Dosing and uses of Ixiaro (Japanese encephalitis virus vaccine)
Adult dosage forms and strengths
suspension for IM injection
- ~6mcg/0.5mL prefilled syringe
Active Immunization
Vaccine recommended for adults and children aged ≥2 months at increased risk of Japanese encephalitis virus (JEV) during travel to Asia
Primary immunization series: 2 doses (0.5 mL) IM administered 28 days apart
Booster dose (individuals ≥17 years): If the primary series was administered >1 year; may be given prior to potential re-exposure
Complete all immunization at least 1 week prior to potential exposure to JEV
Pediatric dosage forms and strengths
suspension for IM injection
- ~6mcg/0.5mL prefilled syringe
Active Immunization
Vaccine recommended for adults and children aged ≥2 months at increased risk of Japanese encephalitis virus (JEV) during travel to Asia
<2 months: Safety and efficacy not established
Primary immunization series (2 months to <3 years): 2 doses (0.25 mL) IM administered 28 days apart
Primary immunization series (≥3 years): 2 doses (0.5 mL) IM administered 28 days apart
Booster dose (2 months to <17 years): Safety and immunogenicity of booster dose has not been evaluated
Complete all immunization at least 1 week prior to potential exposure to JEV
Ixiaro (Japanese encephalitis virus vaccine) adverse (side) effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
>10%
Injection site reaction (55.4%)
Headache (27.9%)
Myalgia (15.6%)
Influenza-like illness (12.3%)
Fatigue (11.3%)
1-10%
Erythema at injection site (9.6%)
Nausea (6.6%)
Warnings
Contraindications
Severe allergic reaction
Cautions
Contains protamine sulfate, potentially allergenic
Pregnancy and lactation
Pregnancy category: B
Lactation: Not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ixiaro (Japanese encephalitis virus vaccine)
Mechanism of action
JE virus antigen, inactivated adsorbed
These products convey active immunity via stimulation of production of endogenously produced antibodies
The onset of protection from disease is relatively slow, but duration is long lasting (years)
Administration
IM Preparation
During storage, a clear liquid with a white precipitate can be observed; shake syringe or vial well to obtain a white, opaque, homogeneous suspension
Inspected visually for particulate matter and discoloration prior to administration
0.25 mL dose preparation: After shaking syringe to obtain homogenous suspension, push the plunger stopper to the edge of the red line on the syringe barrel and discard expelled volume into medical waste container
IM Administration
For IM administration only; do not administer IV, SC, or Id
Administration sites
- Aged 2-11 months: Anterolateral aspect of the thigh
- Aged 1 to <3 years: Anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate)
- ≥3 years: Deltoid muscle
Storage
Store refrigerated between 2-8°C (35-46°F)
