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IXIARO HCP

The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research suspended the license for IXCHIQ® on August 22, 2025. IXCHIQ® may not be distributed or administered in the United States until further notice.


Important Safety Information
Prescribing Information
References
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How to order IXIARO

Photo of a IXIARO Japanese Encephalitis vaccine product box.

US Private Customers:

PDF iconIXIARO® Authorized Distributors of Record

US Federal Government Customers:

Toll Free number
+1-833-403-8778
Fax
614-495-5555
Email
GMB-SPS-VALNEVA@cordlogistics.com
Hours of Operation
Monday to Friday
8:30 a.m. – 5:00 p.m. EST
Medical Inquiries,
Adverse events and
Product complaints
Toll-free number+1-844-349-4276medinfo@valneva.com
Photo of a IXIARO Japanese Encephalitis vaccine product box.

INDICATION

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

IMPORTANT SAFETY 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. Because of uncertainty as to which component of the vaccine may be responsible, 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.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

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%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). 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%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

INDICATION

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

IMPORTANT SAFETY 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. Because of uncertainty as to which component of the vaccine may be responsible, 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.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

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%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). 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%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

INDICATION

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

IMPORTANT SAFETY 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. Because of uncertainty as to which component of the vaccine may be responsible, 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.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

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%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). 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%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

INDICATION

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

IMPORTANT SAFETY 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. Because of uncertainty as to which component of the vaccine may be responsible, 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.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

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%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). 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%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.