Twinrix (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine) - Indications and Dosage

INDICATIONS AND USAGE

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.

TWINRIX will not prevent hepatitis caused by other agents such as hepatitis C virus, hepatitis E virus, or other pathogens known to infect the liver.

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 (see Table 4) who are at increased risk of HBV infection due to behavioral or occupational factors. (See CLINICAL PHARMACOLOGY.)

• 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
• Others:
  
  • Healthcare personnel who render first-aid or emergency medical assistance.
  • Personnel employed in day-care centers and correctional facilities. Residents of drug and alcohol treatment centers. Staff of hemodialysis units.
  • People living in, or relocating to, areas of high/intermediate endemicity of HAV and who have risk factors for HBV.
  • Men who have sex with men.
  • Persons at increased risk of disease due to their sexual practices. ^20,21
  • Patients frequently receiving blood products including persons who have clotting factor disorders (hemophiliacs and other recipients of therapeutic blood products).
  • Military recruits and other military personnel at increased risk for HBV.
  • 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.

DOSAGE AND ADMINISTRATION

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.

For individuals with clotting factor disorders who are at risk of hemorrhage following intramuscular injection, the ACIP recommends that when any intramuscular vaccine is indicated for such patients, ".. . it should be administered intramuscularly if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered with reasonable safety by this route. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection."²⁸

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.

Primary immunization for adults consists of 3 doses, given on a 0-, 1-, and 6-month schedule. Each 1-mL dose contains 720 EL.U. of inactivated hepatitis A virus and 20 mcg of hepatitis B surface antigen.

STORAGE

Store refrigerated between 2° and 8° C (36° and 46° F). DO NOT FREEZE ; discard if product has been frozen. Do not dilute to administer.

HOW SUPPLIED

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)