26 It is very similar to Digibind, except that it is prepared using a digoxin derivative (digoxin-dicarboxymethoxylamine) as the hapten. 25 Another commercial product, DigiFab, approved by the US Food and Drug Administration (FDA) in 2001, is currently available. 14, 48, 51, 53 In 1976, Digibind was used with clinical success, 81 and it became commercially available in 1986 before being discontinued in 2011. When compared with whole IgG antibodies, the advantages of DSFab included a larger volume of distribution (Vd), more rapid onset of action, diminished risk of adverse immunologic effects, and more rapid elimination. Since the Fc fragment does not bind antigen and increases the potential for hypersensitivity reactions, it was eliminated. 14 Affinity chromatography is used to isolate and purify the DSFab following papain digestion. To make such antibodies both safe and effective in humans, whole IgG antidigoxin antibodies were cleaved with papain, yielding two antigen-binding fragments (Fab), with a molecular weight of 50,000 Da each, and one Fc fragment of 50,000 Da. Furthermore, there was significant concern with regard to the development of hypersensitivity reactions. 14 Unfortunately, the urinary excretion of digoxin was delayed, and free digoxin was released after antibody degradation occurred. Sheep are immunized with this material to produce antibodies specific. Production of antibodies specific for digoxin involves conjugation of digoxin as a hapten to human albumin. Intact IgG antidigoxin antibodies reversed digoxin toxicity in dogs. DIGIBIND, Digoxin Immune Fab (Ovine), is a sterile lyophilized powder of antigen binding fragments (Fab) derived from specific antidigoxin antibodies raised in sheep.
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