Nabi-hb
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Side Effects & Adverse Reactions
WARNINGS In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks. Nabi-HB is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses. The Nabi-HB manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB is filtered using a Planova 35 nm Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Biotest Pharmaceuticals at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
INDICATIONS AND USAGE Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings: Acute Exposure to Blood Containing HBsAg Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum. Perinatal Exposure of Infants Born to HBsAg-positive Mothers Infants born to mothers positive for HBsAg with or without HBeAg12. Sexual Exposure to HBsAg-positive Persons Sexual partners of HBsAg-positive persons. Household Exposure to Persons with Acute HBV Infection Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient. Nabi-HB is indicated for intramuscular use only.
History
There is currently no drug history available for this drug.
Other Information
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
| HIV | BVD | PRV | EMC | PPV | |
| Model Virus: | HIV | HCV | HBV | Hepatitis A | PVB19 |
| Envelope/Genome: | Yes/RNA | Yes/RNA | Yes/DNA | No/RNA | No/DNA |
| Manufacturing Step | |||||
| Precipitation of Cohn | |||||
| Fraction III | Greater than 5.9 | 3.6 | 3.7 | 4.4 | 3.9 |
| Cuno Filtration | NT | NT | NT | Greater than 6.6 | 5.4 |
| Solvent/Detergent | Greater than 4.2 | Greater than 6.9 | Greater than 6.4 | NT | NT |
| Nanofiltration | Greater than 7.4 | Greater than 6.9 | Greater than 5.7 | 3.0 | 0.7 |
| Cumulative | Greater than 17.5 | Greater than 17.4 | Greater than 15.8 | Greater than 14.0 | 9.3 |
Sources
Nabi-hb Manufacturers
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Biotest Pharmaceuticals Corporation
![Nabi-hb (Human Hepatitis B Virus Immune Globulin) Injection [Biotest Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nabi-hb | Biotest Pharmaceuticals Corporation
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. Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure 12 Exposed Person Source Unvaccinated Vaccinated HBsAg-positive 1. Hepatitis B Immune Globulin (Human) X1 immediately 2. Initiate HB Vaccine series 1. Test exposed person for anti-HBs 2. If inadequate antibody, Hepatitis B immune Globulin (Human) X 1 immediately plus either HB Vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later Known Source - High Risk for HBsAG-Positive 1. Initiate HB Vaccine series 2. Test source for HBsAG. If positive, Hepatitis B Immune Globulin (Human)1 X 1. Test source for HBsAG only if exposed is vaccine nonresponder; if source is HBsAG-Positive, Give Hepatitis B Immune Globulin (Human) 1 X immediately plus either HB vaccine booster dose or second dose of Hepatitis B immune Globulin (Human) one month later. Known Source - Low Risk for HBsAG - Positive Initiate HB Vaccine series Nothing Required Unknown Source Initiate HB vaccine series Nothing Required 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. Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection 19 Age of Infant Administer Infant born to mother known to be HBsAG-Positive Infant born to mother not screened for HBsAG First Vaccination Birth (Within 12 hours) Birth (Within 12 hours) Hepatitis B Immune Globulin (Human) Birth (Within 12 hours) If mother is found to be HBsAG - positive, administer dose to infant as soon as possible, not later than 1 week after birth. Second Vaccination 1 month 1-2 months Third Vaccination 6 months 6 months 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. -
Biotest Pharmaceuticals Corporation
Nabi-hb | Biotest Pharmaceuticals Corporation
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. Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure 12 Exposed Person Source Unvaccinated Vaccinated HBsAg-positive 1. Hepatitis B Immune Globulin (Human) X1 immediately 2. Initiate HB Vaccine series 1. Test exposed person for anti-HBs 2. If inadequate antibody, Hepatitis B immune Globulin (Human) X 1 immediately plus either HB Vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later Known Source - High Risk for HBsAG-Positive 1. Initiate HB Vaccine series 2. Test source for HBsAG. If positive, Hepatitis B Immune Globulin (Human)1 X 1. Test source for HBsAG only if exposed is vaccine nonresponder; if source is HBsAG-Positive, Give Hepatitis B Immune Globulin (Human) 1 X immediately plus either HB vaccine booster dose or second dose of Hepatitis B immune Globulin (Human) one month later. Known Source - Low Risk for HBsAG - Positive Initiate HB Vaccine series Nothing Required Unknown Source Initiate HB vaccine series Nothing Required 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. Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection 19 Age of Infant Administer Infant born to mother known to be HBsAG-Positive Infant born to mother not screened for HBsAG First Vaccination Birth (Within 12 hours) Birth (Within 12 hours) Hepatitis B Immune Globulin (Human) Birth (Within 12 hours) If mother is found to be HBsAG - positive, administer dose to infant as soon as possible, not later than 1 week after birth. Second Vaccination 1 month 1-2 months Third Vaccination 6 months 6 months 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.
![Nabi-hb (Human Hepatitis B Virus Immune Globulin) Injection [Biotest Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=17fda474-4e87-4ca4-b5f5-0df5978f83b7&name=FrontPackageDisplay.jpg)
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