Ixiaro (Japanese encephalitis vaccine/PF)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Japanese encephalitis vaccine inactivated adsorbed (JE-VC) is an inactivated Vero cell culture-derived vaccine containing inactivated Japanese encephalitis virus. This is the only Japanese encephalitis vaccine available in the US; other types of Japanese encephalitis vaccines may be available in other countries (e.g., live attenuated vaccine, live recombinant chimeric vaccine, inactivated mouse brain-derived vaccine).
Japanese encephalitis vaccine inactivated adsorbed (JE-VC) is a sterile suspension of purified, inactivated Japanese encephalitis virus proteins adsorbed onto aluminum hydroxide and is used to stimulate active immunity to Japanese encephalitis virus.
JE-VC promotes production of antibodies that neutralize live Japanese encephalitis virus. 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.
JE-VC is prepared by propagating Japanese encephalitis virus strain SA14-14-2 in Vero cells. After the virus is harvested, pooled, clarified, and concentrated, the virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins and the partially purified virus is then processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of the virus; fractions with the highest virus activity are pooled to give a purified virus suspension.
After the purified virus is inactivated with formaldehyde, the preparation is adjusted to a specified protein concentration and formulated by adding an aluminum hydroxide adjuvant.
Each 0.5-mL dose of JE-VC contains 6 mcg of purified, inactivated Japanese encephalitis virus proteins and 250 mcg of aluminum hydroxide. Each 0.5-mL dose of the vaccine also contains formaldehyde (not exceeding 200 ppm), bovine serum albumin (not exceeding 100 ng/mL), host cell DNA (not exceeding 200 pg/mL), sodium metabisulfite (not exceeding 200 ppm), host cell protein (not more than 100 ng/mL), and protamine sulfate (not exceeding 1 mcg/mL) from the manufacturing process.
USES: This vaccine is used to help prevent disease caused by the Japanese encephalitis virus. It works by increasing the body's natural defense (immunity) against the virus. This vaccine is recommended for people who live in or are traveling to areas where the infection is common and those who work with the virus in a lab.
Vaccines may not fully protect everyone who receives them.
Generic name: Japanese encephalitis vaccine/PF
Pronunciation: (jap-uh-NEEZ en-sef-uh-LY-tis)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Ixiaro
Indications
The following indications are listed for Ixiaro:
- Japanese Encephalitis Vaccination
Also known as: Active Immunization Against Japanese Encephalitis Virus, Active Immunization Against Jev, Prevention Of Japanese B Encephalitis Virus Disease, Prevention Of Japanese Encephalitis Virus Disease.
Dosing
No dosing information is available for this tab.
Japanese encephalitis vaccine inactivated adsorbed (JE-VC) is administered by IM injection. The vaccine should not be given IV, intradermally, or subcutaneously. JE-VC is commercially available as a sterile 0.5 mL suspension supplied in a prefilled single-dose syringe.
Depending on patient age, IM injections of JE-VC should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm. In pediatric patients 2-11 months of age, IM injections should preferably be made into the anterolateral thigh; alternatively, the deltoid muscle can be used in those 1 to <3 years of age if muscle mass is adequate. In adults, adolescents, and children 3 years of age or older, IM injections should preferably be made into the deltoid muscle.
Before agitation, JE-VC appears as a clear fluid with a white precipitate. Immediately prior to administration, the syringe containing JE-VC should be shaken well to obtain a white, opaque, homogeneous suspension. The vaccine should not be administered if it is discolored or contains particulate matter.
After shaking, a sterile needle should be attached to the prefilled syringe. For adults, adolescents, and children 3 years of age or older, the entire contents of the syringe (0.5 mL) should be administered IM. To provide the appropriate dose for pediatric patients 2 months through <3 years of age, the indicated portion of the syringe contents should be expelled through the needle into a medical waste container according to the manufacturer's directions; the needle should then be replaced with a new sterile needle and the remaining volume of vaccine in the syringe should be administered IM to the pediatric patient. JE-VC should not be mixed with any other vaccine in the same syringe or vial.
Store JE-VC under refrigeration at 2-8degreesC and do not freeze. Do not use the vaccine beyond the expiration date printed on the label. Keep the vaccine in the original packaging to protect it from light. During storage, the vaccine may appear as a clear liquid with a white precipitate.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Severe allergic reaction (e.g., anaphylaxis) to a previous dose of the vaccine or any component of the vaccine (e.g., protamine sulfate).
*Severe allergic reaction to any other Japanese encephalitis vaccine.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects following a dose of JE-VC in pediatric patients 2 months through <1 year of age are injection site reaction (e.g., redness), fever, irritability, and diarrhea.
In pediatric patients 1 to <3 years of age and those 3 to <12 years of age, fever is the most frequently reported systemic reaction.
Among pediatric patients 12 to <18 years of age, the most common injection site reactions are pain and tenderness.
In adults 18 years of age and older, the most frequent injection site reactions are pain and tenderness, while the most common systemic reactions are headache and muscle pain.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of JE-VC have not been established in pediatric patients younger than 2 months of age.
There are no adequate and well-controlled studies using JE-VC in pregnant women. In animal studies (female rats), administration of JE-VC at dosages approximately 300-fold higher than the projected human dosage (on a mg/kg basis) did not reveal evidence of impaired fertility or harm to the fetus.
JE-VC should be used during pregnancy only if clearly needed.
Clinicians are encouraged to report cases of inadvertent administration of JE-VC during pregnancy to 1-844-349-4276 (8443-IXIARO).
It is not known whether JE-VC is distributed into human milk.
JE-VC should be used with caution in nursing women.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Clinical studies did not include sufficient numbers of adults 65 years of age and older to determine whether they respond differently to JE-VC than younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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