IXIARO®

What is IXIARO used for?

• IXIARO is a vaccine for use in individuals 2 months of age and older to help protect against Japanese encephalitis (JE). You cannot get the disease from IXIARO.
• You will need 2 doses of the vaccine.
• You should consult your health care provider on the need for a booster dose of IXIARO.
• You should still protect yourself from mosquito bites even if you have had the IXIARO vaccine.
• IXIARO may not fully protect everyone who gets the vaccine.
• IXIARO does not protect against encephalitis caused by other viruses/pathogens.
• IXIARO does not protect against other diseases transmitted by mosquitoes.

You should not get IXIARO if you:

• are allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
• had an allergic reaction after getting a dose of the vaccine or any other JEV vaccine.

IXIARO is not approved for use in infants below the age of 2 months.

What Warnings should I know about IXIARO?

• IXIARO can cause allergic reactions. Tell your health care provider immediately if you experience difficulty breathing, hoarseness or wheezing, hives, or dizziness, weakness, or fast heartbeat.
• Fainting can occur with administration of IXIARO.
• Vaccination with IXIARO may not protect all who receive the vaccine.

What should I tell my health care provider?
It is very important to tell your health care provider if you:

• have had an allergic reaction to a previous dose of IXIARO or any other JEV vaccine.
• have a bleeding disorder or a reduction in blood platelets, which increases risk of bleeding
• or bruising (thrombocytopenia) and cannot receive injections in the arm.
• have a weakened immune system, for example, due to a genetic defect or HIV infection.
• are or may be pregnant, or are breast feeding. IXIARO has not been studied in pregnant women or nursing mothers.
• currently have any illness with a fever of more than 100 F (37.8 C).
• take any medicines, even those you can buy over the counter.

What are the side effects of IXIARO?
The most common side effects in adolescents >12 years of age and adults are headache, muscle pain and injection site reactions (e.g. pain, swelling, tenderness, redness). Nausea, skin rash, fatigue, flu-like illness, fever, irritability and loss of appetite may also occur.
The most common side effects in children below the age of 12 years are fever, irritability, diarrhea, vomiting, loss of appetite, injection site pain and injection site redness.
Contact your health care provider right away if you get any symptoms after receiving IXIARO that concern you.
Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction:

• difficulty breathing
• hoarseness or wheezing
• hives
• dizziness, weakness or fast heart beat

Do not administer intravenously, intradermally,or subcutaneously. IXIARO is administered intramuscularly.

Visit IXIARO.com, a website for travelers focusing on the risk and prevention of Japanese encephalitis for travelers to Asia and other regions or areas where Japanese encephalitis may be present.

View Prescribing Information for IXIARO® here

To report suspected adverse reactions
Contact Valneva at +1-844-349-4276 or VAERS at +1-800-822-7967 or https://vaers.hhs.gov.