HepaGam B NovaPlus

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.

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.

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

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.

Applies to hepatitis b immune globulin: solution

Along with its needed effects, hepatitis b immune globulin (the active ingredient contained in HepaGam B NovaPlus) 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 while taking hepatitis b immune globulin:

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

• 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 of hepatitis b immune globulin 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:

• Back pain
• general feeling of discomfort
• headache
• muscle aches or pain
• nausea
• pain at the injection site

• Abdominal or stomach cramping
• burning, heat, and redness at the injection site
• diarrhea
• feeling as if you are going to vomit
• joint pain

• 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