCIDENTAL INJECTIONPatients should be advised to seek immediate medical care in the case of accidental injection. Sinceepinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment shouldbe directed at vasodilatation if there is such an accidental injection to these areas [see WARNINGSAND PRECAUTIONS (5.2)].

17.4 STORAGE AND HANDLINGPatients should be instructed to inspect the epinephrine solution visually through the viewing windowperiodically. Auvi-Q™ should be replaced if the epinephrine solution appears discolored (pinkish coloror darker than slightly yellow), cloudy, or contains particles. Epinephrine is light sensitive and shouldbe stored in the outer case provided to protect it from light. Patients should be instructed that Auvi-Q™must be used or properly disposed once the red safety guard is removed [see STORAGE ANDHANDLING (16.2)].Complete patient information, including dosage, directions for proper administration and precautionscan be found inside each Auvi-Q™ carton.

INSTRUCTIONS for UseHow to use Auvi-Q™1. Pull Auvi-Q™ from the outer caseDo not proceed to step 2 until you are ready to use Auvi-Q™. If not ready touse, replace the outer case.

2. Pull off Red safety guardTo avoid an accidental injection, never touch the black base of the auto-injector.If an accidental injection does occur, seek medical help immediately.NOTE: The safety guard is meant to be tight. Pull firmly to remove.

3. Place black end against the middle of the outer thigh (through clothing,if necessary), then press firmly and hold in place for 5 seconds. Eachdevice is a single-use injection.Only inject into the middle of the outer thigh (upper leg). Do not inject into anyother location. Note: Auvi-Q™ makes a distinct sound (click and hiss) whenactivated. This is normal and indicates Auvi-Q™ is working correctly. Donot pull Auvi-Q™ away from your leg when you hear the click and hisssound.

4. Seek medical attention immediatelyReplace the outer case and take your used Auvi-Q™ with you to a healthcareprofessional for proper disposal and a prescription refill.AFTER using Auvi-Q™Seek medical attention immediately.With a severe, long-lasting allergic reaction, you may need to administer anadditional Auvi-Q™. More than two sequential doses of epinephrine should onlybe administered under direct medical supervision.Following administration of Auvi-Q™:

- The black base will lock into place.- The voice instruction system will confirm Auvi-Q™ has been used and the

LED lights will blink red.- The red safety guard cannot be replaced.- The viewing window will no longer be clear.- Some medicine will remain in Auvi-Q™. However, the injection is complete

and you have received the correct dose of the medication.- Take to your healthcare provider for proper disposal (never discard Auvi-Q™

in regular trash).*- Discuss your medical history and current medications with the healthcare

professional (for example, diabetic patients may need to adjust the dose oftheir diabetes medicines or insulin after using Auvi-Q™).

Auvi-Q™ and any remaining medicine cannot be reused. Until you dispose ofyour used Auvi-Q™, the interactive instruction system will remind you that it hasbeen used whenever you remove the outer case.General information about the safe and effective use of Auvi-Q™Medicines are sometimes prescribed for conditions that are not mentioned inpatient information leaflets. Do not use Auvi-Q™ for a condition for which it wasnot prescribed.Never give Auvi-Q™ to other people, even if they have the same symptoms youhave.This leaflet summarizes the most important information about Auvi-Q™. If youwould like more information, talk with your Healthcare Provider or Pharmacist.

Revised September 2012Manufactured for:sanofi-aventis U.S. LLCBridgewater, NJ 08807

A SANOFI COMPANY

*For California Only: This product uses batteries containingPerchlorate Material – special handling may apply. Seewww.dtsc.ca.gov/hazardouswaste/perchlorate

EPI-FPLR-SL-SEP12 Rx Only

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the severe allergy & anaphylaxis playbook

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