Auvi-Q

Auvi-Q (epinephrine injection, USP) 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.

Auvi-Q includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use. The needle automatically retracts after the injection is complete.

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 0.15 mL epinephrine solution is dispensed for Auvi-Q 0.3 mg and Auvi-Q 0.15 mg, respectively, when activated. 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 sodium bisulfite, 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 mg sodium 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 to adrenochrome 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 caregivers prior to use [see PATIENT INFORMATION].

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

Storage And Handling

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

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.

Manufactured for: Kaleo, Inc. Richmond, VA 23219 USA. Revised: May 2016

• Sanofi-Aventis U.S. LLC

Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction. After the injection you will need to receive further treatment and observation.

Before using epinephrine, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

To make sure epinephrine injection is safe for you, tell your doctor if you have:

• heart disease or high blood pressure;

• asthma;

• Parkinson's disease;

• depression or mental illness;

• a thyroid or adrenal gland disorder; or

• diabetes (you may need to adjust your dose of insulin or other diabetes medication after using epinephrine injection).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether epinephrine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

In the U.S.

• Adrenaclick
• Adrenalin
• Adrenalin Chloride
• Auvi-Q
• Epipen
• Epipen Jr
• Symjepi
• Twinject

Available Dosage Forms:

• Injectable
• Solution

Therapeutic Class: Anaphylaxis Agent

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

This medicine is available only with your doctor's prescription.

None.

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.

1. 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
2. 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.
3. Get medical attention immediately after using Auvi-Q. If you have a serious allergic reaction, you may need more medicine.

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.

Active ingredient: epinephrine.

Inactive Ingredients: sodium chloride, sodium bisulfite, hydrochloric acid, and water.

Auvi-Q does not contain latex.

Applies to epinephrine: compounding powder, inhalation aerosol, inhalation solution, injectable kit, injectable solution, intravenous solution, subcutaneous suspension

General

Due to the lack of randomized, controlled clinical trials for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of this drug is difficult to determine. The most commonly reported adverse reactions include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.[Ref]

Cardiovascular

Frequency not reported: Tachycardia, supraventricular tachycardia, ventricular arrhythmias, myocardial ischemia, myocardial infarction, limb/peripheral ischemia, palpitations, angina, arrhythmias, hypertension, vasoconstriction, ventricular ectopy, ventricular fibrillation, cold extremities, electrocardiogram changes, stress cardiomyopathy[Ref]

Nervous system

Frequency not reported: Headache, paresthesia, tremor, stroke, central nervous system bleeding, dizziness, cerebral hemorrhage, memory impaired, lightheadedness, psychomotor agitation, tingling, Parkinsonism aggravated, syncope, convulsions, subarachnoid hemorrhage, hemiplegia[Ref]

Psychiatric

Frequency not reported: Nervousness, excitability, anxiety, apprehension, restlessness, disorientation, panic, hallucinations, psychosis, fear, sleeplessness/insomnia, tenseness, confusion, irritability[Ref]

Local

Frequency not reported: Extravasation, injection site pallor, coldness at injection site, hypoesthesia at injection site, injury at injection site, local ischemic necrosis[Ref]

Dermatologic

Frequency not reported: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation, necrotizing fasciitis, flushing/redness of skin and face, hyperhidrosis[Ref]

Metabolic

Frequency not reported: Hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis, insulin secretion inhibited, metabolic acidosis, anorexia[Ref]

Respiratory

Frequency not reported: Pulmonary edema, rales, respiratory difficulty, dyspnea, bronchospasm, hypoxia of mucosa[Ref]

Renal

Frequency not reported: Renal insufficiency[Ref]

Hypersensitivity

Hypersensitivity side effects have been extremely unusual. Contact dermatitis has been associated with ocularly applied epinephrine (the active ingredient contained in Auvi-Q) These reactions have typically presented with lid edema and a thick yellow discharge.

Gastrointestinal

Frequency not reported: Nausea, vomiting, bowel necrosis, hypersalivation[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficult micturition[Ref]

Hematologic

Frequency not reported: Thrombocytosis[Ref]

Musculoskeletal

Frequency not reported: Myonecrosis[Ref]

Other

Frequency not reported: Chest pain, weakness, gas gangrene, asthenia[Ref]

Ocular

Frequency not reported: Corneal endothelial damage[Ref]

Endocrine

Frequency not reported: Growth hormone secretion stimulated[Ref]

Some side effects of Auvi-Q may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.