Auvi-Q

Emergency Allergic Reactions

Auvi-Q is prescribed for the emergency treatment of severe allergic reactions (anaphylaxis). These reactions can be life-threatening and require immediate medical attention. The medication works to quickly reverse symptoms such as swelling of the throat, difficulty breathing, and dangerously low blood pressure.

Common Triggers

This medication is used when a person is exposed to specific triggers that cause a severe reaction, including:

• Foods: Such as peanuts, tree nuts, shellfish, eggs, and milk.
• Insect stings or bites: From bees, wasps, hornets, yellow jackets, and fire ants.
• Medications: Including certain antibiotics or other prescription and non-prescription drugs.
• Latex: Exposure to natural rubber latex products.
• Other allergens: Such as diagnostic testing substances or environmental factors.

Other Uses

Auvi-Q may also be used to treat anaphylaxis caused by physical exertion (exercise-induced anaphylaxis) or cases where the cause of the reaction is unknown (idiopathic anaphylaxis). It is intended for immediate administration by a patient or caregiver at the first sign of a severe allergic reaction while waiting for emergency medical services to arrive.

Mechanism of Action

Auvi-Q delivers epinephrine, which is a synthetic version of the hormone adrenaline. During a severe allergic reaction, also known as anaphylaxis, the body releases chemicals that cause the airways to tighten and blood pressure to drop dangerously low. Epinephrine works by acting on specific receptors throughout the body to counteract these effects.

Effects on the Body

When injected, the medication performs several critical functions to stabilize the patient during an emergency:

• Improving Breathing: It relaxes the muscles in the lungs and airways, allowing them to open up so the person can breathe more easily.
• Raising Blood Pressure: It causes the blood vessels to constrict or narrow. This helps increase blood pressure and reduces the swelling that often occurs in the face, lips, and throat during an allergic reaction.
• Supporting the Heart: It stimulates the heart to beat faster and with more force, which helps maintain blood flow to vital organs.
• Blocking Chemical Release: It helps prevent the further release of histamine and other chemicals that trigger the allergic response.

Because the effects of epinephrine are temporary, it is used as an emergency treatment to provide enough time for the person to receive further medical care at a hospital.

Common Side Effects

Many people experience mild side effects after using an epinephrine injection. These symptoms usually go away quickly with rest. Common side effects include:

• Fast, pounding, or irregular heartbeat
• Nervousness, anxiety, or restlessness
• Tremors or shaking hands
• Dizziness or lightheadedness
• Headache
• Nausea or vomiting
• Sweating
• Pale skin
• Weakness
• Shortness of breath

Serious Side Effects

While epinephrine is used for life-threatening emergencies, some side effects require immediate medical follow-up. Seek help if you experience:

• Chest pain
• Fainting or loss of consciousness
• Seizures
• Sudden vision changes
• Severe headache or confusion
• Signs of infection at the injection site, such as persistent redness, swelling, warmth, or tenderness

If the medication is accidentally injected into the fingers, hands, toes, or feet, seek emergency medical treatment immediately. This can cause a sudden loss of blood flow to the area, resulting in numbness or skin that feels cold to the touch.

Emergency Medical Care

Auvi-Q is intended for immediate self-administration as emergency supportive therapy only. It is not a substitute for professional medical care. After using the device, immediate medical attention is necessary to monitor the reaction and provide further treatment if needed.

Injection Site Precautions

The device must be injected only into the middle of the outer thigh. It should not be injected into the following areas:

• Veins: Accidental injection into a vein may cause a sudden rise in blood pressure or heart rhythm issues.
• Buttocks: Injection into the buttocks may not work as effectively for treating a severe allergic reaction.
• Hands, Feet, or Fingers: Accidental injection into these areas can cause a severe decrease in blood flow, potentially leading to tissue damage. If this occurs, seek emergency treatment immediately.

Risk of Infection

Rare but serious skin and soft tissue infections have been reported at the site of epinephrine injections. To reduce this risk, do not inject the device into the same area repeatedly. Seek medical help if the injection site develops persistent redness, warmth, swelling, or tenderness.

Pre-existing Medical Conditions

Epinephrine should be used with caution in individuals with certain health conditions, including:

• Heart disease or irregular heartbeat
• High blood pressure
• Diabetes
• Thyroid disorders
• Parkinson's disease

Despite these conditions, epinephrine is the primary treatment for life-threatening anaphylaxis and should be used as directed during an emergency.

Sulfite Sensitivity

Auvi-Q contains sodium bisulfite, which can cause allergic-type reactions in some people. However, the presence of sulfites should not prevent the use of the medication for a life-threatening allergic reaction, even in patients who are sensitive to sulfites.

Pregnancy

Epinephrine is considered the first-line treatment for anaphylaxis, a life-threatening allergic reaction, in pregnant individuals. Anaphylaxis is a medical emergency that can cause a dangerous drop in blood pressure and reduce oxygen supply to the fetus. Because of these life-threatening risks, the benefits of using epinephrine in an emergency generally outweigh the potential risks to the pregnancy.

There are no adequate or well-controlled clinical studies on the use of epinephrine in pregnant humans. However, medical professionals prioritize treating the severe allergic reaction to protect both the parent and the fetus.

Breastfeeding

It is not known whether epinephrine passes into breast milk. Since many medications can be excreted in human milk, individuals who are breastfeeding should consult their healthcare provider about the use of this medication. If you are breastfeeding or planning to breastfeed, discuss your emergency allergy treatment plan with your doctor.

Available Forms

Auvi-Q is provided as a pre-filled auto-injector. This device is designed for a single use and delivers the medication through an automatic needle system.

Device Features

• Voice Instructions: The device features an electronic voice instruction system that guides the user through the steps of the injection.
• Visual Cues: It includes a visual indicator to confirm when the injection is complete.
• Administration: The medication is intended for injection into the muscle or the layer of fat just under the skin of the outer thigh.

The auto-injector is available in several versions, each designed for specific patient weight categories.

FDA Approval Status

Auvi-Q (epinephrine injection) was first approved by the U.S. Food and Drug Administration (FDA) in August 2012. It is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in patients who are determined to be at risk for these reactions.

Regulatory History

In October 2015, the manufacturer issued a voluntary nationwide recall of all Auvi-Q units then on the market due to concerns that the devices might not deliver the correct amount of medication. After addressing these issues and transitioning manufacturing, the product was reintroduced to the U.S. market in early 2017.

Safety and Monitoring

The FDA has not issued a Boxed Warning for Auvi-Q, and there is no Risk Evaluation and Mitigation Strategy (REMS) required for its distribution. It is available by prescription only and is not classified as a controlled substance.

Factors Influencing Cost

The price you pay for Auvi-Q can vary significantly based on several factors:

• Insurance Coverage: Your out-of-pocket cost depends on your specific health insurance plan, including your deductible, co-pay, or co-insurance requirements.
• Pharmacy Choice: Different pharmacies may have different retail prices for the medication.
• Dosage: Auvi-Q is available in different strengths (0.1 mg, 0.15 mg, and 0.3 mg), which may affect the price.

Financial Assistance Programs

The manufacturer of Auvi-Q often provides programs to help reduce the cost for eligible patients:

• Commercial Insurance: Patients with private insurance may be eligible for savings cards that lower or eliminate co-pays.
• Uninsured or Underinsured: There are programs available for patients without insurance or those whose insurance does not cover the drug, provided they meet certain income requirements.

Generic Alternatives

While Auvi-Q is a brand-name device with unique features like voice instructions, other epinephrine auto-injectors are available. Generic versions of epinephrine injectors are typically less expensive than brand-name products, though they may function differently than the Auvi-Q device.