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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 clinical studies, DigiFab® Digoxin Immune Fab (Ovine) was shown to be effective in the treatment of digoxin toxicity.

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

  • 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

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:

Digifab neutralizes digoxin chart

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 levels
  • 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

General Precautions

Standard management of digitalis intoxication includes withdrawal of the intoxicating agent, correction of electrolyte disturbances (especially hyperkalemia), acid-base imbalances, hypoxia and treatment of cardiac arrhythmias.

Massive digitalis intoxication can cause hyperkalemia; administration of potassium supplements in the setting of digitalis intoxication may be hazardous. After treatment with DigiFab® Digoxin Immune Fab (Ovine), the serum potassium concentration may drop rapidly and must be monitored frequently, especially after the first several hours after DigiFab® Digoxin Immune Fab (Ovine) is given.

Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab® Digoxin Immune Fab (Ovine). If needed, additional support can be provided by using other intravenous inotropes such as dopamine, dobutamine, or vasodilators.

However, care must be taken not to aggravate the digitalis-induced rhythm disturbances. Re-digitalization should be postponed, if possible, until the Fab fragments have been eliminated from the body, which may require several days, and patients with impaired renal function may require a week or longer.

For full safety information, please see Prescribing Information.

Read about administering DigiFab® »

To report an adverse event or for 24-hour medical information, call 1-844-293-0007.

References
  1. DigiFab® [prescribing information]. BTG International Inc. January 2012.
  2. Schreiber D. Toxicity, digitalis. eMedicine from WebMD Web site. http://emedicine.medscape.com/article/814404-print. Updated December 2, 2009. Accessed June 11, 2010.

Indication
DigiFab® Digoxin Immune Fab (Ovine) is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. DigiFab® is not indicated for milder cases of digitalis toxicity.

Important Safety Information
Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab®.  Rapid drop in serum potassium concentration may occur after treatment with DigiFab®. Patients with known allergies to sheep protein, papaya, or papain are at higher risk of an anaphylactic reaction. Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked. The most common adverse reactions (>7%) related to DigiFab® are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). Please see full prescribing information, including events, precautions, or warnings.