Auvi-Q 0.3mg Inj, 2 Auto Injectors

Manufacturer KALEO Active Ingredient Epinephrine Auto-Injector and Prefilled Syringe(ep i NEF rin) Pronunciation EP-i-NEF-rin
It is used to treat an allergic reaction.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anaphylaxis treatment
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Pharmacologic Class
Alpha- and Beta-adrenergic Agonist
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Pregnancy Category
C
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FDA Approved
Aug 2012
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Auvi-Q is an auto-injector containing epinephrine, a medicine used to treat life-threatening allergic reactions (anaphylaxis). It works quickly to open airways, raise blood pressure, and reduce swelling. It's designed for immediate use by patients or caregivers at the first sign of a severe allergic reaction.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into a muscle or the fatty part of the skin. It's essential to understand how to use it before an emergency situation arises. Carefully read the package insert and instructions for use that come with this medication. If you have any questions, consult your doctor or pharmacist.

Carrying and Storing the Medication

Keep this medication with you at all times, and consider storing extra doses at work, school, and home in case someone else needs to administer it. Ensure that others know where the medication is stored and how to administer it if needed.

Preparing the Device for Use

Before using the device, check to ensure the safety release is in place and that the device can be removed from its case. Do not remove the safety release until you are ready to use the medication. When ready, remove the pen from its case, holding it with the tip down. Make a fist around the pen and pull off the safety release. Immediately discard the safety release after use, as it may pose a choking hazard if accidentally swallowed by a child or pet.

Administering the Medication

Inject the medication straight into the outer thigh, as instructed. If necessary, the medication can be administered through clothing. Hold the injection in place for the recommended duration. Avoid injecting into the buttocks. If administering the medication to a child, hold their leg still to prevent injury and try to limit their movement before and during the injection.

After Administration

Seek medical help immediately after using this medication. Return the device to its storage case and take it with you to the hospital.

Inspecting the Medication

Do not use the medication if the solution has changed color, is cloudy, or contains particles. Obtain a new dose instead. If the medication has expired, get a refill before it is needed. If the device has been accidentally activated, do not use it for an emergency; replace it with a new one.

Storage and Disposal

Store the medication at room temperature, avoiding refrigeration or freezing.

Missed Dose

If you miss a dose, seek medical help immediately.
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Lifestyle & Tips

  • Always carry two Auvi-Q auto-injectors with you at all times.
  • Avoid known allergens.
  • Educate family, friends, and caregivers on how to recognize anaphylaxis and administer Auvi-Q.
  • Check the expiration date regularly and replace before it expires.
  • Store at room temperature, away from light and extreme heat or cold.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.3 mg intramuscularly (IM) into the anterolateral aspect of the thigh, may repeat every 5-15 minutes if anaphylactic symptoms persist or recur.
Dose Range: 0.3 - 0.3 mg

Condition-Specific Dosing:

anaphylaxis: 0.3 mg IM, repeat as needed
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (Auvi-Q 0.1 mg or 0.15 mg may be used for infants/children weighing 7.5 kg to <15 kg or 15 kg to <30 kg respectively)
Child: Auvi-Q 0.3 mg is generally for children weighing 30 kg (66 lbs) or more. For children weighing 15 kg to <30 kg, Auvi-Q 0.15 mg is used. For children weighing 7.5 kg to <15 kg, Auvi-Q 0.1 mg is used.
Adolescent: 0.3 mg intramuscularly (IM) into the anterolateral aspect of the thigh, may repeat every 5-15 minutes if anaphylactic symptoms persist or recur.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for acute, life-saving use.
Moderate: No specific adjustment needed for acute, life-saving use.
Severe: No specific adjustment needed for acute, life-saving use.
Dialysis: No specific adjustment needed for acute, life-saving use.

Hepatic Impairment:

Mild: No specific adjustment needed for acute, life-saving use.
Moderate: No specific adjustment needed for acute, life-saving use.
Severe: No specific adjustment needed for acute, life-saving use.

Pharmacology

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Mechanism of Action

Epinephrine is a non-selective alpha- and beta-adrenergic receptor agonist. Its alpha-adrenergic effects (vasoconstriction) counteract vasodilation and increased vascular permeability, which can lead to loss of intravascular fluid volume and hypotension. Its beta-adrenergic effects (bronchodilation, positive inotropic and chronotropic effects) relieve bronchospasm, increase heart rate and contractility, and suppress the release of mediators from mast cells and basophils.
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Pharmacokinetics

Absorption:

Bioavailability: Rapid and complete after IM injection
Tmax: Approximately 5-10 minutes after IM injection
FoodEffect: Not applicable (IM administration)

Distribution:

Vd: Not readily quantifiable due to rapid metabolism
ProteinBinding: Not applicable
CnssPenetration: Limited (does not readily cross the blood-brain barrier)

Elimination:

HalfLife: Approximately 2-3 minutes (very short)
Clearance: Very rapid
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes)
PeakEffect: Within 5-10 minutes
DurationOfAction: Short (effects subside within minutes)

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Rapid heartbeat
Shortness of breath
Difficulty urinating or changes in urine output
Unusual burning, numbness, or tingling sensations
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Abnormal heartbeat (which can be life-threatening, especially if you have pre-existing heart problems or take certain medications)
Signs of infection at the injection site, such as:
+ Redness that doesn't go away
+ Warmth
+ Swelling
+ Tenderness

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor if they bother you or don't go away:

Feeling anxious, nervous, excitable, shaky, or restless
Upset stomach or vomiting
Excessive sweating
Pale skin
Headache
Dizziness, tiredness, or weakness
Goosebumps

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Difficulty breathing, wheezing, shortness of breath
  • Hives, itching, flushing, swelling of face, lips, tongue, or throat
  • Dizziness, fainting, rapid or weak pulse, low blood pressure
  • Nausea, vomiting, diarrhea, abdominal cramps
  • Feeling of impending doom
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as they may affect the safety and efficacy of this medication.

Remember, this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health conditions before taking this drug. Never start, stop, or change the dose of any medication without first discussing it with your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When administering this drug, avoid injecting it into the fingers, hands, or feet, as this may cause reduced blood flow to these areas. If accidental injection occurs, seek immediate medical attention.

If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites.

Patients with diabetes (high blood sugar) should closely monitor their blood sugar levels while taking this drug.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypertension (high blood pressure)
  • Tachycardia (rapid heart rate)
  • Arrhythmias (irregular heartbeats)
  • Cerebral hemorrhage (bleeding in the brain)
  • Pulmonary edema (fluid in the lungs)
  • Anxiety, restlessness, tremor, headache, pallor

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including alpha-blockers for severe hypertension and beta-blockers for arrhythmias.

Drug Interactions

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Major Interactions

  • Beta-adrenergic blockers (non-selective)
  • Alpha-adrenergic blockers
  • Tricyclic antidepressants (TCAs)
  • Monoamine oxidase inhibitors (MAOIs)
  • Catechol-O-methyltransferase (COMT) inhibitors
  • Digitalis glycosides
  • Diuretics (e.g., loop or thiazide diuretics)
  • Antihistamines (e.g., diphenhydramine, chlorpheniramine)
  • Thyroid hormones
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Moderate Interactions

  • Antipsychotics (e.g., phenothiazines)
  • Oxytocic drugs

Monitoring

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Symptom Monitoring

  • Resolution of anaphylactic symptoms (e.g., difficulty breathing, wheezing, hives, swelling, dizziness, rapid pulse, severe anxiety)
  • Recurrence of symptoms (indicating need for repeat dose)
  • Adverse effects (e.g., palpitations, tachycardia, anxiety, tremor, headache, pallor, dizziness)

Special Patient Groups

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Pregnancy

Epinephrine is the drug of choice for anaphylaxis during pregnancy. Untreated anaphylaxis poses a greater risk to both mother and fetus than potential adverse effects of epinephrine. Use only when clearly indicated for life-threatening conditions.

Trimester-Specific Risks:

First Trimester: Risk of fetal hypoxia from maternal hypotension/anaphylaxis is high if untreated. Epinephrine use is justified.
Second Trimester: Risk of fetal hypoxia from maternal hypotension/anaphylaxis is high if untreated. Epinephrine use is justified.
Third Trimester: Risk of fetal hypoxia from maternal hypotension/anaphylaxis is high if untreated. Epinephrine use is justified. May cause uterine contractions, but this is secondary to the life-saving need.
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Lactation

Epinephrine is naturally occurring and rapidly metabolized. It is considered compatible with breastfeeding when used for acute, life-threatening conditions. Minimal amounts are expected to be transferred into breast milk.

Infant Risk: Low risk to breastfed infant due to rapid metabolism and low oral bioavailability.
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Pediatric Use

Dosing is weight-based. Auvi-Q 0.3 mg is for patients weighing 30 kg (66 lbs) or more. Smaller doses (0.1 mg or 0.15 mg) are available for lighter children. Proper training for caregivers is crucial.

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Geriatric Use

Use with caution in elderly patients, especially those with pre-existing cardiovascular disease, hypertension, or diabetes, due to increased risk of adverse cardiovascular effects. However, age is not a contraindication for life-saving treatment of anaphylaxis.

Clinical Information

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Clinical Pearls

  • Always carry two auto-injectors in case the first dose is insufficient or symptoms recur.
  • Administer into the anterolateral aspect of the thigh, through clothing if necessary. Avoid injection into buttocks, hands, or feet.
  • After administering Auvi-Q, always seek immediate medical attention, even if symptoms improve, as biphasic reactions can occur.
  • Familiarize yourself and caregivers with the voice instructions and visual cues provided by Auvi-Q.
  • Check the expiration date regularly and replace the device before it expires. Many manufacturers offer reminders or replacement programs.
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Alternative Therapies

  • EpiPen (epinephrine auto-injector)
  • Adrenaclick (epinephrine auto-injector)
  • Symjepi (epinephrine pre-filled syringe)
  • Manual epinephrine injection (e.g., from ampule/vial for healthcare professionals)
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Cost & Coverage

Average Cost: $400 - $600+ per 2 auto-injectors
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization or step therapy)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.