Flebogamma 5%

Description

Immune Globulin Intravenous (Human), Flebogamma 5% (IGIV) is a sterile, clear or slightly opalescent and colorless to pale yellow, liquid pasterurized 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: IgG 1 is 70.3%, IgG 2 , 24.7%, IgG 3 , 3.1%, and IgG 4 , 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).

Warnings

Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death (6). Patients predisposed to acute renal failure include patients witn any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Flebogamma 5% does not contain sucrose.

See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections for important information intended to reduce the risk of acute renal failure.

How Supplied

Flebogamma 5% is supplied in the following vial sizes:

NDC Number Size Grams IgG
61953-0003-01  10 mL 0.5
61953-0003-02  50 mL 2.5
61953-0003-03 100 mL 5
61953-0003-04 200 mL 10

STORAGE

Store at + 2 to + 25 °C (36 to 77 °F). Do not freeze. Discard after expiration date.

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