INDICATIONS AND USAGE

HAVRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus (HAV) for persons ≥12 months of age. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. (1)

 

DOSAGE AND ADMINISTRATION

• Children and adolescents: A single intramuscular 0.5-mL dose and a 0.5-mL booster dose administered between 6 and 12 months later. (2.2)
• Adults: A single intramuscular 1-mL dose and a 1-mL booster dose administered between 6 and 12 months later. (2.2)

DOSAGE FORMS AND STRENGTHS

• HAVRIX is a suspension in single-dose vials and prefilled syringes. (3)
• Each 0.5-mL pediatric dose of vaccine consists of 720 EL.U. of viral antigen. (3)
• Each 1-mL adult dose of vaccine consists of 1440 EL.U. of viral antigen. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin. (4)

 

WARNINGS AND PRECAUTIONS

• The needleless prefilled syringes contain dry natural latex rubber and may cause allergic reactions. (5.1)
• Immunocompromised persons may have a diminished immune response to HAVRIX. (5.2)

ADVERSE REACTIONS

The most common solicited adverse events were injection-site soreness (56% of adults and 21% of children) and headache (14% of adults and less than 9% of children). (6.1)

 

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

• Do not mix HAVRIX with any other vaccine or product in the same syringe or vial.
• HAVRIX may be given concurrently at different injection sites with:
  • Haemophilus influenzae type b (Hib) conjugate vaccine (PRP-T) in children 15 to 18 months of age
  • the fourth dose of pneumococcal 7-valent conjugate vaccine in children 15 months of age
  • immune globulin. (7.1)

USE IN SPECIFIC POPULATIONS

Safety and effectiveness of HAVRIX have not been established in children less than 12 months of age, pregnant women and nursing mothers. (8.4)

 

Revised: August 2009

HVX:26PI

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

2.2 Recommended Dose and Schedule

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Latex

5.2 Altered Immunocompetence

5.3 Limitations of Vaccine Effectiveness

5.4 Preventing and Managing Allergic

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