DOSAGE AND ADMINISTRATION
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)
|
|
|
Booster:
360 EL.U./0.5 mL
|
6 to 12 months after primary course
|
|
|
OR |
|
|
Primary course: 720 EL.U./0.5 mL
|
one dose
(month 0)
|
|
|
Booster:
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.
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.
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