PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel, Trainer Labeling (2) Included With 51662-1320-2 &

51662-1321-2

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CLINICAL PHARMACOLOGY SECTION

12 CLINICAL PHARMACOLOGY

12.1 MECHANISM OF ACTION

Epinephrine acts on both alpha and beta-adrenergic receptors.

12.2 PHARMACODYNAMICS

Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.

Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.

Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

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INDICATIONS & USAGE SECTION

1 INDICATIONS & USAGE

AUVI-Q® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire 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 idiopathic anaphylaxis or exercise-induced anaphylaxis.

AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk 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 to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care.

DOSAGE FORMS & STRENGTHS SECTION

3 DOSAGE FORMS & 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
Injection, 0.1 mg/0.1 mL epinephrine injection, USP, pre-filled auto-injector

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CONTRAINDICATIONS SECTION

4 CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS SECTION

5 WARNINGS AND PRECAUTIONS

5.1 EMERGENCY TREATMENT

AUVI-Q is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see INDICATIONS AND USAGE ( 1), DOSAGE AND ADMINISTRATION (2) and PATIENT COUNSELING INFORMATION 17-(17.1)].

5.2 INJECTION-RELATED COMPLICATIONS

AUVI-Q should ONLY be injected into the anterolateral aspect of the thigh [see DOSAGE AND ADMINISTRATION (2) and PATIENT COUNSELING INFORMATION 17-(17.1)].

Do not inject intravenously. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract 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 of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower this risk.
Do not inject into digits, hands or feet. Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see ADVERSE REACTIONS ( 6)].
Hold leg firmly during injection. To minimize the risk of injection-related injury when administering AUVI-Q to young children or infants, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

5.3 SERIOUS INFECTIONS AT THE INJECTION SITE

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce the presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the potential risk of a rare, but serious Clostridium infection, do not inject AUVI-Q into the buttock [see WARNINGS AND PRECAUTIONS (5.2)]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.

5.4 ALLERGIC REACTIONS ASSOCIATED WITH SULFITE

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.

The presence of a sulfite in this product should not deter administration of the drug for treatment of serious 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.

5.5 DISEASE INTERACTIONS

Some 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 a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer AUVI-Q to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.

Patients with Heart Disease

Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such 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 ventricular arrhythmias [see DRUG INTERACTIONS ( 7) and ADVERSE REACTIONS ( 6)].

Other Patients and Diseases

Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.

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DRUG INTERACTIONS SECTION

7 DRUG INTERACTIONS

Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see WARNINGS AND PRECAUTIONS 5-(5.5)].

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol.

The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine.

Ergot alkaloids may also reverse the pressor effects of epinephrine.

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OVERDOSAGE SECTION

10 OVERDOSAGE

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear 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 and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

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NONCLINICAL TOXICOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-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 to be 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 mutagenic in 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 AND USAGE (1).

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INFORMATION FOR PATIENTS SECTION

PATIENT INFORMATION/INSTRUCTIONS FOR USE

AUVI-Q® (epinephrine injection)
Auto-Injector
For allergic emergencies (anaphylaxis)

Read this Patient Information Leaflet before you have to use AUVI-Q and each time you get a refill. There may be new information. You should know how to use AUVI-Q before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about AUVI-Q?

Always carry AUVI-Q with you because you may not know when a life-threatening allergic reaction (anaphylactic reaction) may happen. Talk to your doctor if you need additional units to keep at work, school, etc. An anaphylactic reaction is a life-threatening allergic reaction that can happen within minutes and can be caused by stinging and biting insects (bees, wasps, hornets, and mosquitoes), allergy shots, foods, medicines, exercise, or other unknown causes. Follow your healthcare provider’s instructions on when to use AUVI-Q if you have the symptoms of an anaphylactic reaction, which may include the symptoms listed below:

trouble breathing
wheezing
hoarseness (changes in the way your voice sounds)
hives (raised reddened rash that may itch)
severe itching
swelling of your face, lips, mouth or tongue
skin rash, redness, or swelling
fast heartbeat
weak pulse
feeling very anxious
confusion
stomach pain
losing control of urine or bowel movements
dizziness or fainting

Tell your family members and others where you keep AUVI-Q and how to use it before you need it. You may be unable to speak in an allergic emergency.
Get medical attention immediately after using AUVI-Q. If you have a serious allergic reaction, you may need more medicine.

What is AUVI-Q?

AUVI-Q is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in people who are at risk for or have a history of serious allergic reactions.

AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using AUVI-Q.

It is not known if AUVI-Q is safe and effective in children who weigh less than 16.5 pounds (7.5 kg).

What should I tell my healthcare provider before using AUVI-Q?
Before you use AUVI-Q, tell your healthcare provider if you:

have heart problems or high blood pressure
have diabetes
have thyroid problems
have history of depression
have Parkinson’s disease
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if AUVI-Q will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if AUVI-Q passes into your breast milk.

Tell your healthcare provider about all the medicines you take,
including prescription and non-prescription medicines, vitamins, and herbal supplements.

AUVI-Q and other medicines may affect each other, causing side effects. AUVI-Q may affect the way other medicines work, and other medicines may affect how AUVI-Q works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use AUVI-Q?

Each AUVI-Q contains only 1 dose of medicine.
AUVI-Q should only be injected into the muscle of your outer thigh. It can be injected through your clothing, if needed.
Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use AUVI-Q.
Use AUVI-Q exactly as your healthcare provider tells you to use it.
A Trainer for AUVI-Q with a separate Trainer Instructions for Use leaflet is included with AUVI-Q. Additional training resources are available at www.auvi-q.com.

Practice with the Trainer for AUVI-Q before an allergic emergency happens to make sure you are able to safely use the real AUVI-Q in an emergency.
The Trainer for AUVI-Q does not contain a needle or medicine and can be reused to practice your injection.

What are the possible side effects of AUVI-Q?

AUVI-Q may cause serious side effects.

AUVI-Q should only be injected into your outer thigh. Do not inject AUVI-Q into your:

veins
buttocks
fingers, toes, hands or feet

If you accidentally inject AUVI-Q into any other part of your body, go to the nearest hospital emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:

redness that does not go away
swelling
tenderness
the area feels warm to the touch

If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child or infant during an injection.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Talk to your healthcare provider about all your medical conditions.

Common side effects of AUVI-Q include:

fast, irregular, or ‘pounding’ heart beat
sweating
shakiness
headache
paleness
feelings of over excitement, nervousness, or anxiety
weakness
dizziness
nausea and vomiting
breathing problems

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of AUVI-Q. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store AUVI-Q?

Store AUVI-Q at 68° to 77°F (20° to 25°C).
Do NOT expose to extreme heat or cold. For example, do NOT store in your vehicle’s glove box. Do not store AUVI-Q in the refrigerator or freeze.
Examine contents in the viewing window periodically. Solution should be clear. If the solution is discolored (pinkish color or darker than slightly yellow), cloudy or contains solid particles, replace the unit.
Your AUVI-Q has an expiration date. Replace it before the expiration date.
Keep AUVI-Q in the outer case it comes in to protect it from light.

Keep AUVI-Q and all medicines out of the reach of children.

General information about the safe and effective use of AUVI-Q:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use AUVI-Q for a condition for which it was not prescribed. Do not give AUVI-Q to other people, even if they have an allergic reaction or the same symptoms that you have. It may harm them.

This Patient Information Leaflet summarizes the most important information about AUVI-Q. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AUVI-Q that is written for health professionals.

For more information and video instructions on the use of AUVI-Q, go to www.auvi-q.com or call 1-844-828-8472.

What are the ingredients in AUVI-Q?
Active ingredient: epinephrine.
Inactive Ingredients: sodium chloride, sodium bisulfite, hydrochloric acid, and water.

AUVI-Q does not contain latex.

Instructions for Use

Read these Instructions for Use carefully before you need to use your AUVI-Q. Before you use AUVI-Q, make sure your healthcare provider shows you the right way to use it. If you have any questions, ask your healthcare provider.

If you are administering AUVI-Q to a young child or infant, hold the leg firmly in place and limit movement prior to and while administering an injection.

Automated Voice Instructions

AUVI-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for any reason, use AUVI-Q as instructed in these Instructions for Use. It will still work during an allergic reaction emergency.

How to use your AUVI-Q

Figure A.

1. Pull AUVI-Q up from the outer case. See Figure B.
Do not go to step 2 until you are ready to use AUVI-Q. If you are not ready to use AUVI-Q, put it back in the outer case.

Figure B.

2. Pull Red safety guard down and off of AUVI-Q. See Figure C.
To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away.

Note: The red safety guard is made to fit tight. Pull firmly to remove.

Figure C.

3. Place black end of AUVI-Q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. See Figure D.

Only inject into the middle of the outer thigh. Do not inject into any other part of the body.

If you are administering AUVI-Q to a young child or infant, hold the leg firmly in place while administering an injection See Figure E.

Figure D.

(For AUVI-Q 0.3 mg and AUVI-Q 0.15 mg)

Figure E.

(For AUVI-Q 0.1 mg)

Note: AUVI-Q makes a distinct sound (click and hiss) when you push it against your outer thigh. This is normal and indicates AUVI-Q is working correctly. Do not pull AUVI-Q away from your leg when you hear the click and hiss sound.

The needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. AUVI-Q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete, and to seek emergency medical attention, AUVI-Q will beep, and the lights will blink red.

4. Get emergency medical help right away.

Replace the outer case and talk to your healthcare provider about the right way to throw away your AUVI-Q.

Ask your healthcare provider for an AUVI-Q prescription refill.
After the use of AUVI-Q:

The black base will lock into place.
The voice instruction system will say “seek emergency medical attention”, say “this AUVI-Q has been used…”, and the lights will blink red.
The red safety guard cannot be replaced.
The viewing window will no longer be clear.
It is normal for some medicine to remain in your AUVI-Q after you have received your dose of medicine.
Talk to your healthcare provider about the right way to throw away your AUVI-Q.
AUVI-Q is a single-use auto-injector and cannot be reused.

Until you throw away your used AUVI-Q, the electronic voice instruction system will remind you that it has been used when the outer case is removed.

If you will be administering AUVI-Q to a young child or infant, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Rev Nov 2017

Manufactured for:
Kaleo, Inc.
Richmond, VA 23219 USA
This product may be covered by one or more U.S. patents or pending patent applications. See www.kaleopharma.com/pat for details.

*For California Only: This product uses batteries containing Perchlorate Material – special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

AUVI-Q(R) EPINEPHRINE INJECTION, USP is supplied in the following dosage forms.

NDC 51662-1320-1

AUVI-Q(R) EPINEPHRINE INJECTION, USP 0.3mg AUTO INJECTOR

NDC 51662-1320-2
AUVI-Q(R) EPINEPHRINE INJECTION, USP 0.3mg 2PK AUTO INJECTOR

NDC 51662-1321-1

AUVI-Q(R) EPINEPHRINE INJECTION, USP 0.15mg AUTO INJECTOR

NDC 51662-1321-2

AUVI-Q(R) EPINEPHRINE INJECTION, USP 0.15mg 2PK AUTO INJECTOR

HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

16.1 HOW SUPPLIED

Carton containing two AUVI-Q (epinephrine injection, USP) 0.3 mg auto- injectors and a single AUVI-Q Trainer - NDC 60842-023-01

Carton containing two AUVI-Q (epinephrine injection, USP) 0.15 mg auto- injectors and a single AUVI-Q Trainer - NDC 60842-022-01

Carton containing two AUVI-Q (epinephrine injection, USP) 0.1 mg auto- injectors and a single AUVI-Q Trainer - NDC 60842-021-01

Rx only

16.2 STORAGE AND HANDLING

Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light. Store at 20°to 25°C (68°to 77°F); excursions permitted to 15°to 30°C (59°to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto- injector is clear and colorless. Replace the auto-injector if the solution is discolored, cloudy, or contains particles.

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INSTRUCTIONS FOR USE SECTION

TRAINER FOR AUVI-Q® Trainer Instructions for Use

Important:
The TRAINER for AUVI-Q Does Not contain a needle or medicine.

In case of an allergic emergency, use the real AUVI-Q and not the gray Trainer.
Always carry your real Auvi-Q with you in case of an allergic emergency.

Important Information about the TRAINER for AUVI-Q:

Inside your TRAINER for AUVI-Q are:

batteries
a speaker that will make a beeping sound and that produces electronic voice instructions
red and green blinking lights

The TRAINER for AUVI-Q batteries are made to last long enough for you to practice 1 time each day for 2 years. If your TRAINER for AUVI-Q does not work properly call your healthcare provider for a new Trainer.

Storage:

Store the TRAINER for AUVI-Q at room temperature; the TRAINER for AUVI-Q should not be used at temperatures less than 50°F (10°C) or greater than 104°F (40°C).
Store the TRAINER for AUVI-Q in its outer case.
Keep the TRAINER for AUVI-Q away from dirt, chemicals, and water.

Disposal:
The TRAINER for AUVI-Q contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. Follow your State and local environmental regulations for disposal.

For California Only: This product uses batteries containing Perchlorate Material - special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate

Manufactured for:
Kaleo, Inc.
Richmond, VA 23219 USA

This product may be covered by one or more U.S. patents or pending patent applications. See www.kaleopharma.com/pat for details.

Rev Nov 2017

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SPL UNCLASSIFIED SECTION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use AUVI-Q® safely and effectively. See full prescribing information for AUVI-Q.

AUVI-Q® (epinephrine injection, USP) 0.3 mg, 0.15 mg, 0.1 mg
Auto-Injector, for intramuscular or subcutaneous use

Initial U.S. Approval: 1939

RECENT MAJOR CHANGES

Dosage and Administration ( 2) 11/2017

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 to 66 lbs): AUVI-Q 0.15 mg ( 2)
Patients 7.5 to 15 kg (16.5 to 33 lbs): AUVI-Q 0.1 mg ( 2)

Inject AUVI-Q intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing 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)
Injection, 0.1 mg: 0.1 mg/0.1 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-(5.1)
Do not inject intravenously, into buttock, or into digits, hands, or feet. 5-(5.2)
To minimize the risk of injection-related injury, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection when administering to young children or infants. 5-(5.2)
Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop signs or symptoms of infection at the epinephrine injection site. 5-(5.3)
The presence of a sulfite in this product should not deter use. 5-(5.4)
Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. 5-(5.5)

ADVERSE REACTIONS

Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact kaleo, Inc. at 1-844-828-8472 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-(5.5), 8(8.5)

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

Revised: 11/2017

SPL INDEXING DATA ELEMENTS SECTION

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 INJECTION-RELATED COMPLICATIONS
5.3 SERIOUS INFECTIONS AT THE INJECTION SITE
5.4 ALLERGIC REACTIONS ASSOCIATED WITH SULFITE
5.5 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

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

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