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Baygam (Immune Globulin Human) - Summary



Immune Globulin (Human) -- BayGam® treated with solvent/detergent is a sterile solution of immune globulin for intramuscular administration; it contains no preservative. BayGam is prepared by cold ethanol fractionation from human plasma. 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. BayGam is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayGam is then incubated in the final container for 21-28 days at 20-27°C.

The prophylactic value of BayGam is greatest when given before or soon after exposure to hepatitis A. BayGam is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

BayGam should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.7 A susceptible person is one who has not been vaccinated and has not had measles previously. BayGam may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.7 BayGam and measles vaccine should not be given at the same time. 7 If a child is older than 12 months and has received BayGam, he should be given measles vaccine about 3 months later when the measles antibody titer will have disappeared.

If a susceptible child exposed to measles is immunocompromised, BayGam should be given immediately.8 Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.

Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZIG]. If VZIG is unavailable, BayGam, promptly given, may also modify varicella.5

The routine use of BayGam for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.6 Some studies suggest that the use of BayGam in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, BayGam may benefit those women who will not consider a therapeutic abortion.4

In patients with immunoglobulin deficiencies, BayGam may prevent serious infection. However, BayGam may not prevent chronic infections of the external secretory tissues such as the respiratory and gastrointestinal tract.

Prophylactic therapy, especially against infections due to encapsulated bacteria, is effective in Bruton-type, sex-linked, congenital agammaglobulinemia, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.

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Published Studies Related to Baygam (Immune Globulin Human)

Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans. [2015]
humans... CONCLUSIONS: These data demonstrate that a single intramuscular administration of

Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis: a randomized controlled clinical trial. [2014]
studied... CONCLUSIONS: These results demonstrate an immunological effect of anatabine on

Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): a phase II double-blind placebo-controlled trial. [2014]
biomarkers... CONCLUSIONS: These results confirm tolerability and safety of this novel

LADA and CARDS: a prospective study of clinical outcome in established adult-onset autoimmune diabetes. [2014]
CONCLUSIONS: Adult-onset autoimmune diabetes was prevalent, even in patients with

Evaluation of intravenous anthrax immune globulin for treatment of inhalation anthrax. [2013]
Bacillus anthracis toxins can be neutralized by antibodies against protective antigen (PA), a component of anthrax toxins. Anthrivig (human anthrax immunoglobulin), also known as AIGIV, derived from plasma of humans immunized with BioThrax (anthrax vaccine adsorbed), is under development for the treatment of toxemia following exposure to anthrax spores.

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Clinical Trials Related to Baygam (Immune Globulin Human)

Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma [Active, not recruiting]
This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma. Chemotherapy(cyclophosphamide), prednisone and intravenous gamma globulin all suppress the immune system which may be helpful in treating opsoclonus-myoclonus-ataxia (OMA).

Immune Globulin Subcutaenous (Human), 20% [Completed]
The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases.

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Page last updated: 2015-08-10

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