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.
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.
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.