Description
Hepatitis B immune globulin (Human) injection is used to prevent hepatitis B from occurring again in HBsAg-positive liver transplant patients who have had liver transplants. This medicine also helps keep you from getting sick if you have been exposed to hepatitis B virus.
Hepatitis B immune globulin (Human) injection 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 to be administered only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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 this medicine, 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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of hepatitis B immune globulin injection in the pediatric population. However, safety and efficacy have been established in children who are receiving similar medicines for prevention of hepatitis B infection after exposure to hepatitis B virus.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis B immune globulin injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving hepatitis B immune globulin injection.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Dengue Tetravalent Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy (severe) to human globulin, history of or
- Immunoglobulin (IgA) deficiency—Should not be given to patients with these conditions.
- Atherosclerosis (hardening of the arteries), history of or
- Blood clotting problems, history of or
- Diabetes or
- Heart or blood vessel disease or
- Hyperviscosity (thick blood), known or suspected or
- Prolonged periods of immobilization—Use with caution. May cause side effects to become worse.
- Blood clotting problems or
- Thrombocytopenia (low number of platelets), severe—Should not be given to patients who are receiving this medicine for postexposure prophylaxis unless the benefits outweigh the risks.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a muscle or a vein.
If you are using this medicine for prevention of hepatitis B from occurring again in patients who have had liver transplants, this medicine is given through a needle placed in one of your veins.
If you are using this medicine for prevention of hepatitis B infection after being exposed to hepatitis B virus, it should be given as a shot into one of your muscles.
This medicine works best if you receive it soon after being exposed to hepatitis B. If you had sexual contact with a person who has hepatitis B, you should receive this medicine within 14 days. If you were exposed some other way, you should receive this medicine within 24 hours of being exposed to hepatitis B.
You may need to have a second dose of medicine 1 month after the first dose. Make sure you understand the schedule if you need to have a second dose.
This medicine may be given to a baby if the baby's mother has hepatitis B. The baby is often given the medicine within 12 hours after birth. Ask your doctor about the schedule if your baby needs this medicine.
Hepatitis B vaccine is often used in addition to hepatitis B immune globulin. Make sure you understand if you also need the vaccine.
Precautions
It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.
Hepatitis B immune globulin injection may cause serious allergic reactions. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after receiving the medicine.
If you are also using insulin or other medicine for diabetes, you will need to be aware of the symptoms of hypoglycemia (confusion, irritability, double or blurred vision, and in severe cases seizures or loss of consciousness) because this medicine may affect the results of blood sugar tests. Let your doctor know if you experience hypoglycemia on a regular basis while receiving this medicine.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.
This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.
Talk to your doctor before getting flu shots or other vaccines while receiving or after receiving hepatitis B immune globulin. Some vaccines may not work as well while you are using this medicine.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (e.g., serological tests).
Side Effects
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 or nurse immediately if any of the following side effects occur:
Rare
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sweating
- unusual tiredness or weakness
Incidence not known
- Chills
- cough
- difficult or labored breathing
- difficulty with swallowing
- dizziness
- fast heartbeat
- fever
- hives
- itching
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shortness of breath
- skin rash
- tightness in the chest
- wheezing
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
- 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
- diarrhea
- feeling as if you are going to vomit
- joint pain
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- cold sweats
- feeling cold
- flu-like symptoms
- upper abdominal or stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
