HAVRIX (hepatitis a vaccine, inactivated) 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.

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, whenever solution and container permit. With thorough agitation, HAVRIX (hepatitis a vaccine, inactivated) is a homogeneous, turbid, white suspension. Discard if it appears otherwise.

Recommended Dose and Schedule

HAVRIX (hepatitis a vaccine, inactivated) should be administered by intramuscular injection. Do not administer intravenously, intradermally, or subcutaneously. In adults, the injection should be given in the deltoid region. HAVRIX (hepatitis a vaccine, inactivated) should not be administered in the gluteal region; such injections may result in suboptimal response.

Children and Adolescents: Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later in order to ensure the highest antibody titers.

Adults: Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later in order to ensure the highest antibody titers.

Dosage Forms And Strengths

HAVRIX (hepatitis a vaccine, inactivated) is a suspension available in single-dose vials and prefilled syringes for intramuscular injection.

Each 0.5-mL pediatric dose of vaccine consists of 720 EL.U. of viral antigen.

Each 1-mL adult dose of vaccine consists of 1440 EL.U. of viral antigen.

Storage And Handling

HAVRIX (hepatitis a vaccine, inactivated) is available in single-dose vials and prefilled TIP-LOK® syringes.

720 EL.U./0.5 mL in Single-Dose Vials and Prefilled Syringes (Preservative Free Formulation)

NDC 58160-825-11 Package of 10 Single-Dose Vials
NDC 58160-825-46 Package of 5 Prefilled Disposable TIP-LOK Syringes (packaged without needles)

1440 EL.U./mL in Single-Dose Vials and Prefilled Syringes (Preservative Free Formulation)

NDC 58160-826-11 Package of 10 Single-Dose Vials
NDC 58160-826-46 Package of 5 Prefilled Disposable TIP-LOK Syringes (packaged without needles)

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

Manufactured by: GlaxoSmithKline Biologicals, Rixensart, Belgium. Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709. FDA revision date: n/a

Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.