Uses

This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.

How To Use

If this medication is given for prevention of hepatitis B after direct exposure to the virus, it is given by injection into a muscle by a healthcare professional. It is best to receive this medication as soon as possible after exposure. If you wait too long after being exposed, the medication may not be effective. Your doctor may also recommend vaccination after receiving this medication. Talk with your doctor about the best treatment for you.

If this medication is given after a liver transplant to prevent return of hepatitis B infection, it is given by injection into a vein by a healthcare professional. For this use, it should be given on a regular schedule. To help you remember, mark your calendar with an appointment reminder.

The dosage and schedule of injections is based on your medical condition, weight, and response to treatment.

Side Effects

See also Warning section.

Redness, pain, or tenderness at the injection site may occur. Nausea, vomiting, fever, chills, dizziness, headache, or back/joint pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood clotting problems
• a certain immune system problem (immunoglobulin A deficiency)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections (such as hepatitis A) from the medication. Consult your doctor or pharmacist for more information.

Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your doctor or pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain tests (including certain blood sugar tests, Coomb's test), possibly causing false test results. The blood sugar interference can lead to serious (possibly fatal) consequences. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, and which type of blood sugar testing strips you use.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

If you are receiving this medication on a regular schedule, laboratory and/or medical tests (such as levels of antibody in the blood) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or doctor's office and will not be stored at home.