Nabi-HB NovaPlus (Intramuscular, Intravenous)

Hepatitis B immune globulin (Human) injection is used to prevent hepatitis B from happening again in liver transplant patients who are HBsAg-positive. This medicine also helps protect you from getting sick if you have been exposed to the hepatitis B virus.

Hepatitis B immune globulin (Human) injection may be used for the following patients:

• Sexual partners of people with hepatitis B.
• People who may be exposed to the virus through 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 people 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 should only be given by or under the supervision of your doctor.

It is very important for your doctor to 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 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 regularly 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 due to 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 happen if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you must stay in bed for a long time due to 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).

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies on the effects of hepatitis B immune globulin injection in children. However, safety and effectiveness have been confirmed in children receiving similar medicines to prevent hepatitis B infection after exposure to hepatitis B virus.

Geriatric

Studies so far have not shown any specific issues for older adults that would limit the use of hepatitis B immune globulin injection. However, older patients are more likely to have age-related kidney, liver, or heart problems, which may require careful monitoring and possible dose adjustments for those receiving hepatitis B immune globulin injection.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together with caution. In cases where an interaction might happen, your doctor may need to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the following medicines while receiving this medicine. The following interactions have been highlighted for their potential significance but may not include all possible interactions.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Adenovirus Vaccine
• 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 Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain types of food because interactions may occur. Drinking alcohol or using tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Severe allergy to human globulin, history of
• Immunoglobulin (IgA) deficiency—Should not be given to patients with these conditions.

• History of atherosclerosis (hardening of the arteries)
• History of blood clotting problems
• Diabetes
• Heart or blood vessel disease
• Known or suspected hyperviscosity (thick blood)
• Prolonged periods of immobilization—Use with caution. May worsen side effects.

• Severe blood clotting problems
• Severe thrombocytopenia (low number of platelets)—Should not be given to patients receiving this medicine for postexposure prophylaxis unless the benefits outweigh the risks.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they might require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

Rare

• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when getting up suddenly from lying down or sitting
• Sweating
• Unusual tiredness or weakness

Incidence not known

• Chills
• Cough
• Difficulty or labored breathing
• Trouble 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 require medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist, become 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 like 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Serum

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.