Prescribing Information Summary of Product Characteristics
digoxin immune fab digifab logo DIGIFab

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Efficacy

DIGIFab® Resolved Life-Threatening Digoxin Toxicity Within Hours

  • DIGIFab® rapidly neutralised free digoxin to resolve the cardiotoxic effects and other clinical manifestations of known (or strongly suspected) life-threatening digoxin toxicity.1,2

DIGIFab® rapidly neutralised free digoxin to undetectable levels1,2*

digoxin-toxicity-treatment-digifab-efficacy-chart

In this comparative pharmacokinetic study, 16 healthy subjects were administered 1 mg intravenous digoxin followed2 hours later by 30-minute infusion of an approximately equimolar neutralising dose of DIGIFab® (n=8) or Digibind® (digoxin immune fab) (n=8). Serum free digoxin levels were analysed at predetermined time intervals (0.5, 1, 2, 4, 6, 10, 22, and 46 hours after DIGIFab® administration).

DIGIFab® Rapidly Resolved the Cardiotoxic Effects and Other Clinical Manifestations of
Life-Threatening Digoxin Toxicity 1,2†

digoxin-immune-fab-digifab-neutralizes-image

Serum free digoxin
 concentrations were
 undetectable in all patients1**

digoxin-toxicity-early-recognition-image

ECG abnormalities
resolved within 4 hours
in 67% of patients2

digoxin-immune-fab-digifab-clinically-proven-image

Complete resolution of
toxicity was achieved within: 
4 hours in 47% of patients
20 hours in 93% of patients2 

  • The most common adverse reactions (>7%) related to DIGIFab® administration were worsening congestive heart failure (13%), hypokalaemia (13%), and worsening atrial fibrillation (7%).1,2†

Results from a prospective, multicentre safety, efficacy, and pharmacokinetic study in patients presenting with life-threatening digoxin toxicity (n=15) conducted in the United States and Finland. Results were compared with historical data on Digibind®. Patients received doses of DIGIFab® based on its theoretical binding capacity for digoxin and based on the known amount of digoxin ingested or on blood concentrations of digoxin at the time of admission.

**Serum free digoxin concentrations were measured at the end of DIGIFab® infusion (30 minutes in duration).

References

  1. Data on file. BTG International Ltd.
  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.
  3. DIGIFab Digoxin Immune Fab (ovine) Summary of Product Characteristics (SmPC).