HAVRIX is indicated for active immunization of persons ≥12 months of age against disease caused by hepatitis A virus (HAV). Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. The Advisory Committee on Immunization Practices (ACIP) has issued recommendations for hepatitis A vaccination for persons who are at increased risk for infection and for any person wishing to obtain immunity (www.cdc.gov).⁶

When passive protection against hepatitis A is required either following exposure to hepatitis A virus or in persons requiring both immediate and long-term protection, HAVRIX may be administered concomitantly with IG with different syringes and at different injection sites.

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.

Children and Adolescents: Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single dose of 720 EL.U. in 0.5 mL and a booster dose (720 EL.U. in 0.5 mL) should be administered anytime between 6 and 12 months later.

Adults: Primary immunization for adults consists of a single dose of 1440 EL.U. in 1 mL and a booster dose (1440 EL.U. in 1 mL) should be administered anytime between 6 and 12 months later.

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

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.

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 (<23 gauge) should be used for the vaccination and firm pressure applied to the site, without rubbing, for >2 minutes. The patient or family should be instructed concerning the risk for hematoma from the injection.⁸

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

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.

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.

STORAGE

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.

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)

1440 EL.U./mL in Single-Dose Vials and Prefilled Syringes NDC 58160-835-01 Package of 1 Single-Dose Vial

NDC 58160-835-11 Package of 10 Single-Dose Vials

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)

REFERENCES

6.    Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48(RR-12):26-29.

8.    Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices and the American Academy of Family Physicians. MMWR 2002;51(RR-2):23-24.

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