Twinrix

GlaxoSmithKline
  • Indications and Usage

    TWINRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older.

  • Dosage and Administration

    • TWINRIX is administered by intramuscular injection.
    • Standard Dosing: A series of 3 doses (1 mL each) given on a 0-, 1-, and 6-month schedule.
    • Accelerated Dosing: A series of 4 doses (1 mL each) given on days 0, 7, and 21 to 30 followed by a booster dose at month 12.
  • Dosage Forms and Strengths

    Suspension for injection available in 1-mL single-dose vials and prefilled syringes.

  • Contraindications

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

  • Warnings and Precaution

    • TWINRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals.
    • Syncope (fainting) can occur in association with administration of injectable vaccines, including TWINRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
  • Adverse Reactions

    Following any dose of TWINRIX, the most common (<10%) solicited injection site reactions were injection site soreness (35% to 41%) and redness (8% to 11%); the most common solicited systemic adverse events were headache (13% to 22%) and fatigue (11% to 14%).

  • Use in Specific Populations

    Safety and effectiveness of TWINRIX have not been established in pregnant women, nursing mothers, and pediatric patients.