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Je-Vax

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Je-Vax

Indications
Dosage
How Supplied

INDICATIONS

JE-VAX (japanese encephalitis virus vaccine inactivated) is indicated for active immunization against JE for persons one year of age and older. For recommended primary immunization series see DOSAGE AND ADMINISTRATION section.

JE-VAX should be considered for use in persons who plan to reside in or travel to areas where JE is endemic or epidemic during a transmission season. JE-VAX (japanese encephalitis virus vaccine inactivated) is NOT recommended for all persons traveling to or residing in Asia. The incidence of JE in the location of intended stay, the conditions of housing, nature of activities, duration of stay, and the possibility of unexpected travel to high-risk areas are factors that should be considered in the decision to administer vaccine. In general, vaccine should be considered for use in persons spending a month or longer in epidemic or endemic areas during the transmission season, especially if travel will include rural areas. Depending on the epidemic circumstances, vaccine should be considered for persons spending less than 30 days whose activities, such as extensive outdoor activities in rural areas, place them at particularly high risk for exposure.1

In all instances, travelers are advised to take personal precautions to reduce exposure to mosquito bites. (See INFORMATION FOR PATIENTS section.)

Current CDC advisories should be consulted with regard to JE epidemicity in specific locales.1

The decision to use JE-VAX (japanese encephalitis virus vaccine inactivated) should balance the risks for exposure to the virus and for developing illness, the availability and acceptability of repellents and other alternative measures, and the side effects of vaccination. Assessments should be interpreted cautiously because risk can vary within areas and from year to year and available data are incomplete. Estimates suggest that risk of JE in highly endemic areas during the transmission season can reach 1 per 5,000 per month of exposure; risk for most short-term travelers may be 1 per million or less. Although JE vaccine is reactogenic, rates of serious allergic reactions (generalized urticaria and/or angioedema) are low (approximately 1-104 per 10,000).1

Advanced age may be a risk factor for developing symptomatic illness after infection. JE acquired during pregnancy carries the potential for intrauterine infection and fetal death. These factors should be considered when advising elderly persons and pregnant women who plan visits to JE endemic areas.

There are no data on the safety and efficacy of JE vaccine in infants under one year of age. Whenever possible, immunization of infants should be deferred until they are one year of age or older.1

Research laboratory workers

Laboratory acquired JE has been reported in 22 cases. JE virus may be transmitted in a laboratory setting through needle sticks and other accidental exposures. Vaccine-derived immunity presumably protects against exposure through these percutaneous routes. Exposure to aerosolized JE virus, and particularly to high concentrations of virus, such as may occur during viral purification, potentially could lead to infection through mucous membranes and possibly directly into the central nervous system through the olfactory mucosa. It is unknown whether vaccine-derived immunity protects against such exposures, but immunization is recommended for all laboratory workers with a potential for exposure to infectious JE virus.1

As with any vaccine, vaccination with JE-VAX (japanese encephalitis virus vaccine inactivated) may not result in protection in all individuals. Long-term protection, as demonstrated by persistence of neutralizing antibody for more than two years, has not yet been shown.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

For persons 3 years of age and older, a single dose is 1.0 mL of vaccine. For children 1 year to 3 years of age, a single dose is 0.5 mL of vaccine. (See PRIMARY IMMUNIZATION SCHEDULE below.)

Single-Dose vial of lyophilized vaccine: Remove plastic tab of flip-off cap. DO NOT REMOVE RUBBER STOPPER. Cleanse stopper with a suitable disinfectant. Reconstitute only with the supplied 1.3 mL of diluent (Sterile Water for Injection). Shake vial thoroughly. After reconstitution the vaccine should be stored at 2° to 8°C (35° to 46°F) and used within 8 hours. DO NOT FREEZE RECONSTITUTED VACCINE.

The vaccine is to be given by subcutaneous administration only.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

SHAKE VIAL WELL.

PRIMARY IMMUNIZATION SCHEDULE1

The recommended primary immunization series is three doses of 1.0 mL each for individuals > 3 years of age given subcutaneously on days 0, 7, and 30. For children 1 to 3 years of age a series of three doses of 0.5 mL each should be given subcutaneously on days 0, 7, and 30. An abbreviated schedule of days 0, 7, and 14 can be used when the longer schedule is impractical because of time constraints. (When it is impossible to follow one of the above recommended schedules, two doses given a week apart will induce antibodies in approximately 80% of vaccinees; however, this two-dose regimen should not be used except under unusual circumstances.) The last dose should be given at least 10 days before the commencement of international travel to ensure an adequate immune response and access to medical care in the event of delayed adverse reactions.

A booster dose of 1.0 mL (0.5 mL for children from 1 to 3 years of age) may be given after two years. In the absence of firm data on the persistence of antibody after primary immunization, a definite recommendation cannot be made on the spacing of boosters beyond two years.

There are no data on the safety and efficacy of JE vaccine in infants under one year of age. Whenever possible, immunization of infants should be deferred until they are one year of age or older.1

The skin at the site of injection first should be cleansed and disinfected. Shake vial thoroughly before each use. Cleanse top of rubber stopper of the vial with a suitable antiseptic and wipe away all excess before withdrawing vaccine.

When JE-VAX (japanese encephalitis virus vaccine inactivated) and any other vaccines are given concurrently, separate syringes and separate sites should be used.

HOW SUPPLIED

Vial, Single Dose (3 per package) with vial of Diluent (3 per package) - Product No. 49281-680-30

CPT® Code: 90735

CPT is a registered trademark of the American Medical Association.

For persons 3 years of age and older, a single dose is 1.0 mL of vaccine. For children 1 year to 3 years of age, a single dose is 0.5 mL of vaccine. (See PRIMARY IMMUNIZATION SCHEDULE above.)

Storage

The vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. After reconstitution the vaccine should be stored at 2° to 8°C (35° to 46°F) and used within 8 hours. DO NOT FREEZE RECONSTITUTED VACCINE.

REFERENCES

1. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Inactivated Japanese Encephalitis Virus Vaccine. MMWR 42: 1-15, 1993

Manufactured by: The Research Foundation for Microbial Diseases of Osaka University Suita, Osaka, Japan. Distributed by: Sanofi Pasteur Inc. Swiftwater, PA 18370, USA. Product Information 1-800-VACCINE (1-800-822-2463). As of December 2005. FDA Rev date: n/a

Last reviewed on RxList: 11/4/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
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