Drug intelligence / Profile preview

human normal immunoglobulin (Bio Products Laboratory)

Development stage
Approved
Lead developer
Bio Products Laboratory
Administration
Intravenous
01

Overview

Gammaplex is a plasma-derived intravenous immunoglobulin (IVIG) product containing human normal immunoglobulin G (IgG). Developed and manufactured by Bio Products Laboratory (BPL), it is available in two formulations: a 5% solution and a 10% solution stabilized with glycine. The drug is FDA-approved for the treatment of primary immunodeficiency (PI) in patients aged 2 years and older, and for chronic immune thrombocytopenic purpura (ITP) in adults. Its mechanism of action involves providing a broad spectrum of opsonizing and neutralizing IgG antibodies, which serves as replacement therapy in PI and modulates the immune system to prevent platelet destruction in ITP. Common adverse reactions include headache, vomiting, nausea, pyrexia, and arthralgia.

Brand names
Gammaplex
Other names
immune globulin intravenous (human)IVIGGammaplex 5%Gammaplex 10%
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)C3/C4 (Complement components C3/C4 and active fragments)

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