Pronunciation:

jap-a-NEEZ en-sef-a-LYTE-is VYE-rus vak-SEEN, in-AK-ti-vay-ted ad-SORBD

Brand Names:

• Ixiaro

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Japanese encephalitis virus vaccine, inactivated adsorbed (IXIARO(R)) is used to prevent infection caused by the Japanese encephalitis virus. It works by causing your body to produce its own protection (antibodies) against the virus.

Japanese encephalitis is caused by the bite of a mosquito that lives in certain parts of Asia. It is a serious infection that can cause flu-like symptoms (fever, chills, tiredness, headache, nausea, and vomiting), confusion, agitation, brain damage, and possibly death. This vaccine does not protect against encephalitis caused by other viruses.

This vaccine is only available from your doctor or other authorized health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Japanese encephalitis virus vaccine, inactivated adsorbed in children and teenagers below 17 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Japanese encephalitis virus vaccine, inactivated adsorbed in the elderly.

Pregnancy—

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Hypersensitivity to protamine sulfate, history of or
• Thrombocytopenia (low blood platelet count)—May cause side effects to become worse.

• High fever (more than 100°F) or
• Infection—The symptoms of the condition may be confused with the possible side effects of the vaccine.

• Immune deficiency or
• Immune system problem—May not work properly in patients with these conditions and may cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into the muscle of your upper arm.

This vaccine is given in 2 doses. Dose 2 is scheduled 28 days after Dose 1. It is very important that you receive both doses of the vaccine at least 7 days before you plan to travel out of the country. If you miss the second shot, call your doctor to make another appointment as soon as possible.

Precautions While Using This Medicine:

It is very important that you return to your doctor at the right time for the second dose. Be sure to tell your doctor about any side effects that occur after you receive this vaccine.

Since the vaccine may not protect everyone completely, it is very important that you use precautions to reduce your chance of mosquito bites. These include using insect repellents and mosquito nets, wearing protective clothing, and staying indoors during twilight and after dark.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Body aches or pain

difficulty with breathing

ear congestion

loss of voice

nasal congestion

sneezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

joint pain

muscle cramps or stiffness

swollen joints

Less common

Back pain

pain, itching, redness, or swelling where the shot was given

rash

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.