ABSTRACT
Intravenous immunoglobulin (IVIg) is derived from human plasma by recovery from whole blood donors or by plasmapheresis. Prior to 1981, only products that had a modified Fc function were commercially available from manufacturers. These products were used in a limited manner for immune replacement in patients with defective IgG. The second-generation products, with an intact Fc function, have allowed the use of IVIg for broader immune replacement therapy in patients with defective B-cell function(s) and in immune modulation. This has resulted in the significant increase in the use of IVIg in autoimmune disorders, including those in dermatology. Current applications include dermatomyositis, Kawasaki’s disease, bullous pemphigoid, linear IgA, ocular cicatricial pemphigoid, toxic epidermal necrolysis, chronic urticaria and atopic dermatitis. Table 9.1 IVIg Information chart
Pharmacology
IVIg products are not generics nor are considered equivalent. The USA Food and Drug Administration (FDA) considers each biological a new molecule, thereby not allowing their registration as generics. Manufacturers only purify the IgG protein (Fig. 9.1). They cannot improve on what the human body makes, only damage the molecule during purification or through the addition of various excipients. Most adverse reactions are the result of the purification process and/ or the addition of excipients. These differences are very evident when the properties are compared side by side. Table 9.1 lists those products available in Europe and the United States. The data are taken directly from the manufacturers’ own promotional literature and package leaflets.
