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Digibind
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  • FDA PI

Digibind

Generic name:digoxin immune fab (ovine)
Dosage form: injection, powder, for solution
Drug class:Antidotes

Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.

Digibind Description

Digibind, Digoxin Immune Fab (Ovine), is a sterile lyophilized powder of antigen binding fragments (Fab) derived from specific antidigoxin antibodies raised in sheep. Production of antibodies specific for digoxin involves conjugation of digoxin as a hapten to human albumin. Sheep are immunized with this material to produce antibodies specific for the antigenic determinants of the digoxin molecule. The antibody is then papain-digested and digoxin-specific Fab fragments of the antibody are isolated and purified by affinity chromatography. These antibody fragments have a molecular weight of approximately 46,200.

Each vial, which will bind approximately 0.5 mg of digoxin (or digitoxin), contains 38 mg of digoxin-specific Fab fragments derived from sheep plus 75 mg of sorbitol as a stabilizer and 28 mg of sodium chloride. The vial contains no preservatives.

Digibind is administered by intravenous injection after reconstitution with Sterile Water for Injection (4 mL per vial).

Digibind - Clinical Pharmacology

After intravenous injection of Digoxin Immune Fab (Ovine) in the baboon, digoxin-specific Fab fragments are excreted in the urine with a biological half-life of about 9 to 13 hours.1 In humans with normal renal function, the half-life appears to be 15 to 20 hours.2 Experimental studies in animals indicate that these antibody fragments have a large volume of distribution in the extracellular space, unlike whole antibody which distributes in a space only about twice the plasma volume.1 Ordinarily, following administration of Digibind, improvement in signs and symptoms of digitalis intoxication beg...