Indication & Usage

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, other Japanese encephalitis vaccine, any or any component of IXIARO, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO. Individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals. Individuals with a weakened immune system may have a diminished immune response to IXIARO. Fainting may occur when receiving any injection, including IXIARO. Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967. You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.