Drug intelligence / Profile preview

immune globulin subcutaneous, human-klhw

Development stage
Approved
Lead developer
Grifols
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Xembify is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older. It supplies a broad spectrum of opsonizing and neutralizing immunoglobulin G (IgG) antibodies against bacterial, viral, parasitic, and mycoplasmal agents and their toxins. Xembify also contains antibodies capable of interacting with and altering the activity of cells of the immune system. The solution is clear to slightly opalescent, and colorless or pale yellow, with a purity of ≥98% IgG and a sub-class distribution similar to that found in normal serum. It consists of 18% to 22% protein in 0.16 M to 0.26 M glycine and 10 to 40 mcg/mL polysorbate 80 at a pH of 4.1 to 4.8.

Brand names
Xembify
Other names
immune globulin subcutaneous, human-klhw
02

Targets

NeuraminidaseFcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)

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