Pronunciation:

hep-ah-TY-tiss B vak-seen re-KOM-bin-ant

Brand Names:

• Engerix-B
• Engerix-B Pediatric
• Recombivax HB
• Recombivax HB Pediatric/Adolescent

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Hepatitis 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.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this 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 Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 Medicine:

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

Check with your doctor 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)

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Aches or pain in joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)

blurred vision or other vision changes

muscle weakness or numbness or tingling of arms and legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Soreness at the place of injection

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 pain or 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.