Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 12 January 2018

Indication(s)

IXIARO is a vaccine indicated for active immunization for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older. (1)

Full Prescribing information

Alternative doses

Age Dose* Primary Series
Children 2 months
to <3 years of age
0.25mL 2 doses,
28 days apart
Individuals 3 years
of age and older
0.50mL 2 doses,
28 days apart

*To administer a 0.25 mL dose, expel and discard half of the volume from the 0.5 mL pre-filled syringe by pushing the plunger stopper up to the edge of the red line on the syringe barrel prior to injection. (2.3)

Complete the primary immunization series at least 1 week prior to potential exposure to JEV. (2.1, 14)

Individuals 17 years of age and older who have received a primary immunization series more than 1 year previously may be given a booster dose if ongoing exposure or re-exposure to JEV is expected. (2.1)

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Advisory information

contraindications

Severe allergic reaction, (e.g., anaphylaxis,) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. (4)

Special warnings and precautions

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. (5.1)

Adverse reactions
In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). (6.1)

In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). (6.1)

In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). (6.1)

In adolescents 12 to <18 years of age, the most common injection site reactions were pain (15%) and tenderness (10%). (6.1)

In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%). (6.1)

More information

Category Value
Authorisation number BLA125280
Orphan designation No
Product NDC 42515-001
Date First Approved 30-03-2009
Marketing authorisation holder Valneva Scotland Ltd.