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Efficacy of DigiFab®

DigiFab® delivers measurable results

While the signs and symptoms of digoxin toxicity can be hard to recognize, your treatment choice should be clear. In a clinical study, DigiFab® Digoxin Immune Fab (Ovine) was shown to be effective in the treatment of digoxin toxicity.1

  • 67% of patients had ECG abnormalities that improved within 4 hours
  • 47% of patients had complete resolution of all manifestations of toxicity within 4 hours
  • 93% of patients were classified as having resolved their digoxin toxicity by 20 hours
  • Serum free digoxin concentrations fell to undetectable concentrations in all patients following DigiFab® administration

Study Description

Results of a prospective multicenter study of the efficacy of DigiFab® Digoxin Immune Fab (Ovine) in patients presenting with life-threatening digoxin toxicity (N=15). Patients received doses of DigiFab® Digoxin Immune Fab (Ovine) based on its theoretical binding capacity for digoxin and the known amount of digoxin ingested or on blood concentrations of digoxin at the time of admission. Primary outcome measure was the serum level of free (unbound) digoxin.1

DigiFab® effectively addresses digoxin poisoning

DigiFab® Digoxin Immune Fab (Ovine) rapidly binds and neutralizes digoxin:

  1. Digoxin's inotropic effect results from the inhibition of the sodium-potassium adenosine triphosphatase pump1
  2. The affinity of DigiFab® for digoxin is greater than the affinity of digoxin for the receptor on the sodium-potassium pump1
  3. DigiFab® binds with digoxin and is sequestered in the extracellular fluid, thereby reducing cardiotoxicity1

The bound digoxin is then cleared by the kidneys and reticuloendothelial system.1

  • DigiFab® Digoxin Immune Fab (Ovine) rapidly reduced the level of free digoxin in the serum to undetectable levels2
  • More than 40% of the administered dose was excreted in the urine by 24 hours

Study Description

Results of a pharmacokinetic and pharmacodynamic study in healthy volunteers (N=16) who were administered a 1 mg intravenous dose of digoxin, followed 2 hours later by an equimolar neutralizing dose of digoxin immune Fab (ovine). The primary outcome measure was the serum level of free (unbound) digoxin.1

Read about administering DigiFab® »

References

  1. DigiFab® [prescribing information]. BTG International Inc. January 2012.
  2. Ward SB, Sjostrom L, Ujhelyi MR. Comparison of the Pharmacokinetics and In Vivo Bioaffinity of DigiTAb Versus Digibind. Ther Drug Monit 2000;22(5):599-607.

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