Pronunciation:

jap-a-NEEZ en-sef-a-LYTE-is VYE-rus VAX-een, in-AK-ti-vay-ted

Brand Names:

• Je-Vax

Dosage Forms:

• Powder for Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Japanese encephalitis virus vaccine, inactivated (JE-VAX(R)) is an immunizing agent used to help prevent infection by the Japanese encephalitis virus. Japanese encephalitis is caused by the bite of a mosquito that lives in certain parts of Asia. The vaccine works by causing your body to produce its own protection (antibodies) against the virus.

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

The Japanese encephalitis virus vaccine, inactivated (JE-VAX(R)) is no longer marketed in the United States.

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—

Studies on this vaccine have been done only in adults and children 1 year of age and older. There is no specific information comparing use of this vaccine in infants under 1 year of age with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of Japanese encephalitis virus vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. In addition, immunization may be especially useful for the elderly, since older persons may have a higher risk of illness following infection with the Japanese encephalitis virus.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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:

• Hives (history of)—May increase the chance of side effects of the vaccine

Proper Use of This Medicine:

It is important that you receive 3 doses of the vaccine. If there is not enough time for you to get all 3 doses, you may get 2 doses of the vaccine. However, 2 doses of the vaccine will not protect you as well as 3 doses.

It is important that you receive all 3 doses of the vaccine at least 10 days before you plan on traveling out of the country. There is a chance of side effects that do not show up right away, and, if they do occur, they may need medical attention. In addition, the 10 days will give your body time to produce antibodies against the Japanese encephalitis virus.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The number of doses you receive and the time allowed between doses of Japanese encephalitis virus vaccine, inactivated (JE-VAX(R)) will be different for different patients.

• For help preventing Japanese encephalitis:
  • For injection dosage form:
    • Adults and children 1 year of age and older—One dose injected under the skin on days zero, seven, and thirty, for a total of three doses.
    • Children up to 1 year of age—Use and dose must be determined by your doctor.

Precautions While Using This Medicine:

Since the vaccine may not protect everyone completely, it is very important that you still use precautions to reduce your chance of mosquito bites. These include using insect repellents and mosquito netting, 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. It is very important that you tell your doctor about any side effect that occurs after a dose of the vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that you should not receive any more doses of the vaccine.

Get emergency help immediately if the following side effect occurs:

Rare

Swelling of face, lips, eyelids, throat, tongue, hands, or feet

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

Rare

Hives

tiredness or weakness (severe or unusual)

wheezing or troubled breathing

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Tenderness, soreness, redness, or swelling at place of injection

Less common

Abdominal pain

aches or pains in muscles

chills or fever

dizziness

general feeling of discomfort or illness

headache

itching or skin rash

nausea or vomiting

Rare

Joint swelling

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.