Flebogamma
Generic name:human immunoglobulin g
Dosage form: injection
Drug class:Immune globulins
Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.
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DESCRIPTION
Immune Globulin Intravenous (Human), Flebogamma® 5% (IGIV) is a sterile, clear or slightly opalescent and colorless to pale yellow, liquid, pasteurized preparation of highly purified immunoglobulin (IgG) obtained from human plasma pools. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography.
Flebogamma® 5% is a highly purified (≥ 99% IgG), unmodified, human IgG that contains the antibody specificities found in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG1, is 70.3%, IgG2, 24.7%, IgG3, 3.1%, and IgG4, 1.9% (1). The IgA content is < 0.05 mg/mL, and IgM is present in trace amounts.
In the final formulation, Flebogamma® 5% contains 50 mg IgG per mL, 50 mg D-sorbitol per mL, and ≤ 6 mg/mL polyethylene glycol. There is no preservative in the formulation. The pH of the solution ranges from 5 to 6 and the osmolarity from 240 to 350 mOsm/L.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be nonreactive (negative).
Virus elimination experiments have been performed on 2 steps of the production process. Residual viral titers were determined by infectivity assays. When no residual virus was detected, the Poisson distribution was used to give the minimum detectable level (MDL) based on the assay sensitivity and the sample volume used (1).
The viral reduction data (in log10) from these experiments are summarized in Table 1.
