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|Recombivax HB Dialysis Formulation

HEPATITIS B VACCINE RECOMBINANT (Systemic)

Some commonly used brand names are:

In the U.S.—

• Engerix-B
• Recombivax HB
• Recombivax HB Dialysis Formulation

In Canada—

• Engerix-B
• Recombivax HB
• Recombivax HB Dialysis Formulation

Another commonly used name is HB vaccine .

Category

• Immunizing agent, active

Description

Hepatitis (hep-ah-TY-tiss) B vaccine recombinant is used to prevent infection by the hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Hepatitis B vaccine recombinant is made without any human blood or blood products or any other substances of human origin and cannot give you the hepatitis B virus (HBV) or the human immunodeficiency virus (HIV).

HBV infection is a major cause of serious liver diseases, such as virus hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, children, and adolescents up to 19 years old. It is also recommended for adults who live in areas that have a high rate of hepatitis B disease or who may be at increased risk of infection from hepatitis B virus. These adults include:

• Sexually active homosexual and bisexual males, including those with HIV infection.
• Sexually active heterosexual persons with multiple partners.
• Persons who may be exposed to the virus by means of blood, blood products, or human bites, such as health care workers, employees in medical facilities, patients and staff of live-in facilities and day-care programs for the developmentally disabled, morticians and embalmers, police and fire department personnel, and military personnel.
• Persons who have kidney disease or who undergo blood dialysis for kidney disease.
• Persons with blood clotting disorders who receive transfusions of clotting-factor concentrates.
• Household and sexual contacts of HBV carriers.
• Persons in areas with high risk of HBV infection [in the population], such as Alaskan Eskimos, Pacific Islanders, Haitian and Indochinese immigrants, and refugees from areas that have a high rate of hepatitis B disease; persons accepting orphans or adoptees from these areas; and travelers to these areas.
• Persons who use illegal injection drugs.
• Prisoners.

This vaccine is available only from your doctor or other authorized health care professional, in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

Before Receiving This Vaccine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to this vaccine or to the hepatitis B vaccine made from human plasma. Also tell your health care professional if you are allergic to any other substances, such as foods (especially yeast). The vaccine is made by using yeast; persons allergic to yeast may also be allergic to the vaccine.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. However, the vaccine is not expected to cause problems during pregnancy.

Breast-feeding—It is not known whether hepatitis B vaccine passes into the breast milk. However, the vaccine is not expected to cause problems in nursing babies.

Children—Hepatitis B vaccine has been tested in newborns, infants, and children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. The vaccine strength for use in dialysis patients has been studied only in adult patients, and there is no specific information about its use in children receiving dialysis.

Hepatitis B vaccine is very effective when administered to adolescents and young adults. It is recommended that all adolescents who have not previously received three doses of hepatitis B vaccine should start or complete the vaccine series at 11 to 12 years of age. Hepatitis B vaccine has not been shown to cause different side effects or problems in adolescents and young adults than it does in other age groups.

Older adults—This vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. However, persons over 50 years of age may not become as immune to the virus as do 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. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Allergic reaction to hepatitis B vaccine, history of—Use of hepatitis B vaccine is not recommended

Proper Use of This Vaccine

Dosing—The dose of hepatitis B vaccine will be different for different patients. Follow your doctor"s orders . The following information includes only the average doses of hepatitis B vaccine.

• For injection dosage form:
  • For prevention of hepatitis B infection:
    • Adults, adolescents, and older children—2.5 to 20 micrograms (mcg) injected into the arm muscle during the first office visit, then one month and six months after the first dose, for a total of three doses.
    • Adults who also receive or will receive blood dialysis—40 mcg injected into the arm muscle during the first office visit, then one month and six months after the first dose, for a total of three doses; or 40 mcg injected into the arm muscle during the first office visit, then one month, two months, and six months after the first dose, for a total of four doses.
    • Infants and young children—2.5 to 20 mcg injected into the thigh muscle during the first office visit, then one month and six months after the first dose, for a total of three doses.
    • Newborn babies—2.5 to 20 mcg injected into the thigh muscle at birth or within seven days of birth, then one month and six months after the first dose, for a total of three doses; or 10 or 20 mcg injected into the thigh muscle at birth or within seven days of birth, then one month, two months, and twelve months after the first dose, for a total of four doses.

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.

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:

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

Revised: 06/20/1997

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