INDICATION & USAGE
IXIARO is a vaccine indicated for the prevention of disease caused by JE virus, approved for use in individuals 2 months of age and older.
Important Safety Information
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese encephalitis vaccine, 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 might be considered.
Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO. Syncope can occur in association with administration of injectable vaccines, including IXIARO. Procedures should be in place to prevent injury from falling and manage syncopal reactions.
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, myalgia, and injection site pain and tenderness in adults.
Healthcare practitioners 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. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO).
Please see full Prescribing Information.
Learn about the devastating consequences of JE through first-person accounts, as real patients and families affected by JE share their stories.
Make sure they’re protected
against Japanese encephalitis (JE).
JE virus is the most important cause of viral encephalitis in Asia.1
– World Health Organization (WHO)
Reducing Risk of JE for Travelers to Asia
Since JE virus is transmitted through mosquito bites, strategies for reducing JE risk involve minimizing mosquito exposure. These include barrier protection, environmental protection, and vaccination.14
Barrier protection
includes using insect repellent on both skin and clothing, and wearing proper clothing whenever outdoors.14
Environmental protection
includes staying in accommodations with air-conditioned or well-screened rooms, or using bed nets and aerosol room insecticides.14
Reduced exposure
includes minimizing outdoor activities during peak biting hours, typically from dusk to dawn.14
CDC Guidelines for Vaccination15
VACCINATION IS RECOMMENDED for persons moving to a JE-endemic country to live, longer-term travelers (eg, 1 month or longer), and frequent travelers to JE-endemic areas.
CONSIDER RISK AND VACCINATE BASED ON:
- Shorter-term travel itineraries (eg, less than 1 month) that increase risk of exposure to JE virus based on planned travel:
- season
- activities
- location
- accommodations
- duration
-
Travel itineraries that have uncertain specific durations of travel, destinations, or activities
VACCINATION IS NOT RECOMMENDED for travelers with very low-risk itineraries, such as shorter-term travel limited to urban areas or travel that occurs outside of a well-defined JE virus transmission season.
Reducing Risk of JE for Travelers to Asia
Since JE virus is transmitted through mosquito bites, strategies for reducing JE risk involve minimizing mosquito exposure. These include barrier protection, environmental protection, and vaccination.14
Barrier protection
includes using insect repellent on both skin and clothing, and wearing proper clothing whenever outdoors.14
Environmental protection
includes staying in accommodations with air-conditioned or well-screened rooms, or using bed nets and aerosol room insecticides.14
Reduced exposure
includes minimizing outdoor activities during peak biting hours, typically from dusk to dawn.14
CDC Guidelines for Vaccination15
VACCINATION IS RECOMMENDED for persons moving to a JE-endemic country to live, longer-term travelers (eg, 1 month or longer), and frequent travelers toJE-endemic areas.
CONSIDER RISK AND VACCINATE BASED ON:
-
Shorter-term travel itineraries (eg, less than 1 month) that increase risk of exposure to JE virus based on planned travel:
- season
- activities
- location
- accommodations
- duration
-
Travel itineraries that have uncertain specific durations of travel, destinations, or activities
VACCINATION IS NOT RECOMMENDED for travelers with very low-risk itineraries, such as shorter-term travel limited to urban areas or travel that occurs outside of a well-defined JE virus transmission season.
JE Checklist for Travel to Asia
Assess Risk of JE Virus Exposure
Destination, duration, activities
Barrier Protection & Mosquito Avoidance14
- Insect repellent
- Bed nets
- Aerosol room insecticides
- Minimal outdoor activity, including from dusk to dawn
- Proper clothing whenever outdoors
Indication & Usage
IXIARO is a vaccine indicated for the prevention of disease caused by JE virus, approved for use in individuals 2 months of age and older.
Important Safety Information
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese encephalitis vaccine, 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 might be considered.
Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO. Syncope can occur in association with administration of injectable vaccines, including IXIARO. Procedures should be in place to prevent injury from falling and manage syncopal reactions.
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, myalgia, and injection site pain and tenderness in adults.
Healthcare practitioners 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. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO), or +1-301-556-4500.
Please see full Prescribing Information.
Valneva USA, Inc.
4550 Montgomery Ave.,
Suite 460
Bethesda, MD 20814
USA
Customer Service
+1-833-403-8778
Medical Information
+1 844 349 4276
(8443-IXIARO)
or +1-301-556-4500
This website is intended for US-based healthcare professionals.
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