with concomitant live vaccines.temsirolimusSerious - Use Alternative (1)temsirolimus decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.teplizumabSerious - Use Alternative (1)teplizumab decreases effects of Japanese encephalitis virus vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.tocilizumabSerious - Use Alternative (1)tocilizumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tralokinumabMonitor Closely (1)tralokinumab will decrease the level or effect of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.triamcinolone acetonide injectable suspensionSerious - Use Alternative (1)triamcinolone acetonide injectable suspension decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.ublituximabMonitor Closely (1)ublituximab decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.ustekinumabSerious - Use Alternative (1)ustekinumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.voclosporinMonitor Closely (1)voclosporin decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. 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 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 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 conditionPregnancy 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. Mechanism of Action JE virus antigen, inactivated adsorbed These products convey active immunity via stimulation of production of endogenously produced antibodies 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding 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.Create Your List of PlansAdding 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. View explanations for tiers and restrictions 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. 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