Vaqta 1ml Im Pfs (adults 19+)

Manufacturer MERCK SHARP & DOHME Active Ingredient Hepatitis A Vaccine(hep a TYE tis aye vak SEEN) Pronunciation VAK-tuh
It is used to prevent hepatitis A infection.
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Drug Class
Vaccine
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Pharmacologic Class
Inactivated viral vaccine
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Pregnancy Category
Not available
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FDA Approved
Feb 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vaqta is a vaccine that helps protect you from Hepatitis A, a serious liver infection caused by a virus. It works by teaching your body's immune system to recognize and fight off the Hepatitis A virus, so you don't get sick if you're exposed to it in the future. It's given as a shot in your muscle, usually in two doses.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the guidelines provided to ensure safe and effective use. This medication is administered via intramuscular injection.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Continue practicing good hand hygiene, especially after using the restroom and before eating, as the vaccine does not provide immediate protection and Hepatitis A is spread through contaminated food or water.
  • Complete the full two-dose series for long-term protection.
  • Inform your healthcare provider about any allergies or medical conditions, especially if you have a weakened immune system.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 mL (50 U) intramuscularly as a two-dose series. The second dose is administered 6 to 18 months after the first dose.

Condition-Specific Dosing:

post-exposure prophylaxis: Not typically used for post-exposure prophylaxis in adults; Immune globulin is preferred for immediate protection, though vaccine may be given concurrently.
travelers: Administer at least 2 weeks prior to departure for optimal protection, though some protection may be conferred earlier.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (Vaqta 25U/0.5mL is for 12 months to 18 years)
Child: Not established (Vaqta 25U/0.5mL is for 12 months to 18 years)
Adolescent: Not established (Vaqta 25U/0.5mL is for 12 months to 18 years)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific adjustment needed; however, immune response may be suboptimal in immunocompromised individuals, including those on dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Vaqta is an inactivated vaccine that induces active immunity against the Hepatitis A virus (HAV). It contains purified, inactivated HAV particles that, upon administration, stimulate the recipient's immune system to produce anti-HAV antibodies. These antibodies provide protection against future HAV infection.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (vaccine)
Tmax: Not applicable (vaccine)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (vaccine)
ProteinBinding: Not applicable (vaccine)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (vaccine)
Clearance: Not applicable (vaccine)
ExcretionRoute: Not applicable (vaccine)
Unchanged: Not applicable (vaccine)
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Pharmacodynamics

OnsetOfAction: Seroconversion (protective antibody levels) typically occurs within 2-4 weeks after the first dose in most healthy individuals.
PeakEffect: Peak antibody titers are generally observed 1 month after the second dose.
DurationOfAction: Long-term protection is expected for at least 20 years, and likely lifelong, after completion of the two-dose series.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

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
A burning, numbness, or tingling sensation that is not normal
Difficulty controlling body movements
Changes in eyesight
High fever
Severe dizziness or fainting, which can occur after or before receiving a vaccine; if you feel dizzy, inform your doctor right away

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Common side effects for all patients taking this medication:
+ Headache
+ Feeling tired or weak
+ Upset stomach
+ Decreased appetite
+ Mild fever
+ Diarrhea
+ Pain, redness, swelling, or warmth at the injection site
Additional side effects in young children:
+ Irritability
+ Drowsiness

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/CDC Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
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Seek Immediate Medical Attention If You Experience:

  • Signs of a severe allergic reaction (anaphylaxis) such as hives, swelling of the face or throat, difficulty breathing, wheezing, dizziness, or a fast heartbeat. Seek immediate medical attention if these occur.
  • Unusual weakness or numbness
  • High fever (above 102°F or 39°C)
  • Persistent or worsening injection site reactions (redness, swelling, pain)
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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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. If you have a latex allergy, consult your doctor, as some products may contain latex.

As with all vaccines, this vaccine may not provide complete protection for everyone who receives it. If you have any questions or concerns, discuss them with your doctor. Note that this vaccine will not protect you against other types of hepatitis.

This vaccine contains a non-active virus, which means it cannot cause the disease itself. However, if you have a weakened immune system or are taking medications that suppress the immune system, consult your doctor, as the vaccine may not be as effective.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of the vaccine to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Overdose is unlikely with a vaccine. Any symptoms would likely be an exaggeration of typical adverse reactions.

What to Do:

Call 1-800-222-1222 (Poison Control) or seek medical attention if concerns arise.

Drug Interactions

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Major Interactions

  • Immunosuppressants (e.g., corticosteroids, chemotherapy, radiation therapy, other immunosuppressive agents): May diminish the therapeutic effect of the vaccine due to impaired immune response. Defer vaccination if possible, or re-vaccinate after immune function recovers.
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Moderate Interactions

  • Other vaccines: Can be administered concomitantly with other inactivated vaccines or live vaccines (e.g., MMR, varicella) at different injection sites using separate syringes.

Monitoring

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Baseline Monitoring

Allergy history

Rationale: To identify contraindications to vaccine components (e.g., neomycin, aluminum hydroxide) or previous severe allergic reactions to vaccines.

Timing: Prior to administration of the first dose.

Immunization status

Rationale: To confirm need for vaccination and appropriate dosing schedule.

Timing: Prior to administration of any dose.

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Routine Monitoring

Observation for immediate adverse reactions

Frequency: Immediately post-vaccination

Target: Absence of anaphylaxis or severe allergic reaction

Action Threshold: Any signs of anaphylaxis (e.g., rash, swelling, difficulty breathing, hypotension) require immediate medical intervention.

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Symptom Monitoring

  • Injection site reactions (pain, tenderness, redness, swelling, warmth)
  • Headache
  • Fatigue
  • Low-grade fever
  • Nausea
  • Loss of appetite
  • Malaise
  • Muscle aches

Special Patient Groups

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Pregnancy

The decision to vaccinate pregnant women should be based on the potential risk of exposure to Hepatitis A and the potential benefits of vaccination. While animal reproduction studies have not been conducted, and human data are limited, the vaccine is inactivated and generally considered low risk. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Limited data, but inactivated vaccines are generally considered safe if indicated.
Second Trimester: Limited data, but inactivated vaccines are generally considered safe if indicated.
Third Trimester: Limited data, but inactivated vaccines are generally considered safe if indicated.
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Lactation

It is not known whether Vaqta is excreted in human milk. However, inactivated vaccines are generally not considered to pose a risk to breastfeeding infants. The benefits of breastfeeding should be weighed against the potential risks.

Infant Risk: Low risk
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Pediatric Use

This specific formulation (1mL, 50U) is indicated for individuals 19 years of age and older. A lower dose formulation (0.5mL, 25U) is available for children and adolescents 12 months through 18 years of age.

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Geriatric Use

No specific dose adjustment is required for geriatric patients. Immune response may be slightly diminished in older adults compared to younger adults, but the vaccine is still effective.

Clinical Information

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Clinical Pearls

  • Vaqta is an inactivated vaccine and cannot cause Hepatitis A disease.
  • Ensure the full two-dose series is completed for long-term protection.
  • Administer intramuscularly, preferably in the deltoid muscle.
  • Can be co-administered with other vaccines, but at different injection sites.
  • Patients should be observed for 15 minutes post-vaccination for immediate reactions.
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Alternative Therapies

  • Havrix (Hepatitis A Vaccine, Inactivated)
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Cost & Coverage

Average Cost: $100 - $150 per 1mL single-dose vial/syringe
Insurance Coverage: Tier 1 or Preventive (often covered at 100% under ACA)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.