|
| Primary information |
|---|
| ID | 10792 |
| Therapeutic ID | Th1183 |
| Protein Name | Hepatitis B immune globulin |
| Sequence | NA
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | 22-25 days |
| Description | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. |
| Indication/Disease | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. |
| Pharmacodynamics | NA |
| Mechanism of Action | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | NA |
| NA |
| Clearance | NA |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | HBsAg |
| Brand Name | Nabi-HB |
| Company | Biotest Pharmaceuticals Corporation |
| Brand Description | Biotest Pharmaceuticals Corporation |
| Prescribed For | 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; Perinatal Exposure of Infants Born to HBsAg-positive Mothers; Sexual Exposure to HBsAg-positive Persons; Household Exposure to Persons with Acute HBV Infection. |
| Chemical Name | NA |
| Formulation | 312 [iU]/mL |
| Physical Appearance | Injection |
| Route of Administration | Intramuscular |
| Recommended Dosage | For Acute Exposure To Blood Containing HBsAg: For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated, 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 Hepatitis B Vaccine package insert for dosage information regarding that product; for Prophylaxis Of Infants Born To HBsAg And HBeAg Positive Mothers: Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery; For Sexual Exposure To An HBsAg-positive Person: All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection; For Household Exposure To Persons With Acute HBV Infection: Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants 12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had 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 vaccine. |
| Contraindication | ndividuals 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 (hepatitis b vaccine recombinant) contains less than 100 micrograms per mL IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylac-toid reaction. The physician must weigh the potential benefit of treatment with Nabi-HB (hepatitis b vaccine recombinant) against the potential for hypersensitivity reactions |
| Side Effects | The number of patients with reactions related to the administration of Nabi-HB (hepatitis b vaccine recombinant) included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myal-gia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the phar-macokinetics trials and were considered probably related to Nabi-HB (hepatitis b vaccine recombinant) : elevated alkaline phos-phatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events. No anaphylactic reactions with Nabi-HB (hepatitis b vaccine recombinant) have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |