Nabi-HB NovaPlus

Hepatitis B Immune Globulin (Human) 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 available only from your doctor or other authorized health care professional .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although this use is not included in product labeling, hepatitis B immune globulin (human) is used to prevent infection by the hepatitis B virus in patients who have had liver transplants.

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

Although there is no specific information comparing use of hepatitis B immune globulin (human) in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing use of hepatitis B immune globulin in the elderly with use in other age groups.

Pregnancy

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Bleeding problemsa€” Because hepatitis B immune globulin (human) is given as a shot into a muscle, it may cause more bleeding

• Immune system problemsa€”Hepatitis B immune globulin (human) may cause severe allergic reactions

Proper Use

Hepatitis B immune globulin (human) is given as a shot into the muscle of the upper arm, upper thigh, or outer area of the buttocks.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form:
  
  
  
  • For prevention of hepatitis B following nonsexual exposure:
    
    
    
    • Adultsa€”Dose is based on weight and will be determined by your doctor . If you have never been vaccinated with hepatitis B virus vaccine, your doctor may start the vaccination series. If you have been vaccinated, you may need a booster .
    
    
    • Infants with mothers who test positive for hepatitis Ba€”Dose is usually 0.5 milliliters (mL) injected into a muscle in the thigh.
    
    
    
    
  
  
  • For prevention of hepatitis B following sexual exposure:
    
    
    
    • Adultsa€”Dose is based on weight and will be determined by your doctor . Your doctor may start the hepatitis B virus vaccination series if the exposure has been within the last 14 days or if sexual contact is likely to continue.
    
    
    
    
  
  
  • For prevention of hepatitis B following household exposure:
    
    
    
    • Infants less than 12 months of agea€”Dose is usually 0.5 mL injected into a muscle in the thigh.
    
    
    
    
  
  
  
  

Side Effects

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


• Chills


• Diarrhea


• Feeling as if you are going to vomit


• Joint pain


• Lightheadedness


• Skin rash


• Unusual tiredness or weakness

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.