IMPORTANT INFORMATION ABOUT
TWINRIX® (Combined Hepatitis A and B) VACCINE
Please Read Carefully
WHAT IS HEPATITIS A?
Hepatitis A is a serious liver disease caused by the hepatitis A virus (HAV). HAV is found in the
stool of persons with hepatitis A. It is usually spread by close personal contact and sometimes
by eating food or drinking water containing HAV. Hepatitis A can cause mild “flu-like” illness,
jaundice (yellow skin or eyes) and severe stomach pains and diarrhea. People with hepatitis A
often have to be hospitalized (up to about 1 person in 5). Sometimes, hepatitis A causes death
(about 100 per year in the U.S.). A person who has hepatitis A can easily pass the disease to
others within the same household. Hepatitis A vaccine can prevent hepatitis A.
WHAT IS HEPATITIS B?
Hepatitis B is a serious disease. The hepatitis B virus (HBV) can cause short-term (acute)
illness that leads to loss of appetite, diarrhea and vomiting, tiredness, jaundice (yellow skin or
eyes), and pain in muscles, joints, and stomach. It can also cause long-term (chronic) illness
that leads to liver damage (cirrhosis), liver cancer and death. About 1.25 million people in the
U.S. have chronic HBV infection. Each year it is estimated that 80,000 people, mostly young
adults, get infected with HBV; more than 11,000 people have to stay in the hospital because of
hepatitis B and 4,000 to 5,000 people die from chronic hepatitis B. Hepatitis B vaccine can
prevent hepatitis B. It is the first anti-cancer vaccine because it can prevent a form of liver
cancer.
COMBINED HEPATITIS A AND B VACCINE (TWINRIX®):
Twinrix® is a combined hepatitis A and B vaccine licensed for people age 18 years and older.
The two components in Twinrix have been used routinely in separate single antigen vaccines in
the United States since 1995 and 1989 as hepatitis A and B vaccines, respectively.
Each dose of Twinrix also contains aluminum hydroxide and aluminum phosphate as adjuvants,
2-phenoxyethanol as a preservative, and pH stabilizer in normal saline. Twinrix prefilled
syringes may contain latex in the tip cap.
Twinrix provides protection against both hepatitis A virus (HAV) or hepatitis B virus (HBV) in
patients 18 years of age and older. Because hepatitis D (caused by the delta virus) occurs only
in people with HBV infection, hepatitis D will also be prevented by this vaccine.
PREGNANCY: Animal reproduction studies have not been conducted with Twinrix. It is not
known if this vaccine crosses the placenta. Generally, most IgG passage across the placenta
occurs during the third trimester. Problems in humans have not been documented and are
unlikely.
BREASTFEEDING: It is not known if this vaccine crosses into human breast milk. Problems in
humans have not been documented and are unlikely.
IMMUNIZATION SCHEDULE:
The schedule for Twinrix vaccine is three doses, given on a 0-, 1-, and 6-month schedule, the
same schedule as that used for single antigen hepatitis B vaccine. Because the vaccine uses a
pediatric dose of hepatitis A vaccine, all three doses must be given as Twinrix, or additional
adult doses of single-antigen hepatitis A will be needed to provide complete protection against
hepatitis A.
In April 2007, the FDA approved an accelerated schedule of four doses given at the initial visit,
day 7, and between 21-30 days, and a final dose one year later.
WHO SHOULD GET THE VACCINE:
Twinrix is recommended for all susceptible people 18 years of age and older who are or will be
at risk of exposure to hepatitis A and B viruses, including, but not limited to the following:
 Travelers to areas with high or intermediate rates of both hepatitis A and hepatitis B
viruses. Hepatitis B protection is recommended for travelers who plan to stay for 6
months or more and have frequent close contact with the local population.
 Patients with chronic liver disease, including alcoholic cirrhosis, chronic hepatitis C
infection, autoimmune hepatitis, or primary biliary cirrhosis.
 People at risk through their work, such as laboratory workers who handle live hepatitis A
and hepatitis B virus.
 Residents of drug and alcohol treatment centers
 Patients and staff of hemodialysis units
 Men who have sex with men
 Persons with clotting factor disorders who receive therapeutic blood products
 Users of illicit injectable drugs
POSSIBLE SIDE EFFECTS FROM THE VACCINE:
The risk of Twinrix® vaccine causing serious harm, or death, is extremely small. Getting
Twinrix® vaccine is much safer than getting the disease. Most people who get Twinrix® vaccine
do not have any problems with it.
Adverse reactions following Twinrix® vaccine are similar to what might occur after vaccination
with single-antigen hepatitis A and B vaccines, including:
 soreness where the shot was given (25-50%)
 headache (about 16%))
 tiredness (about 7%)
 mild to moderate fever (about 1%)
If these problems occur, they usually last for 1 or 2 days.
The frequency of adverse reactions did not increase with subsequent doses of Twinrix. No
serious vaccine-related adverse reactions were observed.
WARNING: WHO SHOULD NOT RECEIVE THE VACCINE:
 People with known hypersensitivity to any component of the vaccine.
 Vaccine should be delayed in patients with a moderate to severe febrile illness or active
infection until after the illness resolves NOTE: Minor illnesses such as mild upper
respiratory infections, with or without low-grade fever, are not reasons to delay the vaccine.
QUESTIONS:
If you have any questions about hepatitis A or B disease or Twinrix vaccine, please ask us now
or call your doctor before you receive the vaccine.
Twinrix Important Information Statement
rev. 10/6/11