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NABI-HB

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Overview

What is NABI-HB?

DESCRIPTION Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of immunoglobulin (5 1 percent protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 Oncley 9 cold-alcohol fractionation process1, 2 with two added viral reduction steps described below. Nabi-HB is formulated in 0.042-0.108 M sodium chloride, 0.10-0.20 M glycine, and 0.005-0.050 percent polysorbate 80, at pH 5.8-6.5. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only. Each plasma donation used for the manufacture of Nabi-HB is tested for the presence of hepatitis B virus (HBV) surface antigen (HBsAg), human immunodeficiency viruses (HIV) 1/2, and hepatitis C virus (HCV) antibodies. In addition, pooled samples of Source Plasma used in the manufacture of this product are tested by FDA licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. Investigational NAT for hepatitis A virus (HAV) and HBV is also performed on pooled samples of all Source Plasma used, and found to be negative; however, the significance of a negative result has not been established. Investigational NAT for parvovirus B19 (B19) is also performed on pooled samples of all Source Plasma and the limit for B19 DNA in a manufacturing pool is set not to exceed 104 IU/mL. The manufacturing steps for Nabi-HB are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) 3. Virus filtration, using a Planova 35 nm Virus Filter, is effective in reducing some known enveloped and non-enveloped viruses4. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in the following table



What does NABI-HB look like?



What are the available doses of NABI-HB?

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What should I talk to my health care provider before I take NABI-HB?

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How should I use NABI-HB?

DOSAGE AND ADMINISTRATION This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi- HB, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately. Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine11. Acute Exposure to Blood Containing HBsAg Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear12. An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine. For persons who refuse hepatitis B vaccine or are known non-responders to vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given one month after the first dose12. Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM. See manufacturers' recommendation for appropriate dose. Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay. Two doses of Hepatitis B Immune Globulin (Human) is preferred if no response after at least four doses of vaccine. Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic stabilization of the infant and preferably within 12 hours of birth. The hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer. Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive hepatitis B vaccine within 12 hours of birth (see manufacturers' recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human) administered after 48 hours of age is not known10,19. Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected12. See manufacturers' recommendations for appropriate dose. 0.5 mL administered IM at a site different from that used for the vaccine. See ACIP recommendation. Sexual Exposure to HBsAg-positive Persons All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the hepatitis B vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human) may improve the efficacy of post exposure treatment. The vaccine has the added advantage of conferring long-lasting protection19. Household Exposure to Persons with Acute HBV Infection Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine19.


What interacts with NABI-HB?

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What are the warnings of NABI-HB?

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What are the precautions of NABI-HB?

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What are the side effects of NABI-HB?

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What should I look out for while using NABI-HB?

CONTRAINDICATIONS Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB contains not more than 40 micrograms per mL IgA. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions. The physician must weigh the potential benefit of treatment with Nabi-HB against the potential for hypersensitivity reactions.

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What might happen if I take too much NABI-HB?

OVERDOSAGE Although no data are available, clinical experience reported with other human immune globulins suggests that the only manifestations of overdose with Nabi-HB, Hepatitis B Immune Globulin (Human), would be pain and tenderness at the injection site.


How should I store and handle NABI-HB?

Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.HOW SUPPLIED Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:NDC Number Contents 59730-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert59730-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert HOW SUPPLIED Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:NDC Number Contents 59730-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert59730-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert HOW SUPPLIED Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:NDC Number Contents 59730-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert59730-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert