Indications and Usage
HAVRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus (HAV) for persons ≥12 months of age. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.
Dosage and Administration
- HAVRIX is administered by intramuscular injection.
- Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster dose administered between 6 to 12 months later.
- Adults: A single 1-mL dose and a 1-mL booster dose administered between 6 to 12 months later.Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, 6-month schedule.
Dosage Forms and Strengths
HAVRIX is a sterile suspension available in the following presentations:
- 0.5 mL single-dose vials and prefilled syringes.
- 1.0 mL single-dose vials and prefilled syringes.
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin.
Warnings and Precaution
- HAVRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals.
- Immunocompromised persons may have a diminished immune response to HAVRIX.
- HAVRIX may not prevent hepatitis A infection in individuals with unrecognized hepatitis A infection at the time of vaccination.
The most common solicited adverse events were injection-site soreness (56% of adults and 21% of children) and headache (14% of adults and less than 9% of children).
Use in Specific Populations
- Safety and effectiveness of HAVRIX have not been established in pregnant women and nursing mothers. HAVRIX should only be given to a pregnant woman if clearly needed,