Site provided by Valneva USA, Inc.

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.

    

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.

    

 

 

Make sure they’re protected
against Japanese encephalitis (JE).

JE Treatment

There is no specific treatment for JE; prevention is the best protection.3

 The only available care for JE survivors is supportive, which can range from immediate life support measures, to long-term rehabilitation.1,3,4

JE virus is the most important cause of viral encephalitis in Asia.1

– World Health Organization (WHO)

There is no specific treatment for JE.3

– Centers for Disease Control and Prevention (CDC)

JE Risk Reduction Strategies for Travelers to Asia


Strategies for reducing JE risk for travelers include barrier protection, environmental protection, reduced exposure, 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 Vaccination14,15

Vaccination is recommended for travelers staying in Asia 1 month or more in endemic areas during the JE virus transmission season, which may be year-round in some areas.

Vaccination should be considered for travelers:

  • Who are uncertain of destination, activities, or travel duration
  • Whose activities increase their risk of exposure to JE:
    • Spending substantial time outdoors
    • Engaging in extensive outdoor activities
    • Spending time outdoors at night
    • Spending time in rural or agricultural areas
    • Staying in accommodations without air conditioning, screens, or bed nets
  • Who are traveling to an area with an ongoing JE outbreak

Vaccination is not recommended for short-term travelers (less than 4 weeks) whose visits will be restricted to urban areas or times outside a well-defined JE virus transmission season.

JE Risk Reduction Strategies for Travelers to Asia


Strategies for reducing JE risk for travelers include barrier protection, environmental protection, reduced exposure, 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 Vaccination14,15

Vaccination is recommended for travelers staying in Asia 1 month or more in endemic areas during the JE virus transmission season, which may be year-round in some areas.

Vaccination should be considered for travelers:

  • Who are uncertain of destination, activities, or travel duration
  • Whose activities increase their risk of exposure to JE:
    • Spending substantial time outdoors
    • Engaging in extensive outdoor activities
    • Spending time outdoors at night
    • Spending time in rural or agricultural areas
    • Staying in accommodations without air conditioning, screens, or bed nets
  • Who are traveling to an area with an ongoing JE outbreak

Vaccination is not recommended for short-term travelers (less than 4 weeks) whose visits will be restricted to urban areas or times outside a well-defined JE virus transmission season.

JE Checklist for Travel to Asia14,15

Assess Risk of JE Virus Exposure

Destination, duration, activities

Barrier Protection & Mosquito Avoidance14

  • Insect repellent
  • Bed nets
  • Aerosol room insecticides
  • Minimize outdoor and evening activity

The 4 Os of Je Vaccination14,15

Give IXIARO®

For travel in endemic areas:

ONE (1) MONTH

Consider IXIARO®

For travel less than 1 month:

OUTDOORS:

  • Substantial time outdoors
  • Extensive outdoor activities
  • Spending time outdoors at night
  • Time in rural or agricultural areas
  • Accommodation without air conditioning,
    screens, or bed nets

OTHER PLANS:

  • Uncertain destinations
  • Uncertain activities
  • Uncertain travel duration

OUTBREAKS:

  • Traveling during a JE outbreak

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.

Valneva USA, Inc.
910 Clopper Road, Suite 160S
Gaithersburg, MD 20878, USA

Customer Service
+1 866 223 7118

Medical Information
+1 844 349 4276
     (8443-IXIARO)

This website is intended for US-based healthcare professionals.

1807-US-IX-044-1018 | 10/18 | Copyright © 2018 Valneva USA, Inc. All Rights Reserved