In the U.S.—

• Immunizing agent (passive)

Hepatitis B Immune Globulin (Human) ( hep-ah-TY-tiss B im-yoon GLOB-u-lin) is used to prevent hepatitis B.

Hepatitis B Immune Globulin (Human) may be used for the following patients:

• Sexual partners of persons with hepatitis B.
• 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.
• Those who have household exposure to persons with acute hepatitis B and babies less than 12 months old whose caregiver tests positive for hepatitis B.
• Babies born to mothers who test positive for hepatitis B.

This medicine is available only from your doctor or other authorized health care professional, 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 B immune globulin (human), the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to hepatitis B or any other human immune globulin . 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 B immune globulin (human) passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of hepatitis B immune globulin (human) in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of hepatitis B immune globulin in the elderly with use in other age groups.

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 taking hepatitis B immune globulin (human), it is especially important that your health care professional know if you are taking any of the following:

• Vaccines made from a live virus (except the oral poliovirus vaccine or yellow fever vaccine)—Hepatitis B immune globulin (human) may interfere with how well the vaccine will work

• Bleeding problems— Because hepatitis B immune globulin (human) is given as a shot into a muscle, it may cause more bleeding

• Immune system problems—Hepatitis B immune globulin (human) may cause severe allergic reactions

Hepatitis B immune globulin (human) is given as a shot into the muscle of the upper arm, upper thigh, or outer area of the buttocks.

Dosing—

The dose of hepatitis B immune globulin (human) will be different for different patients. The following information includes only the average doses of hepatitis B immune globulin.

• For injectable dosage form:
  • For prevention of hepatitis B following nonsexual exposure:
    • Adults—Dose is based on weight and will be determined by your doctor. If you have never been vaccinated with hepatitis B virus vaccine, your doctor may start the vaccination series. If you have been vaccinated, you may need a booster.
    • Infants with mothers who test positive for hepatitis B—Dose is usually 0.5 milliliters (mL) injected into a muscle in the thigh.
  • For prevention of hepatitis B following sexual exposure:
    • Adults—Dose is based on weight and will be determined by your doctor. Your doctor may start the hepatitis B virus vaccination series if the exposure has been within the last 14 days or if sexual contact is likely to continue.
  • For prevention of hepatitis B following household exposure:
    • Infants less than 12 months of age—Dose is usually 0.5 mL injected into a muscle in the thigh.

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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Back pain;  general feeling of discomfort ;  headache;  muscle aches or pain;  nausea;  pain at the injection site 
  
  

• Less common
  • Abdominal or stomach cramping;  burning, heat, and redness at the injection site;  chills;  diarrhea;  feeling as if you are going to vomit;  joint pain;  lightheadedness ;  skin rash;  unusual tiredness or weakness 
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, hepatitis B immune globulin (human) is used to prevent infection by the hepatitis B virus in patients who have had liver transplants.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.