EPINEPHRINE

EPINEPHRINE- epinephrine injection, solution
HF Acquisition Co LLC, DBA HealthFirst

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

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: 9/2019

TABLE OF CONTENTS

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
8.2 LACTATION
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.

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.

2 DOSAGE & ADMINISTRATION

Selection of the appropriate dosage strength (AUVI-Q 0.3 mg, AUVI-Q 0.15 mg or AUVI-Q 0.1 mg) is determined according 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 to 66 pounds): AUVI-Q 0.15 mg
Patients 7.5 to 15 kg (16.5 to 33 pounds): AUVI-Q 0.1 mg

Inject AUVI-Q intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children and infants who are prescribed AUVI-Q and who may be uncooperative and kick or move during an injection to hold the child’s leg firmly in place and limit movement prior to and during an injection [see WARNINGS AND PRECAUTIONS ( 5-5.2)].

Each AUVI-Q contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from AUVI-Q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional AUVI-Q may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see WARNINGS AND PRECAUTIONS ( 5-5.1)].

The epinephrine solution in the viewing window of AUVI-Q should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see STORAGE AND HANDLING ( 16-16.2)].

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