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Havrix (Hepatitis A Vaccine (Inactivated)) - Indications and Dosage



HAVRIX is indicated for active immunization of persons >/=2 years of age against disease caused by hepatitis A virus (HAV).

HAVRIX will not prevent hepatitis caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus, or other pathogens known to infect the liver.

Immunization with HAVRIX is indicated for those people desiring protection against hepatitis A. Primary immunization should be completed at least 2 weeks prior to expected exposure to HAV. Individuals who are, or will be, at increased risk of infection by HAV include:

  • Travelers: Persons traveling to areas of higher endemicity for hepatitis A. These areas include, but are not limited to, Africa, Asia (except Japan), the Mediterranean basin, eastern Europe, the Middle East, Central and South America, Mexico, and parts of the Caribbean. Current CDC advisories should be consulted with regard to specific locales.
  • Military Personnel
  • People Living in, or Relocating to, Areas of High Endemicity
  • Certain Ethnic and Geographic Populations That Experience Cyclic Hepatitis A Epidemics, such as: Native peoples of Alaska and the Americas.
  • People With Chronic Liver Disease, including:
    • Alcoholic cirrhosis
    • Chronic hepatitis B
    • Chronic hepatitis C
    • Autoimmune hepatitis
    • Primary biliary cirrhosis
  • Others:
    • Persons engaging in high-risk sexual activity (such as men having sex with men) 18
    • Residents of a community experiencing an outbreak of hepatitis A
    • Users of illicit injectable drugs
    • Persons who have clotting factor disorders (hemophiliacs and other recipients of therapeutic blood products).
      Hepatitis A transmission has been documented in persons with clotting disorders. Susceptible persons in this category, especially those who receive solvent detergent-treated clotting factor concentrates, should be vaccinated against hepatitis A19(see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
    • Although the epidemiology of hepatitis A does not permit the identification of other specific populations at high risk of disease, outbreaks of hepatitis A or exposure to hepatitis A virus have been described in a variety of populations in which HAVRIX may be useful:

·Certain institutional workers (e.g., caretakers for the developmentally challenged)

·Employees of child day-care centers

·Laboratory workers who handle live hepatitis A virus

·Handlers of primate animals that may be harboring HAV

· People Exposed to Hepatitis A:

For those requiring both immediate and long-term protection, HAVRIX may be administered concomitantly with IG.

The Advisory Committee on Immunization Practices (ACIP) has issued the following recommendations regarding food handlers: "Persons who work as food handlers can contract hepatitis A and potentially transmit HAV to others. To decrease the frequency of evaluations of food handlers with hepatitis A and the need for post-exposure prophylaxis of patrons, consideration may be given to vaccination of employees who work in areas where state and local health authorities or private employers determine that such vaccination is cost-effective." 19


HAVRIX should be administered by intramuscular injection. Do not inject intravenously, intradermally, or subcutaneously. In adults, the injection should be given in the deltoid region. HAVRIX should not be administered in the gluteal region; such injections may result in suboptimal response.

HAVRIX may be administered concomitantly with IG, although the ultimate antibody titer obtained is likely to be lower than when the vaccine is given alone. HAVRIX has been administered simultaneously with ENGERIX-B without interference with their respective immune responses.

For individuals with clotting factor disorders at risk of hematoma formation following intramuscular injection, the ACIP recommends that when any intramuscular vaccine is indicated for such patients, ".. . the vaccine should be administered intramuscularly if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered with reasonable safety by this route. If the patient receives antihemophilia or other similar therapy, intramuscular vaccinations can be scheduled shortly after such therapy is administered. A fine needle (/=2 minutes. The patient or family should be instructed concerning the risk for hematoma from the injection."22

When concomitant administration of other vaccines or IG is required, they should be given with different syringes and at different injection sites.

Preparation for Administration: Shake vial or syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. With thorough agitation, HAVRIX is a slightly turbid white suspension. Discard if it appears otherwise.

The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. After removal of the appropriate volume from a single-dose vial, any vaccine remaining in the vial should be discarded.

Primary immunization for adults consists of a single dose of 1440 EL.U. in 1 mL. Primary immunization for children and adolescents (2 through 18 years of age) may follow either of these 2 schedules:

Group Dose Schedule
Children and adolescents (2 through 18 years of age) Primary course: 360 EL.U./0.5 mL two doses, given 1 month apart (month 0 and month 1)
360 EL.U./0.5 mL
6 to 12 months after primary course
Primary course: 720 EL.U./0.5 mL one dose
(month 0)
720 EL.U./0.5 mL
6 to 12 months after primary course

Individuals should not be alternated between the 360 EL.U. and 720 EL.U. doses. Those who receive an initial 360 EL.U. dose should continue on the 360 EL.U. dosing schedule. Likewise, those individuals who receive a single 720 EL.U. primary dose should receive a 720 EL.U. booster dose.

For all age groups, a booster dose is recommended anytime between 6 and 12 months after the initiation of the primary dose in order to ensure the highest antibody titers.

In those with an impaired immune system, adequate anti-HAV response may not be obtained after the primary immunization course. Such patients may therefore require administration of additional doses of vaccine.


Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen. Do not dilute to administer.


HAVRIX is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK® syringes.

360 EL.U./0.5 mL in Single-Dose Vials

NDC 58160-836-01 Package of 1

720 EL.U./0.5 mL in Single-Dose Vials and Prefilled Syringes

NDC 58160-837-01 Package of 1 Single-Dose Vial

NDC 58160-837-11 Package of 10 Single-Dose Vials

NDC 58160-837-46 Package of 5 Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-837-50 Package of 25 Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-837-56 Package of 25 Prefilled Disposable TIP-LOK Syringes with 1-inch 25-gauge BD SAFETYGLIDE™ Needles

NDC 58160-837-58 Package of 25 Prefilled Disposable TIP-LOK Syringes with 1-inch 23-gauge BD SAFETYGLIDE™ Needles

1440 EL.U./mL in Single-Dose Vials and Prefilled Syringes

NDC 58160-835-01 Package of 1 Single-Dose Vial

NDC 58160-835-41 Package of 1 Prefilled Disposable TIP-LOK Syringe (packaged without needle)

NDC 58160-835-46 Package of 5 Prefilled Disposable TIP-LOK Syringes (packaged without needles)

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