Hepatitis B Immune Globulin (Intramuscular, Intravenous)

Hepatitis B immune globulin is given to prevent hepatitis B in patients who have been exposed to the virus.

Overview

Hepatitis B immune globulin is used to prevent hepatitis B in people who have been exposed to the virus, or to patients who are HBsAG-positive and have had a liver transplant to prevent hepatitis B from occurring again. It is not strictly a vaccine, but it contains proteins which protect the liver against hepatitis B for short periods of time. For long-term protection against the illness, patients must receive a hepatitis B vaccine.

The most common people who are given hepatitis B immune globulin are those who may be exposed to the hepatitis B virus via blood or blood products, such as healthcare workers, people who work in medical facilities, those who work in care facilities, morticians and embalmers, police and fire department workers, and people in the military. It may also be given to babies born to mothers with the hepatitis B virus or to infants whose caregiver has the virus, and the sexual partners of those with the virus.

Hepatitis B immune globulin is only available with a doctor's prescription and must be administered under the supervision of a doctor in a hospital or clinical environment. It is injected either into the muscle, or directly into the blood stream via a vein. In the US, its brand names include:

  • Bayhep B
  • HepaGam B
  • HyperHEP B
  • Nabi-HB

Conditions Treated?

  • Hepatitis B prevention

Type Of Medicine?

  • Human immunoglobin

Side Effects

As well as its needed effects hepatitis B immune globulin can cause a variety of unwanted effects. While not all of these are serious, some are and should be reported to a doctor immediately. You will be given Hepatitis B immune globulin in a hospital environment under your doctor's supervision, so if you notice any severe side effects, you should tell your doctor or nurse right away.

The following side effects are rare, but serious:

  • Confusion
  • Unusual tiredness or weakness
  • Blurred vision
  • Dizziness
  • Faintness, dizziness, or lightheadedness when arising
  • Sweating
  • Fever
  • Chills
  • Cough
  • Wheezing
  • Tightness in the chest
  • Labored or difficult breathing
  • Shortness of breath
  • Fast heartbeat
  • Skin rash
  • Hives
  • Itching
  • Puffiness or swelling of eyelids, face, lips or tongue

The following side effects are usually minor and do not require medical attention unless they become very prolonged or severe. If you have questions about them, speak to your doctor or nurse.

  • More common:

O Back pain

O Muscle aches or pain

O Pain at injection site

O Headache

O Nausea

O General feeling of discomfort

  • Less common:

O Joint pain

O Abdominal or stomach cramping

O Diarrhea

O Feeling as though you are going to vomit

O Burning, heat, or redness at injection site

  • Incidence unknown:

O Cold sweats

O Feeling cold

O Flu-like symptoms

O Upper abdominal or stomach pain

O Problems at injection site, such as:

  •  Bleeding
  •  Bruising
  •  Lumps
  •  Redness
  • Discoloration of the skin
  •  Blistering
  •  Ulceration
  •  Rash
  •  Hives
  •  Scarring
  •  Inflammation
  •  Burning
  •  Warmth
  •  Coldness
  •  Stinging
  •  Tingling
  •  Tenderness
  •  Numbness
  •  Pain
  •  Feeling of pressure

This may not be an exhaustive list of all side effects which could occur with hepatitis B immune globulin injections. If you notice any others not listed here, report them to your doctor or nurse right away. You could also report them to the FDA, or your doctor may do this on your behalf.

Dosage

Hepatitis B immune globulin must be given under the supervision of a doctor. Your doctor will determine an appropriate dose and they will either administer the injection themselves, or it will be given by a nurse or other healthcare professional.

The medicine can either be injected into a muscle or administered intravenously, which means it will be injected directly into a vein. Usually, patients who need the medicine to prevent the recurrence of hepatitis B following a liver transplant are given the drug intravenously. Patients who need it to prevent hepatitis B after exposure to the virus are usually given injections into the muscle.

Hepatitis B immune globulin is most effective if given as soon as possible after being exposed to the hepatitis B virus. Patients who have had sexual contact with someone who has the virus should receive the medicine within 14 days. Those who have been exposed to the virus in any other way should receive it within 24 hours.

Babies who need hepatitis B immune globulin due to their mother having hepatitis B should receive the injection within 12 hours of being born. They should also receive the hepatitis B vaccine, which is administered in a series of 3 injections. The first is usually given at 7 days old, with boosters at 1 month and 6 months after the first shot. However, if the vaccine was not initially given before the age of 3 months, a second dose of hepatitis B immune globulin may be necessary before they can have the vaccine. If doctors choose not to administer the hepatitis B vaccine, the baby may require additional shots of hepatitis B immune globulin, the second given at 3 months, and the third at 6 months.

Sometimes it is necessary to have a second dose of hepatitis B immune globulin, one month after the first. Your doctor will determine the dosing schedule with you if you need multiple injections, and it is very important that you adhere to this schedule to ensure the medicine works correctly. In some instances, doctors may also want to administer the hepatitis B vaccine in addition to hepatitis B immune globulin, so be sure to discuss this with your doctor and understand when the vaccine should be administered.

You may need frequent blood tests after being given hepatitis B immune globulin shots so that doctors can assess how successful the treatment has been and check for other complications.

Interactions

Other drugs may interact with hepatitis B immune globulin and cause an increased risk of side effects or secondary health problems. Ensure your doctor knows about all the medicines you take, including those prescribed to you, those purchased over the counter, and any herbal supplements or vitamins that you take. Where interactions do occur, doctors may change your existing medicines where possible, decide not to prescribe hepatitis B immune globulin, or they may make dosage adjustments or monitor you more closely if both drugs are deemed important.

You should not receive any'œlive vaccines within 3 months of being treated with hepatitis B immune globulin. The drug may make live vaccines less effective, which could leave you unprotected from certain diseases. Examples of live vaccines include:

  • Influenza (nasal flu)
  • Zoster (shingles)
  • Varicella (chickenpox)
  • MMR (measles, mumps, rubella)
  • Rotavirus
  • Typhoid
  • Yellow Fever

Patients can, however, receive the hepatitis B vaccine during or soon after treatment with hepatitis B immune globulin. If you have questions about vaccines and the right time to have them, consult your doctor.

Warnings

Contraindicated conditions

Make sure your doctor knows your full medical history before they administer hepatitis B immune globulin. They should know about all the conditions you currently suffer from, as well as conditions you have had in the past. It is particularly important to mention the conditions listed below, but these may not be exhaustive lists of all the conditions which could interact with hepatitis B immune globulin.

People with the following conditions should not be given hepatitis B immune globulin:

  • Severe allergy to human globulin
  • Immunoglobulin (IgA) deficiency

The following conditions may increase the risk of certain side effects associated with hepatitis B immune globulin. Doctors will use caution when prescribing the drug to patients with these conditions, and they may want to monitor the patient more closely than usual.

  • Diabetes
  • Heart or blood vessel disease
  • Atherosclerosis (hardening of the arteries)
  • Hyperviscosity (thick blood)
  • Prolonged periods of immobilization

Patients who are being given hepatitis B immune globulin for exposure to hepatitis B should not be administered the medicine if they have the following conditions, unless the benefits of the drug outweigh potential risks.

  • Blood clotting problems
  • Thrombocytopenia

Increased risk of blood clots

Hepatitis B immune globulin can increase the risk of blood clots, particularly for people who are already susceptible to blood clots due to certain conditions. Certain birth control pills or hormone replacement therapies can increase the risk of blood clots. Using certain types of catheters and being bedridden or otherwise immobilized are also risk factors. People with coronary artery disease or who are at high risk of the condition (due to being overweight, smoking, having high blood pressure or cholesterol levels, or having a family history of the condition) are also more susceptible to blood clots. Ensure your doctor knows your full medical history so that they can assess the risk of you developing blood clots after taking hepatitis B immune globulin.

Lab tests

Hepatitis B immune globulin can cause unusual results for lab tests involving glucose (sugar) in the blood. Be sure to tell any doctor you see that you have recently been administered hepatitis B immune globulin injections if they request blood tests.

Allergy

Tell your doctor if you have had an allergic reaction to human globulin in the past, or to medicines similar to hepatitis B immune globulin. You should also mention any other allergies you suffer from, including food, chemical, drug, pollen, and animal allergies, so that they can check you are not allergic to any of the ingredients in hepatitis B immune globulin.

Pregnancy and breastfeeding

There have not been adequate human or animal trials into hepatitis B immune globulin to assess what effects it may have during pregnancy, both upon the mother and the fetus. The drug is therefore in FDA category C, which means it should only be used if potential benefits to the mother far outweigh potential risks to the fetus.

It is not known whether hepatitis B immune globulin is excreted in human breast milk and, if so, what effects it could have on nursing infants. Nursing mothers should discuss potential risks with their doctor in order to decide whether to avoid hepatitis B immune globulin treatment or discontinue breastfeeding.

Storage

Since hepatitis B immune globulin is administered by a doctor, nurse, or other healthcare professional in a hospital environment, patients will not be expected to store the medicine at home.

Summary

Hepatitis B immune globulin is given to people who are at risk of developing hepatitis B. It can be prescribed to those who have been exposed to the hepatitis B virus through blood contact or sexual activity, or to newborn babies whose mothers have the virus. Usually, these patients receive the drug via an injection into the muscle. It may also be given to liver transplant patients who have the virus to protect their new liver from hepatitis B. In these instances, the drug is administered via an IV. Sometimes the hepatitis B vaccine is given in addition to hepatitis B immune globulin.

It is relatively common for patients to experience muscle aches and pain, headaches, nausea, back pain, and a general feeling of discomfort after being given hepatitis B immune globulin. These side effects do not require treatment unless they become very severe. Patients who experience dizziness, confusion, fainting, breathing problems, fever or chills, or rapid heartbeat should report these side effects to their doctor immediately.

Hepatitis B immune globulin can only be administered in a clinical setting and under the supervision of a doctor. It can increase the risk of blood clots, and patients who are already at a higher risk of blood clots may need to be monitored more closely. This includes people with coronary artery disease, blood clotting problems, hyperviscosity, and heart or blood vessel disease, as well as those who are immobilized for long periods due to disability. The drug should not be given to people with severe human globulin allergy or immunoglobin deficiency.