Auvi-Q 0.1mg 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, Vasopressor
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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 0.1mg is an emergency medicine used to treat severe allergic reactions (anaphylaxis) in infants and small children weighing 16.5 to 33 pounds. It works by quickly opening airways, raising blood pressure, and reducing swelling. It is not a substitute for emergency medical care; always call 911 after using it.
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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 review the package insert and instructions for use that come with this medication. If you have any questions, consult your doctor or pharmacist.

Availability and Accessibility

Keep this medication with you at all times, and consider storing extra devices 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 use it if needed.

Pre-Use Checks

Before using the device, verify that 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.

Administration Technique

To administer the medication:

1. Remove the pen from its case.
2. Hold the pen with the tip facing down.
3. Make a fist around the pen.
4. Remove the safety release and discard it immediately after use, as it may pose a choking hazard if accidentally swallowed by a child or pet.
5. Inject the medication straight into the outer thigh, as instructed. If necessary, the medication can be administered through clothing.
6. Hold the injection in place for the recommended duration.

Important Administration Considerations

Do not inject the medication into the buttocks.
When administering the medication to a child, hold their leg still to prevent injury and try to limit their movement before and during the injection.

Post-Use Procedures

After using the medication:

1. Seek medical help immediately.
2. Return the device to its storage case.
3. Bring the used device with you to the hospital.

Inspection and Replacement

Do not use the medication if the solution has changed color, is cloudy, or contains particles. Obtain a new device in such cases. If the device has expired, get a refill before a dose is needed. If the device has been accidentally activated, do not use it for an emergency; instead, 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 Auvi-Q with you and your child at all times.
  • Know your child's allergy triggers and avoid them.
  • Ensure caregivers, school staff, and family members know how to use Auvi-Q.
  • Check the expiration date regularly and replace before it expires.
  • Store at room temperature (68°F to 77°F or 20°C to 25°C), away from light and extreme temperatures.

Dosing & Administration

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Adult Dosing

Standard Dose: Not indicated for typical adult use; adults typically require 0.3 mg or 0.5 mg formulations.

Condition-Specific Dosing:

anaphylaxis: Administer 0.1 mg intramuscularly into the anterolateral aspect of the thigh. Repeat every 5 to 15 minutes if anaphylaxis symptoms persist or recur. Seek immediate medical attention.
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Pediatric Dosing

Neonatal: Not established
Infant: 0.1 mg for patients weighing 7.5 kg to 15 kg (16.5 lbs to 33 lbs). Administer intramuscularly into the anterolateral aspect of the thigh. Repeat every 5 to 15 minutes if anaphylaxis symptoms persist or recur. Seek immediate medical attention.
Child: 0.1 mg for patients weighing 7.5 kg to 15 kg (16.5 lbs to 33 lbs). For children weighing >15 kg, 0.3 mg formulation is typically used. Administer intramuscularly into the anterolateral aspect of the thigh. Repeat every 5 to 15 minutes if anaphylaxis symptoms persist or recur. Seek immediate medical attention.
Adolescent: Not indicated for typical adolescent use; adolescents typically require 0.3 mg or 0.5 mg formulations.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed
Dialysis: No specific adjustment needed; rapidly metabolized

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed

Pharmacology

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Mechanism of Action

Epinephrine is a non-selective adrenergic agonist, acting on alpha-1, beta-1, and beta-2 adrenergic receptors. Its alpha-1 adrenergic effects cause vasoconstriction, increasing peripheral vascular resistance and blood pressure, and decreasing mucosal edema. Its beta-1 adrenergic effects increase heart rate and myocardial contractility. Its beta-2 adrenergic effects cause bronchodilation and can decrease the release of mediators from mast cells and basophils.
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Pharmacokinetics

Absorption:

Bioavailability: High (after IM injection)
Tmax: Approximately 5-10 minutes (IM)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Not readily quantifiable due to rapid metabolism
ProteinBinding: Approximately 50%
CnssPenetration: Limited

Elimination:

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

OnsetOfAction: Within minutes (IM)
PeakEffect: Approximately 5-10 minutes
DurationOfAction: 10-20 minutes

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help 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, contact your doctor or 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 abnormal 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
Burning, numbness, or tingling sensations that are not normal
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 does not go away
+ Warmth
+ Swelling
+ Tenderness

Other Possible Side Effects

Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not 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, contact 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:

  • Fast or irregular heartbeat
  • Dizziness or lightheadedness
  • Anxiety or nervousness
  • Tremor or shaking
  • Headache
  • Nausea or vomiting
  • Sweating
  • Pallor (paleness)
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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 is not an exhaustive list, and it is crucial to disclose all your medications and health conditions to your doctor and pharmacist.
Any health problems you have, as they may interact with this medication. Your doctor and pharmacist need to be aware of your complete medical profile to ensure safe treatment.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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 high blood sugar (diabetes) should closely monitor their blood sugar levels while taking this drug.

Individuals 65 years or older should exercise caution when using this medication, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypertension (very high blood pressure)
  • Tachycardia (very fast heart rate)
  • Cardiac arrhythmias (irregular heart rhythms)
  • Cerebral hemorrhage (bleeding in the brain)
  • Pulmonary edema (fluid in the lungs)
  • Renal failure

What to Do:

Seek immediate emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive, including alpha-adrenergic blocking agents for severe hypertension and beta-adrenergic blocking agents for arrhythmias, if necessary.

Drug Interactions

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Major Interactions

  • Beta-adrenergic blockers (e.g., propranolol, carvedilol): May antagonize the bronchodilator and vasodilator effects of epinephrine, potentially leading to severe hypertension and reflex bradycardia. May also block the beneficial cardiac effects of epinephrine.
  • Tricyclic antidepressants (TCAs) and Monoamine oxidase inhibitors (MAOIs): May potentiate the pressor effects of epinephrine, leading to severe hypertension and arrhythmias.
  • Digitalis glycosides: Increased risk of cardiac arrhythmias.
  • Alpha-adrenergic blockers (e.g., phentolamine): May antagonize the alpha-adrenergic effects of epinephrine, leading to hypotension and tachycardia.
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Moderate Interactions

  • Antihistamines (e.g., diphenhydramine, chlorpheniramine): Some older antihistamines may potentiate the effects of epinephrine.
  • Diuretics (e.g., loop diuretics, thiazide diuretics): May reduce the pressor response to epinephrine.
  • Ergot alkaloids: May cause additive vasoconstriction.

Monitoring

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Routine Monitoring

Heart Rate

Frequency: Immediately after administration and periodically thereafter

Target: Age-appropriate normal range

Action Threshold: Significant tachycardia or bradycardia

Blood Pressure

Frequency: Immediately after administration and periodically thereafter

Target: Age-appropriate normal range

Action Threshold: Significant hypertension or hypotension

Respiratory Status

Frequency: Continuously

Target: Normal breathing, absence of wheezing/stridor

Action Threshold: Persistent dyspnea, wheezing, stridor, or signs of respiratory distress

Allergic Reaction Symptoms

Frequency: Continuously

Target: Resolution of symptoms (e.g., urticaria, angioedema, gastrointestinal symptoms)

Action Threshold: Persistence or recurrence of anaphylaxis symptoms

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Symptom Monitoring

  • Palpitations
  • Tachycardia
  • Hypertension
  • Anxiety
  • Tremor
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Pallor
  • Sweating

Special Patient Groups

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Pregnancy

Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Anaphylaxis is a life-threatening condition for both mother and fetus, and prompt treatment with epinephrine is critical.

Trimester-Specific Risks:

First Trimester: Risk of fetal hypoxia from maternal hypotension or anaphylaxis is high without treatment. Epinephrine use is generally considered acceptable for life-threatening conditions.
Second Trimester: Risk of fetal hypoxia from maternal hypotension or anaphylaxis is high without treatment. Epinephrine use is generally considered acceptable for life-threatening conditions.
Third Trimester: Risk of fetal hypoxia from maternal hypotension or anaphylaxis is high without treatment. Epinephrine use is generally considered acceptable for life-threatening conditions. May cause uterine contractions, but this is usually outweighed by the benefit of treating anaphylaxis.
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Lactation

Epinephrine is rapidly metabolized and has low oral bioavailability, so infant exposure via breast milk is expected to be minimal. It is generally considered safe for use in breastfeeding mothers for acute, life-threatening conditions like anaphylaxis.

Infant Risk: Low
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Pediatric Use

Auvi-Q 0.1mg is specifically designed and indicated for infants and small children weighing 7.5 kg to 15 kg (16.5 lbs to 33 lbs) who are at risk for or have a history of anaphylaxis. Dosing is weight-based, and higher doses (0.3 mg or 0.5 mg) are used for heavier children and adolescents.

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Geriatric Use

While anaphylaxis can occur at any age, caution should be exercised when administering epinephrine to geriatric patients due to increased sensitivity to adrenergic effects, particularly cardiovascular effects (e.g., hypertension, arrhythmias, myocardial ischemia). However, for life-threatening anaphylaxis, age is not a contraindication to epinephrine use.

Clinical Information

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Clinical Pearls

  • Auvi-Q features voice instructions and an auto-retracting needle, which can be beneficial for ease of use, especially in stressful emergency situations.
  • Always administer into the anterolateral aspect of the thigh, through clothing if necessary. Never inject into a vein, buttocks, fingers, toes, hands, or feet.
  • After administering Auvi-Q, always seek immediate emergency medical attention (call 911) as anaphylaxis can be biphasic (recur) or require additional treatment.
  • The 0.1 mg dose is specifically for very young children; ensure the correct dose is prescribed and available based on the patient's weight.
  • Check the viewing window on the auto-injector after use to ensure the red plunger is visible, indicating the dose has been delivered.
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Alternative Therapies

  • H1-antihistamines (e.g., diphenhydramine, cetirizine) - adjunctive, not primary treatment for anaphylaxis
  • H2-antihistamines (e.g., ranitidine, famotidine) - adjunctive, not primary treatment for anaphylaxis
  • Corticosteroids (e.g., prednisone, methylprednisolone) - adjunctive, for preventing protracted or biphasic reactions, not primary treatment for acute anaphylaxis
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Cost & Coverage

Average Cost: $400 - $550 per 2 auto-injectors
Insurance Coverage: Tier 2 or 3 (Specialty/Non-preferred Brand)
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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.