Overview
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.
Background
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
Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications.
Associated Conditions
- Reactivation of hepatitis B virus infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/05/17 | Phase 3 | Completed | |||
2012/01/20 | Phase 3 | Completed | |||
2010/05/26 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Saol Therapeutics Inc. | 70257-053 | INTRAVENOUS, INTRAMUSCULAR | 312 [iU] in 1 mL | 4/16/2020 | |
| ADMA Biologics, Inc. | 69800-4203 | INTRAMUSCULAR | 1560 [iU] in 5 mL | 11/22/2022 | |
| Saol Therapeutics Inc. | 70257-051 | INTRAVENOUS, INTRAMUSCULAR | 312 [iU] in 1 mL | 1/15/2019 | |
| Saol Therapeutics Inc. | 70257-052 | INTRAVENOUS, INTRAMUSCULAR | 312 [iU] in 1 mL | 1/15/2019 | |
| Saol Therapeutics Inc. | 70257-054 | INTRAVENOUS, INTRAMUSCULAR | 312 [iU] in 1 mL | 4/16/2020 | |
| ADMA Biologics, Inc. | 69800-4202 | INTRAMUSCULAR | 312 [iU] in 1 mL | 11/22/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/30/2009 | ||
Authorised | 11/30/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HyperHEP B Pre-filled Syringe 1mL | SIN13491P | INJECTION | 15-18% | 7/15/2008 | |
| HEPATECT CP SOLUTION FOR INFUSION 50 IU/ML | SIN14652P | INFUSION, SOLUTION | 50 iu/ml | 10/24/2014 | |
| HyperHEP B INJECTION | SIN09669P | INJECTION | 15 - 18% | 3/7/1998 | |
| HyperHEP B Pre-filled Syringe 0.5mL | SIN13490P | INJECTION | 15-18% | 7/15/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||