Japanese encephalitis vaccine (inactivated, adsorbed)

Japanese encephalitis vaccine (inactivated, adsorbed) is used for: Japanese encephalitis virus infection

Intramuscular Injection Active Immunization Indicated for active immunization for the prevention of disease caused by Japanese encephalitis virus (JEV). Vaccine recommended for adults at increased risk of Japanese encephalitis virus (JEV) during travel to Asia Primary Series 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

Intramuscular Injection 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 immunizations 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

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

Severe allergic reaction (eg, anaphylaxis) after previous dose, another Japanese encephalitis virus vaccine, or any component, including protamine sulfate

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 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

Immunosuppressive therapies may decrease the immune response to Japanese encephalitis vaccine Contraindicated (0) Serious (41) adalimumab alefacept anakinra antithymocyte globulin equine antithymocyte globulin rabbit atidarsagene autotemcel azathioprine basiliximab budesonide canakinumab cortisone deflazacort dexamethasone elivaldogene autotemcel etanercept everolimus fludrocortisone glatiramer golimumab hydrocortisone hydroxychloroquine sulfate infliximab leflunomide methylprednisolone muromonab CD3 mycophenolate ocrelizumab ocrelizumab/hyaluronidase ofatumumab SC prednisolone prednisone rilonacept secukinumab siponimod sirolimus tacrolimus temsirolimus teplizumab tocilizumab triamcinolone acetonide injectable suspension ustekinumab

Side effects of Japanese encephalitis vaccine (inactivated, adsorbed) : >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%)

JE virus antigen, inactivated adsorbed These products convey active immunity via stimulation of the production of endogenously produced antibodies