Indications and Usage
AVAXIM is indicated for active immunization against infection caused by hepatitis A virus (HAV) in persons 12 years of age and older. AVAXIM can be used for primary immunization or as a booster following primary immunization with AVAXIM or other similar hepatitis A vaccines.
Dosage and Administration
- Primary immunization is achieved with one single dose of vaccine. In order to provide long term protection, a booster should be given six to twelve months later. Based on current data, a further booster dose may be required after 10 years.
- The recommended dose is 0.5 mL administered intramuscularly.
- AVAXIM is indicated for persons 12 years of age and older.
Dosage Forms and Strengths
AVAXIM is supplied in packages containing either: one pre-filled single dose syringe with a choice of two needles (1 x 25G x 16 mm and 1 x 25G x 25 mm), or one pre-filled single dose syringe with attached needle.
- Immunization with AVAXIM should be deferred in the presence of any acute illness, including febrile illness to avoid superimposing adverse effects from the vaccine on the underlying illness or mistakenly identifying a manifestation of the underlying illness as a complication of vaccine use. A minor afebrile illness such as mild upper respiratory infection is not usually reason to defer immunization.
- Allergy to any component of AVAXIM or an anaphylactic or other allergic reaction to a previous dose of AVAXIM are contraindications to vaccination.
- The vaccine should not be administered intravenously or intradermally.
Warnings and Precaution
- AVAXIM does not provide protection against infection caused by hepatitis B virus, hepatitis C virus, delta virus, hepatitis E virus, or by other liver pathogens, other than hepatitis A virus.
- Seropositivity against hepatitis A virus is not a contraindication. AVAXIM is as well tolerated in seropositive as in seronegative subjects.
- Because of the incubation period of hepatitis A, infection may be present at the time of vaccination; if so, the vaccine may be ineffective.
- Intramuscular injections should be given with care in persons suffering from coagulation disorders or on anticoagulant therapy because of the risk of hemorrhage.
- AVAXIM should not be administered into the buttocks due to the varying amount of fatty tissue in this region, nor by the intradermal route, since these methods of administration may induce a weaker immune response.
- Immunocompromised persons (whether from disease or treatment) may not obtain the expected immune response. If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment. If AVAXIM is used in these persons, seroconversion should be confirmed by antibody testing.
- As with any vaccine, immunization with AVAXIM may not protect 100% of susceptible individuals.
In six clinical trials conducted which involved over 2,200 participants, adverse events were usually mild and confined to the first few days after vaccination with spontaneous recovery. The most common local reaction was mild pain (11.7%) at the injection site, occasionally associated with redness (0.5% over 3 cm). Mild fever (5.2%), weakness (13.5%), headache (9.7%), muscle or joint ache (10.3%) or gastro-intestinal tract disorders (6.1%) such as nausea, vomiting, diarrhea, or pain, were also reported. Mild transient elevation of serum transaminases has been reported on rare occasions.
Use in Specific Populations
- Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring hepatitis A. As the vaccine is inactivated, any risk to the embryo or the fetus is improbable. The benefits versus the risks of administering AVAXIM in pregnancy should carefully be evaluated.
- The effect of administration of AVAXIM during lactation has not been assessed. As AVAXIM is inactivated, any risk to the mother or the infant is improbable. The benefits versus the risks of administering AVAXIM during lactation should carefully be evaluated.