IXIARO Rx

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IXIARO

Vaccines
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Generic Name and Formulations:

Japanese encephalitis virus vaccine; inactivated; aluminum hydroxide adsorbed; susp for IM inj; contains formaldehyde, protamine sulfate; preservative-free.

Company:

Valneva USA

Select therapeutic use:

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: give doses 28 days apart; complete series at least 1 week before potential exposure. 2mos–<3yrs: two 0.25mL doses; ≥3yrs: two 0.5mL doses. 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.

Contraindications:

Severe allergic reaction (eg, anaphylaxis) after a previous dose.

Warnings/Precautions:

Immunocompromised. Allergy to protamine sulfate. Have appropriate medical treatment readily available. Pregnancy. Nursing mothers.

Pharmacological Class:

Japanese encephalitis vaccine.

Interactions:

Avoid concomitant injectable vaccines in the same syringe or injection site; see full labeling. Immunosuppressants may diminish immune response.

Adverse Reactions:

Inj site reactions (eg, redness, pain, tenderness), fever, irritability, diarrhea, headache; hypersensitivity reactions, syncope.

How Supplied:

Single-dose syringe (0.5mL)—1