A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Baygam Pharmacology, Pharmacokinetics, Studies, Metabolism - Immune Globulin
Baygam Pharmacology, Pharmacokinetics, Studies, Metabolism - Immune Globulin
CLINICAL PHARMACOLOGY
Peak levels of immunoglobulin G are obtained approximately 2 days after intramuscular
injection of BayGam. 1 The half-life of IgG in the circulation of
individuals with normal IgG levels is 23 days. 2
Passive immunization with BayGam modifies hepatitis A, prevents or modifies
measles, and provides replacement therapy in persons with hypogammaglobulinemia
or agammaglobulinemia. BayGam is not standardized with respect to antibody titers
against hepatitis B surface antigen (HBsAg) and should not be used for prophylaxis
of viral hepatitis type B. Prophylactic treatment to prevent hepatitis B can
best be accomplished with use of Heptitis B Immune Globulin (Human), often in
combination with Hepatitis B Vaccine. 3
BayGam may be of benefit in women who have been exposed to rubella in the first
trimester of pregnancy and who will not consider a therapeutic abortion. 4
BayGam may also be considered for use in immunocompromised patients for
passive immunization against varicella if Varicella-Zoster Immune Globulin (Human)
is not available. 5
Immune Globulin (Human) is not indicated for routine prophylaxis or treatment
of rubella, poliomyelitis, mumps, or varicella. It is not indicated for allergy
or asthma in patients who have normal levels of immunoglobulin. 6
In a clinical study in eight healthy human adults receiving another hyperimmune
immune globulin product treated with solvent/detergent, Rabies Immune Globulin
(Human), BayRab™, prepared by the same manufacturing process, detectable passive
antibody titers were observed in the serum of all subjects by 24 hours post
injection and persisted through the 21 day study period. These results suggest
that passive immunization with immune globulin products is not affected by the
solvent/detergent treatment.
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