| Primary information |
|---|
| ThPP ID | Th1183 |
| Therapeutic Peptide/Protein Name | Hepatitis B immune globulin |
| Sequence | NA view full sequnce in fasta |
| Functional Classification | IIIa |
| 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 |
| Volume of Distribution | approximately 7.5 L |
| Clearance | The mean clearance rate was 0.21 to 0.24 L/day |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | HBsAg |
| Information of corresponding available drug in the market |
|---|
| Brand Name | Hyperhep B S/d |
| Company | GRIFOLS USA, LLC |
| Brand Discription | HyperHEP B® S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperHEP B S/D is prepared by cold ethanol fractionation from the plasma of donors with high titers of antibody to the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperHEP B S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperHEP B S/D is then incubated in the final container for 21–28 days at 20–27°C. |
| Prescribed for | Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice. Also for post-exposure prophyllaxis for Acute Exposure To Blood Containing HBsAg, Perinatal Exposure Of Infants Born To HBsAg-positive Mothers, Sexual Exposure To An HBsAg-positive Person and Household Exposure To Persons With Acute HBV Infection. |
| Chemical Name | NA |
| Formulation | 220 [iU]/mL |
| Physcial Appearnce | 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 | NA |
| Side Effects | Local pain and tenderness at the injection site, urticaria and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. |
| Useful Link | http://www.rxlist.com/hyperhep-b-drug/side-effects-interactions.htm |
| PubMed ID | 23239274, 28209492, 28199772, 27439498, 27422771, 27298109, 27255707, 26859222, 26713590 |
| 3-D Structure | N.A. |