hepatitis B immune globulin

Generic Name: hepatitis B immune globulin (HEP a TYE tis B im MYOON GLOB yoo lin)
Brand Name: HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB, H-BIG, Hyperhep, Bayhep B, Nabi-HB Novaplus

What is hepatitis B immune globulin?

Hepatitis B immune globulin is made from human plasma containing proteins that protect against the type B form of hepatitis (inflammation of the liver).

Hepatitis B immune globulin is used to prevent hepatitis B in people receiving a liver transplant, and in babies born to mothers infected with hepatitis B. It is also used to prevent hepatitis B in people who have been exposed to hepatitis B through contaminated blood products, sexual contact with an infected person, or living in a home with an infected person.

Hepatitis B immune globulin is not a vaccine. Therefore it will not provide long-term protection from hepatitis B. For long-term protection you must receive a hepatitis B vaccine such as Engerix-B, Recombivax HB, or Twinrix.

Hepatitis B immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hepatitis B immune globulin?

Hepatitis B immune globulin may increase your risk of blood clots, especially if you have heart disease or a history of blood clots, or if you need to use a blood thinner, if you are an older adult, if you are bedridden, if you take birth control pills or hormone replacement, or if you use certain types of catheters.

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Call your doctor at once if you have: sudden numbness or weakness (especially on one side of the body); chest pain, trouble breathing, rapid heart rate, coughing up blood; or if you have pain, swelling, warmth, or redness in your arms or legs.

What should I discuss with my health care provider before receiving hepatitis B immune globulin?

You should not receive hepatitis B immune globulin if you are allergic to it.

Hepatitis B immune globulin may increase your risk of blood clots, especially if you have:

  • heart disease, coronary artery disease (hardened arteries), history of blood clots;

  • risk factors for coronary artery disease (such as menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being an older adult);

  • if you need to use a blood thinner;

  • if you take birth control pills or hormone replacement;

  • if you use certain types of catheters; or

  • if you are bedridden or otherwise debilitated.

To make sure hepatitis B immune globulin is safe for you, tell your doctor if you have:

  • an allergy to human immune globulins;

  • bleeding or blood clotting disorder such as hemophilia; or

  • diabetes.

Hepatitis B immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether hepatitis B immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hepatitis B immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is hepatitis B immune globulin given?

Hepatitis B immune globulin is injected into a muscle or into a vein through an infusion pump. A healthcare professional will give you this injection.

For prevention after exposure to contaminated blood: Hepatitis B immune globulin is usually given as soon as possible after exposure to an infected person, preferably within 7 days. A booster medication is then given 24 hours later. Your doctor may also recommend that you receive a hepatitis B vaccine when you start treatment with hepatitis B immune globulin.

For liver transplant: Hepatitis B immune globulin is given as part of the transplant procedure, and then for several weeks or months afterward. The medication is usually given to transplant patients every day for 7 days, then every 2 weeks for the next 11 weeks, followed by monthly injections from then on.

For prevention after sexual contact with an infected person: Hepatitis B immune globulin is given as a single dose within 14 days after the last contact. You should also receive a hepatitis B vaccine if you will continue to have contact with the infected person.

For prevention in people sharing the home of an infected person: This medicine should be given to infants younger than 12 months old, caregivers who may come into contact with the infected person's blood, and people who share razors, toothbrushes, or other personal items with the infected person. Household members may also need to receive hepatitis B vaccine.

For babies born to mothers infected with hepatitis B: This medicine is usually given within 12 hours after birth, or when the baby is medically stable.

In addition to hepatitis B immune globulin, the baby should also receive hepatitis B vaccine, which is given in a series of 3 shots.

  • The first hepatitis B vaccine is usually given when the child is 7 days old. The booster shots are then given 1 month and 6 months after the first hepatitis B vaccine.

  • If the baby does not receive the first hepatitis B vaccine before the age of 3 months, a second dose of hepatitis B immune globulin must be given.

  • Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

  • If the baby does not receive hepatitis B vaccine at all, a second and third dose of hepatitis B immune globulin must be given 3 and 6 months after the first dose. Follow your doctor's instructions.

While using hepatitis B immune globulin, you may need frequent blood tests.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using hepatitis B immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your hepatitis B immune globulin injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving hepatitis B immune globulin?

Do not receive a "live" vaccine while using hepatitis B immune globulin, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You can safely receive a hepatitis B vaccine during your treatment with hepatitis B immune globulin.

Hepatitis B immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, mouth sores, red or swollen gums;

  • a light-headed feeling, like you might pass out;

  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • symptoms of fluid buildup around your lungs--chest pain, pain when you breathe, rapid heart rate, feeling light-headed or short of breath (especially when lying down); or

  • symptoms of a blood clot or stroke--sudden numbness or weakness (especially on one side of the body); chest pain, trouble breathing, rapid heart rate, coughing up blood; or pain, swelling, warmth, or redness in your arms or legs.

Common side effects may include:

  • nausea, vomiting, diarrhea, upset stomach;

  • back pain, tired feeling;

  • tremors, memory problems, agitation, vision problems;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • mild rash; or

  • pain, redness, bruising, or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Hepatitis B immune globulin dosing information

Usual Adult Dose for Exposure to Hepatitis B Virus:

Prevention of recurrence following liver transplantation:
HBIG 20,000 intl units IV once with the grafting of the transplanted liver (the anhepatic phase)
Week 1 postoperative: 20,000 intl units IV daily from day 1 to 7
Week 2 to 12 postoperative: 20,000 intl units IV every two weeks from day 14
Month 4 onwards: 20,000 intl units IV monthly

If patients fail to reach anti-HBs levels of 500 intl units/L within the first week post-liver transplantation, dosage adjustments may be required.

Dosage regimen should be increased to 10,000 intl units IV every 6 hours until the target anti-HBs are reached in patients who are especially susceptible to extensive loss of circulated anti-HBs, such as those who have surgical bleeding or abdominal fluid drainage (greater than 500 mL) or patients who undergo plasmapheresis.

Percutaneous or permucosal blood exposure:
Source is HBsAg-positive and exposed person has been vaccinated:
If exposed person's anti-HBs level is less than 10 sample ratio units (10 million intl units) by RIA or negative by EIA:
Hepatitis B immune globulin (HBIG) 0.06 mL/kg IM once plus
hepatitis B vaccine booster dose or second dose of hepatitis B immune globulin 1 month later.

Source is HBsAg-positive and exposed person is unvaccinated:
HBIG 0.06 mL/kg IM once plus start hepatitis B vaccine series.

Source is high risk for HBsAg-positive and exposed person has been vaccinated:
Previously vaccinated exposed person:
If vaccine nonresponder and source is HBsAg-positive, give HBIG 0.06 mL/kg IM once plus hepatitis B vaccine booster dose or second dose of hepatitis B immune globulin 1 month later.
If exposed person does not respond to at least 4 doses of vaccine, give 2 doses of HBIG.

Source is high risk for HBsAg-positive and exposed person is unvaccinated:
Start hepatitis B vaccine series within 7 days of exposure
plus HBIG 0.06 mL/kg IM once if source tests positive for HBsAg.

Source unknown or low risk for HBsAg-positive and exposed person is vaccinated:
No treatment required.

Source unknown or low risk for HBsAg-positive and exposed person is unvaccinated:
Start hepatitis B vaccine series within 7 days of exposure.

Sexual exposure to HBsAg-positive source:
HBIG 0.06 mL/kg IM once
plus start hepatitis B vaccine series within 14 days of last contact or if contact will continue.

Usual Pediatric Dose for Exposure to Hepatitis B Virus:

Infants born to HBsAg-positive mothers:
HBIG 0.5 mL IM at birth (preferably within 12 hours) plus start hepatitis B vaccine series.
Test infant for HBsAg and anti-HBs at 12 to 15 months.

Household exposure:
Less than 12 months: HBIG 0.5 mL plus hepatitis B vaccine if the mother or primary caregiver has an acute HBV infection.

Other exposures:
See adult recommendations

What other drugs will affect hepatitis B immune globulin?

Other drugs may interact with hepatitis B immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about hepatitis B immune globulin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-08-13, 2:21:15 PM.

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