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


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)

Full Prescribing information

Learning Zones

An Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.



See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Inflammatory Bowel Disease Knowledge Centre

Inflammatory Bowel Disease Knowledge Centre

The Inflammatory Bowel Disease (IBD) Knowledge Centre contains key information relating to the epidemiology and pathophysiology of Crohn’s disease and ulcerative colitis, highlighting prevalence, impact and unmet needs and the underlying inflammatory processes that drive IBD, considering some of the key inflammatory pathways.

Inflammatory bowel disease assessment tools

Inflammatory bowel disease assessment tools

'New IBD assessment tools at a glance' - an educational symposium sponsored by Sandoz.

Load more

Related Content

Advisory information


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)


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