Japanese encephalitis virus vaccine (Rx)

Brand and Other Names:Ixiaro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

suspension for IM injection

  • 0.5mL prefilled syringe
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Active Immunization

Vaccine recommended for adults at increased risk of Japanese encephalitis virus (JEV) during travel to Asia

Complete primary immunization series at least 1 week prior to potential exposure to JEV

18 through 65 years: 2 doses (0.5 mL) administered either 7 or 28 days apart

≥66 years: 2 doses (0.5 mL) IM administered 28 days apart

Booster dose

  • A single 5-mL booster dose (third dose) may be given at least 11 months after completing the primary immunization series if ongoing exposure or re-exposure to JEV is expected

Dosage Forms & Strengths

suspension for IM injection

  • 0.5mL prefilled syringe
more...

Active Immunization

Vaccine recommended for adults and children aged ≥2 months at increased risk of Japanese encephalitis virus (JEV) during travel to Asia

<2 months: Safety and efficacy not established

Complete all immunization at least 1 week prior to potential exposure to JEV

Primary immunization series

  • 2 months to <3 years: 2 doses (0.25 mL) IM administered 28 days apart
  • ≥3 years: 2 doses (0.5 mL) IM administered 28 days apart

Booster dose

  • A booster dose (third dose) may be given at least 11 months after completing the primary immunization series if ongoing exposure or re-exposure to JEV is expected
  • 14 months to <3 years: Administer a single 0.25-mL booster dose
  • ≥3 years: Administer a single 0.5-mL booster dose
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Interactions

Interaction Checker

and Japanese encephalitis virus vaccine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            >10%

            Infants 2 month to <1 year

            • Injection site redness (5.3-17.6%)
            • Irritability (8.4-15.3%)
            • Fever, 99.9-101.5°F (12.2-17.6%)
            • Diarrhea (8.4-11.5%)

            Children 1 year to <3 years

            • Fever, 99.9-101.5F (8.5-15.6%)

            Adolescents 12 years to <18 years

            • Injection pain (6.7-15%)

            Adults ≥18 years

            • Headache (27.9%)
            • Myalgia (15.6%)
            • Influenzalike illness (12.3%)
            • Fatigue (11.3%)

            1-10%

            Infants 2 month to <1 year

            • Rash (3.8-8.4%)
            • Vomiting (3.8-7.6%)
            • Fever, 101.6-102.7°F (1.5-6.1%)
            • Loss of appetite (5.3%)
            • Excessive fatigue (1.5-3.1%)
            • Injection site tenderness (0.8-3.1%)
            • Injection site swelling (1.5%)

            Children 1 year to <3 years

            • Flulike symptoms (4-7.7%)
            • Irritability (2.7-7.7%)
            • Diarrhea (4.6-7%)
            • Injection site redness (2.5-6.1%)
            • Loss of appetite (2.5-5.6%)
            • Vomiting (2.8-4.2%)
            • Rash (1.3-4.2%)
            • Injection site pain (3.6%)
            • Injection site tenderness or swelling (1.4-3.1%)
            • Fever, 101.6-102.7°F (2.5-3%)
            • Excessive fatigue (1.1-2.5%)
            • Muscle pain (0.7-2.3%)
            • Nausea (0.9-2.2%)
            • Fever, 102.8-104.9°F (1.6%)
            • Headache (1.4-1.5%)

            Children 3 years to <12 years

            • Fever, 99.9-101.5°F (3.3-7.7%)
            • Injection site pain or tenderness (1.7-5.5%)
            • Headache (1.4-3.8%)
            • Injection site itching, hardening, swelling, or redness (0.7-3%)
            • Muscle pain (0.3-2.4%)
            • Fever, 101.6-102.7°F (0.7-2%)
            • Vomiting (0.7-1.7%)
            • Flulike symptoms (0.3-1.4%)
            • Rash (1%)
            • Loss of appetite (1%)
            • Fever, 102.8-104.9°F (0.7-1%)
            • Excessive fatigue (0.7-1%)

            Adolescents 12 years to <18 years

            • Injection site tenderness (0.4-10%)
            • Headache (3.4-4.6%)
            • Fever, 99.9-101.5°F (3.3-3.8%)
            • Flulike symptoms (1.3-3.3%)
            • Muscle pain (1.3-2.9%)
            • Excessive fatigue (0.4-2.5%)
            • Irritability (2.1%)
            • Nausea (2.1%)
            • Loss of appetite (0.4-2.1%)
            • Vomiting (1.3%)
            • Fever, 101.6-102.7°F (0.4-1.3%)
            • Injection site hardening (0.4-1.3%)

            Adults ≥18 years

            • Nausea (6.6%)
            • Nasopharyngitis (4.7%)
            • Fever (3.2%)
            • URI (1.7%)
            • Pharyngolaryngeal pain (1.6%)
            • Diarrhea (1.5%)
            • Rhinitis (1.4%)
            • Vomiting (1.4%)
            • Back pain (1.3%)
            • Rash (1.3%)
            • Cough (1.2%)

            <1%

            Infants 2 month to <1 year

            • Fever, 102.8-104.9°F (0.8%)

            Children 1 year to <3 years

            • Fever, >104.9°F (0.2%)

            Postmarketing Reports

            Nervous system disorders: Paraesthesia, neuritis, syncope

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            Warnings

            Contraindications

            Severe allergic reaction (eg, anaphylaxis) after previous dose, another Japanese encephalitis virus vaccine, or any component, including protamine sulfate; if history uncertain, refer to allergist

            Cautions

            Contains protamine sulfate, potentially allergenic (see Contraindications)

            Syncope can occur in association with administration of injectable vaccines; follow procedures to avoid falling injury and to restore cerebral perfusion following syncope

            Limitations of vaccine effectiveness; vaccination may not protect all individuals

            Immunocompromised individuals may have a diminished immune response; immunosuppressive therapies may decrease immune response to JEV

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            Pregnancy & Lactation

            Pregnancy

            Data are not available to establish the presence or absence of drug-associated risk during pregnancy

            Healthcare practitioners are encouraged to report use in pregnant women to the distributor, Valneva USA, Inc., at 844-349-4276

            Disease-associated maternal and/or embryo/fetal risk: Miscarriages and intrauterine infection have been reported following maternal infection with JEV

            Lactation

            Unknown if excreted in human milk

            The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            JE virus antigen, inactivated adsorbed

            These products convey active immunity via stimulation of production of endogenously produced antibodies

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            Administration

            IM Preparation

            During storage, a clear liquid with a white precipitate can be observed; shake syringe well to obtain a white, opaque, homogeneous suspension

            Inspected visually for particulate matter and discoloration prior to administration

            0.25-mL dose preparation

            • Shake the prefilled syringe containing 0.5 mL to obtain homogenous suspension
            • Remove the syringe tip cap by gently twisting it; do not attempt to snap or pull the tip off as this may damage the syringe
            • Attach a sterile safety needle to the prefilled syringe (needle is not provided)
            • Hold the syringe in an upright position and uncap the needle
            • Push the plunger stopper to the edge of the red line on the syringe barrel and discard expelled volume into medical waste container
            • Lock the needle safety shield and remove the needle
            • Attach a new sterile needle prior to injection of the remaining volume

            0.5-mL dose preparation

            • Shake the prefilled syringe containing 0.5 mL to obtain homogenous suspension
            • Remove the syringe tip cap by gently twisting it; do not attempt to snap or pull the tip off as this may damage the syringe
            • Attach a sterile safety needle to the prefilled syringe (needle is not provided)

            IM Administration

            For IM administration only; do not administer IV, SC, or ID

            When JEV is concomitantly used with injectable vaccines, separate syringes at different injection sites; do not be mixed with any other vaccine in the same syringe or vial

            Administration sites

            • Aged 2-11 months: Anterolateral aspect of the thigh
            • Aged 1 to <3 years: Anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate)
            • Aged ≥3 years: Deltoid muscle

            Storage

            Prefilled syringe: Store refrigerated between 2-8°C (35-46°F)

            Do not freeze

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.