TWINRIX is indicated for active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. As with any vaccine, vaccination with TWINRIX may not protect 100% of recipients. As hepatitis D (caused by the delta virus) does not occur in the absence of HBV infection, it can be expected that hepatitis D will also be prevented by vaccination with TWINRIX.

Immunization is recommended for all susceptible persons 18 years of age or older who are, or will be, at risk of exposure to both hepatitis A and hepatitis B viruses, including but not limited to:

• Travelers: Persons traveling to areas of high/intermediate endemicity for both HAV and HBV who are at increased risk of HBV infection due to behavioral or occupational factors. (See CLINICAL PHARMACOLOGY.) Vaccine recipients should consult with CDC to determine regions of high or intermediate endemicity for hepatitis A and hepatitis B.
• Patients With Chronic Liver Disease, including: – alcoholic cirrhosis
  • chronic hepatitis C
    
  • autoimmune hepatitis
    
  • primary biliary cirrhosis
• Persons at Risk Through Their Work:
  • Laboratory workers who handle live hepatitis A and hepatitis B virus
  • Police and other personnel who render first-aid or medical assistance
  • Workers who come in contact with feces or sewage
  • Healthcare personnel who render first-aid or emergency medical assistance.
  • Personnel employed in day-care centers and correctional facilities.
  • Staff of hemodialysis units.
  • Military recruits and other military personnel at increased risk for HBV.
• Persons at Increased Risk of Disease due to Their Sexual Practices^18,19: – Men who have sex with men.
• Others:
  • Residents of drug and alcohol treatment centers.
  • People living in, or relocating to, areas of high/intermediate endemicity of HAV and who have risk factors for HBV.
  • Patients frequently receiving blood products including persons who have clotting factor disorders (hemophiliacs and other recipients of therapeutic blood products).
  • Users of injectable illicit drugs.
  • Individuals who are at increased risk for HBV infection and who are close household contacts of patients with acute or relapsing hepatitis A and individuals who are at increased risk for HAV infection and who are close household contacts of individuals with acute or chronic hepatitis B infection.

TWINRIX should be administered by intramuscular injection. Do not inject intravenously or intradermally. In adults, the injection should be given in the deltoid region. TWINRIX should not be administered in the gluteal region; such injections may result in a suboptimal response.

Primary immunization for adults consists of 3 doses, given on a 0-, 1-, and 6-month schedule. Alternatively, a 4-dose schedule, given on days 0, 7 and 21 to 30 followed by a booster dose at month 12 may be used. Each 1-mL dose contains 720 EL.U. of inactivated hepatitis A virus and 20 mcg of hepatitis B surface antigen.

When concomitant administration of other vaccines or immunoglobulin (IG) is required, they should be given with different syringes and at different injection sites.

Preparation for Administration: Shake vial or syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. With thorough agitation, TWINRIX is a slightly turbid white suspension. Discard if it appears otherwise.

The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. After removal of the appropriate volume from a single-dose vial, any vaccine remaining in the vial should be discarded.

Storage

Store TWINRIX refrigerated between 2° and 8° C (36° and 46° F). Do not freeze. Discard if the

vaccine has been frozen. Do not use after expiration date shown on the label.

TWINRIX is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK® syringes containing a 1.0-mL single dose.

Single-Dose Vials

NDC 58160-850-01 (package of 1)
NDC 58160-850-11 (package of 10)

Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-850-46 (package of 5)

References

18. Centers for Disease Control and Prevention. 1998 Guidelines for treatment of sexually transmitted diseases. MMWR 1999;47(RR-1):99-104.
19. Centers for Disease Control and Prevention. Hepatitis surveillance report No. 57. Atlanta, GA: DHHS; 2000:12.

Manufactured by GlaxoSmithKline, Rixensart, Belgium, US License No. 1617 Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

TWINRIX, HAVRIX, ENGERIX-B, and TIP-LOK are registered trademarks of GlaxoSmithKline. ENZYMUN-TEST is a registered trademark of Boehringer Mannheim Immunodiagnostics. AUSAB is a registered trademark of Abbott Laboratories.

©YEAR, GlaxoSmithKline. All rights reserved.

Bookmark this page: