Pronunciation:

jap-a-NEEZ en-sef-a-LYTE-is VYE-rus VAX-een, 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®) 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.

This vaccine is to be given only by or under the direct supervision of your doctor.

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 younger than 2 months 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.

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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

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 disorder (eg, thrombocytopenia)—Use with caution. May increase risk of bleeding or bruising.

• 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. It is given as a shot into the muscle of your upper arm or thigh.

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.

You may need a booster dose if you continue to be exposed to the virus or might be exposed again. Get the booster dose at least 11 months after your last scheduled dose. You may need a booster dose if you continue to be exposed to the virus or might be exposed again. Get the booster dose at least 11 months after your last scheduled dose.You may also need a booster dose if you received the second dose of the vaccine series more than 1 year ago.

This vaccine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that you receive the second dose of the vaccine series at the right time. You may not be protected as well until 1 week after you receive the second dose of the vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

This vaccine may case syncope (fainting). Talk with your doctor if you have concerns.

Since the vaccine may not protect everyone completely, it is very important that you use precautions to reduce the risk of mosquito bites. Use insect repellents and mosquito nets, wear protective clothing, and stay indoors during twilight and after dark.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 or nurse 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 breathing

ear congestion

loss of voice

nasal congestion

sneezing

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

fainting

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 moving

muscle cramps or stiffness

swollen joints

Less common

Back pain

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

rash

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.