Ixiaro

Ixiaro is part of the drug class:

• Encephalitis vaccines

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medicines that suppress your immune system
• Other vaccinations

This is not a complete list of Ixiaro drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ixiaro including the following:

• Severe allergic reactions from a vaccine are very rare. If one were to occur, it would usually be within a few minutes to a few hours after the vaccination. Symptoms include:
  • Difficulty breathing
  • Hoarseness or wheezing
  • Hives
  • Dizziness, weakness, or fast heartbeat

You should still protect yourself from mosquito bites even if you have had the Ixiaro vaccine.

Ixiaro may not fully protect everyone who gets the vaccine.

Ixiaro does not protect against encephalitis caused by other viruses/pathogens.

Ixiaro does not protect against other diseases transmitted by mosquitoes.

Do not receive Ixiaro if you:

• Have had a severe life-threatening allergic reaction to a dose of Ixiaro
• Have a severe life-threatening allergy to any component of Ixiaro
• Pregnant (consult with your doctor)

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is unknown if Ixiaro crosses into human milk. Because many medications and vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this vaccine, caution should be exercised if Ixiaro is administered to a nursing woman.

Since Ixiaro is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Storage

Parenteral

2–8°C;1 do not freeze.1

Store in original packaging;1 protect from light.1

• JE-VC is a sterile suspension containing purified, inactivated Japanese encephalitis virus proteins adsorbed onto aluminum hydroxide and is used to stimulate active immunity to Japanese encephalitis virus.1

• Promotes production of antibodies that neutralize live Japanese encephalitis virus.1 Data from animal studies, clinical trials of other Japanese encephalitis vaccines, and epidemiologic studies in humans suggest that a Japanese encephalitis virus-specific neutralizing antibody titer (as measured in vitro in a 50% plaque reduction neutralization test [PRNT50]) of 1:10 correlates with protective immunity against Japanese encephalitis virus infection in humans.1 2 3 6

• Following vaccination with a 2-dose primary series of JE-VC in adults ≥18 years of age residing in countries where Japanese encephalitis virus is not endemic, only 21% of vaccinees had protective levels of antibody 10 days after first dose, but 97% had protective antibody levels 7 days after second vaccine dose and still had protective antibody levels 28 days after second dose.1 Data from a study in adults residing in nonendemic countries indicate that protective levels of antibody persist for 6, 12, 24, and 36 months in 95, 83, 82, and 85%, respectively, of those who receive a 2-dose primary series of JE-VC.1

• Following vaccination with an age-appropriate 2-dose primary series of JE-VC in infants and children 2 months through 17 years of age residing in nonendemic countries, 100% had protective antibody levels when evaluated 56 days and 7 months later.1

• A single booster dose of JE-VC given 14–24 months after completion of 2-dose primary series elicits a booster response in adults.1 6 Data from a study in adults residing in nonendemic countries who received a single booster dose of JE-VC 14 months after completion of the 2-dose primary series indicate that the proportion of these adults with protective antibody levels increased from 69% immediately prior to the booster dose to 100% at 28 days after the booster dose;1 99% still had protective antibody levels 12 months after the booster dose.1

• Although further study needed, administration of JE-VC in adults who previously received primary vaccination with inactivated mouse brain-derived Japanese encephalitis vaccine (JE-MB; no longer available in the US but may be available in other countries) results in a booster response.9 10

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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 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.

If you received the second dose of the vaccine series more than 1 year ago, talk to your doctor. You may need a booster dose before you travel out of the country.

This vaccine comes with a patient information sheet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

It is very important that you receive the second dose of the vaccine series at the right time.

This vaccine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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.

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.