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1763 details
Primary information
ThPP IDTh1183
Therapeutic Peptide/Protein NameHepatitis B immune globulin
SequenceNA view full sequnce in fasta
Functional ClassificationIIIa
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half Life22-25 days
DescriptionLong-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/DiseaseInvestigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications.
PharmacodynamicsNA
Mechanism of ActionIn 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.
ToxicityNA
MetabolismNA
AbsorptionNA
Volume of Distributionapproximately 7.5 L
ClearanceThe mean clearance rate was 0.21 to 0.24 L/day
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetHBsAg
Information of corresponding available drug in the market
Brand NameNabi-HB
CompanyBiotest Pharmaceuticals Corporation
Brand DiscriptionNabi-HB (hepatitis b vaccine recombinant) , is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs.
Prescribed forNabi-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 NameNA
Formulation1560 [iU]/5mL
Physcial AppearnceInjection
Route of AdministrationIntramuscular
Recommended DosageFor 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.
Contraindicationndividuals 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 EffectsThe 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 Linkhttp://www.rxlist.com/nabi-hb-drug/side-effects-interactions.htm
PubMed ID23239274, 28209492, 28199772, 27439498, 27422771, 27298109, 27255707, 26859222, 26713590
3-D StructureN.A.