Generic Name and Formulations:
Japanese encephalitis virus vaccine; inactivated; aluminum hydroxide adsorbed; susp for IM inj; contains formaldehyde, protamine sulfate; preservative-free.
Indications for IXIARO:
Japanese encephalitis virus (JEV) immunization in patients ≥2mos of age.
Adults and Children:
<2mos: not established. Give only by IM inj into anterolateral aspect of the thigh (2mos–<3yrs) or the deltoid muscle (≥3yrs; for 1–<3yrs if muscle mass adequate). Primary series: complete series at least 1 week before potential exposure. 2mos–<3yrs: two 0.25mL doses, given 28 days apart; 3–<18yrs: two 0.5mL doses, given 28 days apart; 18–65yrs: two 0.5mL doses, given either 7 days or 28 days apart; >65yrs: two 0.5mL doses, given 28 days apart. Booster dose (3rd dose): may give at least 11mos after completing the primary series if JEV risks remain; (14mos–<3yrs): one 0.25mL dose; (≥3yrs): one 0.5mL dose.
Severe allergic reaction (eg, anaphylaxis) after a previous dose.
Immunocompromised. Allergy to protamine sulfate. Have appropriate medical treatment readily available. Pregnancy. Nursing mothers.
Japanese encephalitis vaccine.
Avoid concomitant injectable vaccines in the same syringe or injection site; see full labeling. Immunosuppressants may diminish immune response.
Inj site reactions (eg, redness, pain, tenderness), fever, irritability, diarrhea, headache, myalgia; hypersensitivity reactions, syncope.
Single-dose syringe (0.5mL)—1