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

HepaGam B NovaPlus 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.

HepaGam B NovaPlus 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.

HepaGam B NovaPlus may also be used for purposes not listed in this medication guide.

HepaGam B NovaPlus 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.

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.

HepaGam B NovaPlus 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: HepaGam B NovaPlus 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 this medicine.

For liver transplant: HepaGam B NovaPlus 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: HepaGam B NovaPlus 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: HepaGam B NovaPlus 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 HepaGam B NovaPlus, 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 HepaGam B NovaPlus 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 HepaGam B NovaPlus must be given 3 and 6 months after the first dose. Follow your doctor's instructions.

While using HepaGam B NovaPlus, 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 HepaGam B NovaPlus.

You should not receive HepaGam B NovaPlus if you are allergic to it.

HepaGam B NovaPlus 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 HepaGam B NovaPlus 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.

HepaGam B NovaPlus 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 HepaGam B NovaPlus 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.

Call your doctor for instructions if you miss an appointment for your HepaGam B NovaPlus.

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

Do not receive a "live" vaccine while using HepaGam B NovaPlus, 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 HepaGam B NovaPlus.

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.

HepaGam B NovaPlus may cause serious side effects. 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 of HepaGam B NovaPlus 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.

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.