Other drug names:	A-Am  An-Az  B  C-Ch  Ci-Cz  D-Dh  Di-Dz  E  F  G  H  I-J  K-L  M-Mh  Mi-Mz  N-Nh  Ni-Nz  O  P-Pl  Pm-Pz  Q-R  S-Sn  So-Sz  T-To  Tp-Tz  U-V  W-Z  0-9

In the U.S.—

Twinrix

• Immunizing agent, active

Hepatitis (hep-ah-TY-tiss) A virus vaccine inactivated and hepatitis B virus vaccine recombinant is used to prevent infection caused by Hepatitis A and Hepatitis B in patients 18 years of age or older. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. Hepatitis A and Hepatitis B are highly contagious, serious diseases of the liver.

The hepatitis A virus (HAV) is spread most often through infected food or water. Hepatitis A may also be spread by close person-to-person contact with infected persons (such as between persons living in the same household). Although some infected persons do not appear to be sick, they are still able to spread the virus to others.

Hepatitis A is less common in the U.S. and other areas of the world that have a higher level of sanitation and good water and sewage (waste) systems. However, it is a significant health problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote (out-of-the-way) areas, hepatitis A vaccine will help protect you from hepatitis A disease.

Hepatitis B (HBV) is spread by contact with body fluids, such as blood, saliva, semen, or vaginal fluids; by needle sticks or sharing needles; or from mother to child.

Hepatitis A and Hepatitis B combination vaccine is recommended for all persons 18 years of age or older who are at risk from infection from their jobs or some behaviors, or from traveling to the following parts of the world:

• Africa.
• the Caribbean.
• Central and South America.
• Eastern and southern Europe.
• the Middle East.
• South and southeast Asia (except Japan).
• the Soviet Union (former).

Hepatitis A and Hepatitis B combination vaccine is also recommended for:

• Military personnel.
• Persons living in or moving to areas that have a high rate of HAV infection and who are at a high risk of HBV infection.
• Persons engaging in high-risk sexual activity, such as homosexual and bisexual males.
• Persons who use illegal injectable drugs.
• Persons at risk through their work, such as laboratory workers who handle live hepatitis A and hepatitis B virus, police and those who give first aid or medical help, and workers who come in contact with stool or sewage.
• People who work in child day-care centers and correctional facilities, residents of drug and alcohol treatment centers, and patients and staff in hemodialysis units.
• Patients who frequently receive blood and blood products, including those people who have problems with clotting, such as hemophiliacs.
• Persons with chronic liver disease.
• Healthcare workers who give first aid or emergency medical care.
• People who are at increased risk for HBV infection and who are in close contact with patients that have hepatitis A or B.

This medicine is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hepatitis A and hepatitis B combination vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any hepatitis A or hepatitis B vaccine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding— It is not known whether hepatitis A and hepatitis B combination vaccine passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who receive this vaccine and who wish to breast-feed should discuss this with their doctor.

Children— Studies on this vaccine have been done only in adult patients, and there is no specific information comparing use of hepatitis A and hepatitis B combination vaccine in children with use in other age groups.

Older adults— Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hepatitis A and hepatitis B combination vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines— Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving hepatitis A and hepatitis B combination vaccine, it is especially important that your health care professional know if you are taking the following:

• Anticoagulants (blood thinners)—Because hepatitis A and hepatitis B combination vaccine must be injected into a muscle, it may cause bleeding

Other medical problems—The presence of other medical problems may affect the use of hepatitis A and hepatitis B combination vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to yeast—Hepatitis A and hepatitis B combination vaccine is made with yeast

• Bleeding problems or
• Low blood platelet count—Because hepatitis A and hepatitis B combination vaccine must be injected into a muscle, it may cause bleeding

• Hepatitis A or
• Hepatitis B—The vaccine will not work in patients who already have the disease

• Illness, moderate or severe, with or without fever—The vaccine should not be given until after the illness has cleared up

• Immune system problems—The vaccine may not work properly in patients with this condition

Dosing—

The dose of hepatitis A and hepatitis B combination vaccine will be different for different patients. Follow your doctor's orders. The following information includes only the average doses of hepatitis A and hepatitis B combination vaccine.

• For injection dosage form:
  • For prevention of hepatitis A and hepatitis B:
    • Adults—One milliliter (mL) injected into the arm muscle during the first office visit, then at one month and six months after the first dose, for a total of three doses.
    • Children—Use and dose must be determined by your doctor.

Side Effects of This Vaccine

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

• Symptoms of allergic reaction--Rare
  • Difficulty in breathing or swallowing;  hives;  itching, especially of feet or hands;  reddening of skin, especially around ears;  swelling of eyes, face, or inside of nose;  unusual tiredness or weakness (sudden and severe) 
  
  

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Soreness at the place of injection 
  
  

• Less common
  • Cough;  fever;  hardening or thickening of skin at the place of injection;  sneezing;  sore throat 
  
  

• Rare
  • Abdominal or stomach pain;  back pain ;  bruising at the place of injection;  difficulty in moving;  dizziness;  fainting or lightheadedness when getting up from a lying or sitting position;  feeling of constant movement of self or surroundings;  feeling of warmth;  headache, may be severe;  irritability and agitation ;  itching, redness, or swelling at the place of injection ;  large, flat, blue or purplish patches in the skin at the place of injection;  loss of appetite;  muscle pain;  nausea;  pain, swelling, or redness in joints;  palpitations ;  rash;  runny nose;  sensation of spinning;  sleepiness;  sleeplessness;  small, red or purple spots on skin;  sweating;  tingling, burning, or prickly sensations;  trouble sleeping;  unusual drowsiness;  unusually fast heartbeat;  unusually warm skin;  vomiting;  weakness;  weight loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 07/25/2001

Revised: 8/22/2001