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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.

    

 

 

References

 

  1. World Health Organization. Fact sheets. Japanese encephalitis. Published December 2015. http://www.who.int/mediacentre/factsheets/fs386/en. Accessed March 27, 2018.
  2. Centers for Disease Control and Prevention. Viral hemorrhagic fevers (VHFs). Updated April 2014. https://www.cdc.gov/vhf/virus-families/flaviviridae.html. Accessed March 27, 2018.
  3. Centers for Disease Control and Prevention. Japanese encephalitis. Updated August 2015 https://www.cdc.gov/japaneseencephalitis/. Accessed March 27, 2018.
  4. Centers for Disease Control and Prevention. Yellow Book 2018, Chapter 3. Updated May 2017. https://wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/japanese-encephalitis. Accessed March 27, 2018.
  5. Cheng V, Sridhar S, Wong S, et al. Japanese encephalitis virus transmitted via blood transfusion, Hong Kong, China. Emerg Infect Dis. 2018;24(1):49-57.
  6. Connor BA, Bunn WB. The changing risk of Japanese encephalitis for business travelers. Workplace Health Saf. 2015;63(12):568.
  7. Solomon T, Vaughn DW. Pathogenesis and clinical features of Japanese encephalitis and West Nile Virus infections. Curr Top Microbiol Immunol. 2002;267:171-194.
  8. Singh RK, Tiwari R, Dhole TN. Japanese encephalitis: a review of the Indian perspective. Braz J Infect Dis. 2012;16(6):564-573.
  9. Nain M, Abdin MZ, Kalia M, Vrati S. Japanese encephalitis virus invasion of cell: allies and alleys. Rev Med Virol. 2016;26(2):129-141.
  10. Buhl MR, Lindquist L. Japanese encephalitis in traveling: review of cases and seasonal risk. J Travel Med. 2009;16(3): 217-219.
  11. Tian H, Bi P, Cazelles B, et al. How environmental conditions impact mosquito ecology and Japanese encephalitis: an eco-epidemiological approach. Environ Int. 2015:79:17-24.
  12. Hills SL, Griggs AC, Fischer M. Japanese encephalitis in travelers from non-endemic countries, 1973- 2008. Am J Trop Med Hyg. 2010;82(5):930-936.
  13. Heffelfinger JD, Li X, Batmunkh N. et al. Japanese encephalitis surveillance and immunization – Asia and Western Pacific regions, 2016. Morb Mortal Wkly Rep. 2017;66(22):579-583.
  14. Centers for Disease Control and Prevention. Japanese encephalitis. Prevention. Updated August 2015 https://www.cdc.gov/japaneseencephalitis/prevention/. Accessed March 27, 2018.
  15. Centers for Disease Control and Prevention. Japanese encephalitis. Vaccine. Updated August 2015 https://www.cdc.gov/japaneseencephalitis/vaccine/index.html. Accessed March 27, 2018.
  16. IXIARO [prescribing information]. Vienna, Austria; Valneva Austria GmbH; 2018.

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.

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