DIGIFAB® Digoxin Immune Fab (Bovine)

BTG International Inc.

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Name DIGIFAB® Digoxin Immune Fab (Bovine)
Description DigiFab has an affinity for digoxin in the range of 109 to 1010 M-1, which is greater than the affinity of digoxin for its sodium pump receptor, the presumed receptor for its therapeutic and toxic effects. When administered to the intoxicated patient, DigiFab binds to molecules of digoxin reducing free digoxin levels, which results in a shift in the equilibrium away from binding to the receptors, thereby reducing cardio-toxic effects. Fab-digoxin complexes are then cleared by the kidney and reticuloendothelial system.
Active Ingredient digoxin-immune ovine Fab (monovalent) immunoglobulin fragments
Indication DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Although designed specifically to treat digoxin overdose, a product very similar to DigiFab (Digibind) has been used successfully to treat life-threatening digitoxin overdose. Since human experience is limited, and the consequences of repeated exposure are unknown, DigiFab is not indicated for milder cases of digitalis toxicity. Clinical conditions requiring administration of DigiFab include:

  • Known suicidal or accidental consumption of fatal doses of digoxin, including ingestion of 10 mg or more of digoxin in previously healthy adults, 4 mg (or more than 0.1 mg/kg) in previously healthy children, or ingestion causing steady state serum concentrations greater than 10 ng/mL;
  • Chronic ingestions causing steady-state serum digoxin concentrations exceeding 6 ng/mL in adults or 4 ng/mL in children; and
  • Manifestations of life-threatening toxicity due to digoxin overdose, including severe ventricular arrhythmias (such as ventricular tachycardia or fibrillation), progressive bradycardia, and second or third degree heart block not responsive to atropine, serum potassium levels exceeding 5.5 mEq/L in adults or 6 mEq/L in children with rapidly progressive signs and symptoms of digoxin toxicity.
Strengths 40 mg of digoxin immune Fab