Japanese encephalitis virus vaccine (Intramuscular)

Japanese encephalitis virus vaccine, inactivated, adsorbed (Ixiaro®) is used to prevent infection from the Japanese encephalitis virus. It helps your body make its own protection (antibodies) against the virus.

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

It is very important that you get the second dose of the vaccine series on time. You may not be fully protected 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 needs 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 getting the vaccine.

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

Since the vaccine may not protect everyone completely, it is very important to take 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor need to consider the risks of taking the vaccine against the benefits it may provide. For this vaccine, please consider the following:

Allergies

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

Pediatric

Appropriate studies have not been performed to determine how age affects the results of Japanese encephalitis virus vaccine, inactivated, adsorbed in children younger than 2 months old. Safety and effectiveness have not been established.

Geriatric

Appropriate studies conducted to date have not shown any specific problems in elderly patients that would limit the usefulness of Japanese encephalitis virus vaccine, inactivated, adsorbed.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When receiving this vaccine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this vaccine with any of the following medicines is generally not recommended, but may be necessary in certain cases. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical problems, especially:

• Bleeding disorder (e.g., thrombocytopenia)—Use with caution. May increase the risk of bleeding or bruising.

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

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

Check with your doctor or nurse right away 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.

In the U.S.

• Ixiaro

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

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.