Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 April 2017

Indication(s)

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. (1)

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Advisory information

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. (4)

Special warnings and precautions

• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.1)
• 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. (5.2)

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%). (6.1)

Usage information

Dosing and administration

• TWINRIX is administered by intramuscular injection. (2.2)
• Standard Dosing: A series of 3 doses (1 mL each) given on a 0-, 1-, and 6-month schedule. (2.3)
• 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. (2.3)

Use in special populations

• Safety and effectiveness of TWINRIX have not been established in pregnant women, nursing mothers, and pediatric patients. (8.1, 8.3, 8.4)

Interactions

Do not mix TWINRIX with any other vaccine or product in the same syringe or vial. (7.1)

More information

Category Value
Authorisation number BLA103850
Orphan designation No
Product NDC 58160-815
Date First Approved 07-06-2007
Marketing authorisation holder GlaxoSmithKline Biologicals