HEPATITISB 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
Description
Hepatitis (hep-ah-TY-tiss) B vaccine recombinantis used to prevent infection by the hepatitis B virus. The vaccine works bycausing your body to produce its own protection (antibodies) against the disease.
Hepatitis B vaccine recombinant is made without any human blood or bloodproducts or any other substances of human origin and cannot give you the hepatitisB virus (HBV) or the human immunodeficiency virus (HIV).
HBV infection is a major cause of serious liver diseases, such as virushepatitis and cirrhosis, and a type of liver cancer called primary hepatocellularcarcinoma.
Pregnant women who have hepatitis B infection or are carriers of hepatitisB virus can give the disease to their babies when they are born. These babiesoften suffer serious long-term illnesses from the disease.
Immunization against hepatitis B disease is recommended for all newbornbabies, infants, children, and adolescents up to 19 years old. It is alsorecommended for adults who live in areas that have a high rate of hepatitisB 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 withHIV infection.
- Sexually active heterosexual persons with multiple partners.
- Persons who may be exposed to the virus by means of blood, bloodproducts, or human bites, such as health care workers, employees in medicalfacilities, patients and staff of live-in facilities and day-care programsfor the developmentally disabled, morticians and embalmers, police and firedepartment personnel, and military personnel.
- Persons who have kidney disease or who undergo blood dialysis forkidney disease.
- Persons with blood clotting disorders who receive transfusions ofclotting-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; personsaccepting 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 healthcare 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 beweighed against the good it will do. This is a decision you and your doctorwill make. For hepatitis B recombinant vaccine, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to this vaccine or to the hepatitis B vaccine made fromhuman plasma. Also tell your health care professional if you are allergicto any other substances, such as foods (especially yeast). The vaccine ismade by using yeast; persons allergic to yeast may also be allergic to thevaccine.
Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. However, the vaccine is not expected to causeproblems during pregnancy.
Breast-feeding?It is not known whether hepatitis B vaccine passesinto the breast milk. However, the vaccine is not expected to cause problemsin nursing babies.
Children?Hepatitis B vaccine has been tested in newborns,infants, and children and, in effective doses, has not been shown to causedifferent side effects or problems than it does in adults. The vaccine strengthfor use in dialysis patients has been studied only in adult patients, andthere is no specific information about its use in children receiving dialysis.
Hepatitis B vaccine is very effective when administered to adolescentsand young adults. It is recommended that all adolescents who have not previouslyreceived three doses of hepatitis B vaccine should start or complete the vaccineseries at 11 to 12 years of age. Hepatitis B vaccine has not been shown tocause different side effects or problems in adolescents and young adults thanit does in other age groups.
Older adults?This vaccine is not expected to causedifferent side effects or problems in older people than it does in youngeradults. However, persons over 50 years of age may not become as immune tothe virus as do younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of hepatitis B vaccine. Make sure you tell yourdoctor if you have any other medical problems, especially:
- Allergic reaction to hepatitis B vaccine, history of?Use ofhepatitis B vaccine is not recommended
Proper Use of This Vaccine
Dosing?The dose of hepatitis B vaccine will be differentfor 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 onemonth and six months after the first dose, for a total of three doses.
- Adults who also receive or will receive blood dialysis?40 mcginjected into the arm muscle during the first office visit, then one monthand six months after the first dose, for a total of three doses; or 40 mcginjected 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 thethigh muscle during the first office visit, then one month and six monthsafter the first dose, for a total of three doses.
- Newborn babies?2.5 to 20 mcg injected into the thigh muscleat birth or within seven days of birth, then one month and six months afterthe first dose, for a total of three doses; or 10 or 20 mcg injected intothe thigh muscle at birth or within seven days of birth, then one month, twomonths, 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 maycause 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
Difficultyin breathing or swallowing; hives; itching, especially of feet or hands; reddening ofskin, especially around ears; swelling of eyes, face,or inside of nose; unusual tiredness or weakness(sudden and severe)
Other side effects may occurthat usually do not need medical attention. However, check with your doctorif any of the following side effects continue or are bothersome:
Less common
Dizziness; fever of 37.7 ?C (100?F) or higher; hard lump, redness, swelling,pain, itching, purple spot, tenderness, or warmth at place of injection; headache; unusual tiredness or weakness
Rare
Aches or pain in muscles; back painor stiffness or pain in neck or shoulder; chills; diarrhea or stomach cramps or pain; general feeling of discomfort or illness; increased sweating; headache (mild), sore throat,runny nose, or fever (mild); itching; lack of appetite or decreased appetite; nausea or vomiting; sudden redness of skin; swelling of glands in armpit or neck; trouble in sleeping; welts
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Revised: 06/20/1997
