VAQTA VACCINE 50U/ml

II. INDICATIONS

VAQTA is indicated for active pre-exposure prophylaxis against disease caused by HAV.

VAQTA is recommended for healthy individuals from 12 months of age and older who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g., hepatitis C with diagnosed liver disease, adults with Human Immunodeficiency Virus [HIV]).

V. CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine.

III. DOSAGE AND ADMINISTRATION

DO NOT INJECT INTRAVASCULARLY OR INTRADERMALLY

VAQTA is for intramuscular injection. For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.

Adults with Bleeding Disorders

For individuals with bleeding disorders who are at risk of hemorrhage following intramuscular injection (e.g., hemophiliacs), this vaccine can be administered subcutaneously (See PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The vaccination series consists of one primary dose and one booster dose given according to the following schedule:

Children/Adolescents – 12 Months Through 17 Years of Age

Individuals 12 months through 17 years of age should receive a single 0.5 mL (25 units) dose of vaccine at elected date and a booster dose of 0.5 mL (25 units) 6 to 18 months later.

Adults

Adults 18 years of age and older should receive a single 1.0 mL (50 units) dose of vaccine at elected date and a booster dose of 1.0 mL (50 units) 6 to 18 months later.

Adults With Human Immunodeficiency Virus (HIV)

HIV-infected adults should receive a single 1.0 mL (50 units) dose of vaccine at elected date and a booster dose of 1.0 mL (50 units) 6 months later.

Interchangeability of the Booster Dose

A booster dose of VAQTA may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines.

Use With Other Vaccines

VAQTA may be given concomitantly with yellow fever, typhoid, measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzae b vaccines. Data on concomitant use with other vaccines are limited. (See DRUG INTERACTIONS, Use With Other Vaccines – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

Separate injection sites and syringes should be used for concomitant administration of injectable vaccines.

Known or Presumed Exposure to HAV/Travel to Endemic Areas

Use With Immune Globulin

VAQTA may be administered concomitantly with IG using separate sites and syringes. The vaccination regimen for VAQTA should be followed as stated above. Consult the manufacturer’s product circular for the appropriate dosage of IG. A booster dose of VAQTA should be administered at the appropriate time as outlined above (see DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. After thorough agitation, VAQTA is a slightly opaque, white suspension.

It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one person to another.