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Bayhep B (Hepatitis B Immune Globulin) - Summary

 
 



BAYHEP B SUMMARY

Hepatitis B Immune Globulin (Human) -- BayHep B® treated with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayHep B 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. BayHep B is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayHep B is then incubated in the final container for 21-28 days at 20-27°C. Each vial contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 217 international units (IU) per mL.

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.8

BayHep B is indicated for post-exposure prophylaxis in the following situations:

After either parenteral exposure, e.g., by accidental "needlestick" or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin (Human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting.

Infants born to HBsAg-positive mothers are at risk of being infected with hepatitis B virus and becoming chronic carriers.5,8-10 This risk is especially great if the mother is HBeAg-positive.11-13 For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%-95% effective in preventing development of the HBV carrier state.8,14 Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have 70%-90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has only 50% efficacy.8,15

Sex partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. For sexual exposure to a person with acute hepatitis B, a single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within 2 weeks of last sexual exposure.8

Since infants have close contact with primary care-givers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection.8

Administration of Hepatitis B Immune Globulin (Human) either preceding or concomitant with the commencement of active immunization with Hepatitis B Vaccine provides for more rapid achievement of protective levels of hepatitis B antibody, than when the vaccine alone is administered.16 Rapid achievement of protective levels of antibody to hepatitis B virus may be desirable in certain clinical situations, as in cases of accidental inoculations with contaminated medical instruments.16 Administration of Hepatitis B Immune Globulin (Human) either 1 month preceding or at the time of commencement of a program of active vaccination with Hepatitis B Vaccine has been shown not to interfere with the active immune response to the vaccine.16


See all Bayhep B indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Bayhep B (Hepatitis B Immune Globulin)

Efficacy and tolerability of diphenyl-dimethyl-dicarboxylate plus garlic oil in patients with chronic hepatitis. [2012]
patients... CONCLUSIONS: The 6-week treatment of DDB plus GO lowered serum aminotransferase

Chinese medicine for treatment of chronic hepatitis B. [2012]
Contemporary Western medicines approved by the U.S.Components of CM deserve further study in pre-clinical models of HBV infection and in clinical trials world-wide.

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C. [2012]
therapy... CONCLUSIONS: The challenges identified and addressed during development of this

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C. [2011.11.04]
BACKGROUND: Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. PURPOSE: We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy... CONCLUSIONS: The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products. Clinical Trials 2011; XX: 1 -11. http://ctj.sagepub.com.

Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. [2011.07]
BACKGROUND: A modified process hepatitis B vaccine (mpHBV) uses higher phosphate content in the manufacturing process relative to the current product, Recombivax-HB. The higher phosphate is thought to improve antigen presentation, and thereby, increase antibody production. The mpHBV was previously shown to be well tolerated and immunogenic in adults. The current study tested a 2-, 4-, 6-month vaccination schedule and a higher dose formulation (10 mug mpHBV) in healthy infants... CONCLUSIONS: All 4 hepatitis B vaccines elicited high anti-HBs SPRs. After dose 3, anti-HBs GMT were highest in the 10 mug mpHBV group, but did not meet the predefined criteria for superiority. All vaccines were well tolerated.

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Clinical Trials Related to Bayhep B (Hepatitis B Immune Globulin)

Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients [Recruiting]
HepaGam B Hepatitis B Immune Globulin (HBIG) solution contains 10% maltose, which could possibly interfere with the measurement of glucose levels when using glucose non-specific tests. The purpose of this study is to determine whether use of HepaGam B HBIG shows an increase in glucose levels in the body using non-specific glucose monitoring, as well as specific glucose monitoring. The sponsor believes that this medication will not cause a significant increase in glucose levels in the body when measured by glucose non-specific tests.

Evaluation of HepaGam B� in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients [Recruiting]
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.

Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation [Not yet recruiting]
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.

Efficacy and Safety of Niuliva for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients [Recruiting]
The aim of this clinical trial is to evaluate the efficacy and safety of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as protective during the first six months post-transplantation.

In addition, the safety and tolerability of the administration of Niuliva will also be assessed.

Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth. [Not yet recruiting]
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.

more trials >>


Page last updated: 2013-02-10

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