hepatitis a vaccine inactivated (Rx)

Brand and Other Names:Havrix, Vaqta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection

  • 50 units/mL (Vaqta adult dose)
  • 1440 ELISA units/mL (Havrix adult dose)

Hepatitis A Immunization

Indicated as active immunization against hepatitis A virus (HAV) for any person seeking protection, and persons with the following risks: homelessness, men who have sex with men, IV or non-IV illicit drug abusers, chronic liver disease, clotting factor disorders, international travel to endemic areas, close contact with an international adoptee, persons working with HAV-infected primates or HAV in lab setting

2-dose vaccination series

  • ≥19 years: 1 mL IM (primary dose)
  • Administer primary dose at least 2 weeks before expected exposure to HAV
  • Havrix: Administer booster dose 6-12 mo after primary dose
  • Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose

Preexposure protection against HAV for travelers (ACIP guidelines)

  • 1 mL IM given at least 2 weeks before expected exposure to HAV
  • For persons not previously vaccinated with hepatitis A vaccine, administer dose as soon as travel is considered, and complete 2-dose series according to routine schedule
  • Also consider giving immune globulin for patients who are immunocompromised or have chronic liver disease, or those 40 yr or older who are otherwise healthy

Postexposure prophylaxis (PEP) for HAV

  • 1 mL IM
  • A second dose is not required for PEP; however, for long-term immunity, ACIP recommends completing the 2-dose series
  • Age ≥40 years: Consider the need to also give immunoglobulin
  • Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites

Additional Information

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/default.htm

Dosage Forms & Strengths

injection

  • 25 units/0.5 mL (Vaqta pediatric dose)
  • 720 ELISA units/0.5mL (Havrix pediatric dose)

Hepatitis A Immunization

Indicated as routine vaccination for children at least 12 months of age (ACIP guidelines)

<12 months: Not indicated; if administered, not counted toward the routine 2-dose series

≥12 months through 18 years (2-dose series)

  • Primary dose: 0.5 mL IM
  • Havrix: Administer booster dose 6-12 mo after primary dose
  • Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose
  • Children who have received 1 dose before age 24 months, should receive a second dose 6-18 months after the first dose

Catch up schedule

  • For any person ≥2 yr who has not already received hepatitis A vaccine series, give 2 doses separated by 6-18 months if immunity against hepatitis A virus infection is desired
  • Minimum interval between the 2-dose series is 6 months

Preexposure protection against HAV for travelers (ACIP guidelines)

  • <6 months: Do not administer hepatitis A vaccine, but do administer immune globulin
  • 6-11 months: 0.5 mL IM; this dose does not count toward routine 2-dose vaccination series
  • 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete 2-dose series according to routine schedule
  • Immunocompromised or chronic liver disease: 0.5 mL IM; also consider giving immune globulin

Postexposure prophylaxis (PEP) for HAV

  • 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete 2-dose series according to routine schedule
  • Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites
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Interactions

Interaction Checker

and hepatitis a vaccine inactivated

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            Adverse Effects

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            >10%

            Injection site tenderness (3-56%), erythema (1-22%), warmth (1-17%), swelling (9-11%)

            Irritability (11-36%)

            Anorexia (1-19%)

            Drowsiness (15-17%)

            Headache (1-16%)

            Fever > 100.4 F (9-11%)

            1-10%

            URI (1-10%)

            Otitis media (8%)

            Rhinorrhea (6%)

            Diarrhea (1-6%)

            Cough (1-5%)

            Rash (1-5%)

            Weakness/fatigue (4%)

            Vomiting (1-4%)

            Fever > 102 F (3%)

            Crying (2%)

            <1%

            Hematoma

            Incr. CPK

            Photophobia

            Vertigo

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            Warnings

            Contraindications

            Documented hypersensitivity

            Cautions

            First dose at least 2 wk before exposure to HAV

            Current exposure to HAV: may co-administer IG

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not established

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Attenuated strain of hepatitis A virus (HAV) which stimulates active immunity

            Pharmacokinetics

            Onset: 4 wk

            Duration: unknown

            These products convey active immunity via stimulation of production of endogenously produced antibodies

            The onset of protection from disease is relatively slow, but duration is long lasting (years)

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            Administration

            IM Preparation

            Do not dilute

            Shake vial or syringe well to obtain a slightly opaque, white suspension before administering

            Discard if suspension does not appear homogenous or if extraneous particulate matter remains or discoloration observed

            IM Administration

            Adults, adolescents, and children aged ≥2 years: Administer in deltoid region

            Children aged 12-23 months: Administer in anterolateral area of the thigh

            Storage

            Refrigerate at 2-8°C (36-46°F)

            Do not freeze; discard if vaccine has been frozen (freezing destroys potency)

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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