Important Safety Information Full Prescribing Information
DIGIFab

This website is intended for US Healthcare Professionals only

Order DIGIFab
1.844.293.0007

Early Recognition of Digoxin Toxicity

Early Recognition of Digoxin Toxicity Is Essential

  • Early recognition of potentially life-threatening digoxin toxicity may result in improved treatment outcomes.1,2
  • Signs of potentially life-threatening digoxin toxicity include life-threatening or hemodynamically unstable cardiac
    dysrhythmias, hyperkalemia, and evidence of end-organ dysfunction from hypoperfusion.2
  • Cardiac effects are of the greatest concern in patients with digoxin toxicity.2

Don't miss the signs of potentially life-threatening digoxin toxicity

Signs of digoxin toxicity include:

digoxin-toxicity-signs-cardiac-arrhythmias-image

Cardiac Dysrhythmias3,4

  • Severe ventricular dysrhythmias
  • Progressive bradydysrhythmias
expand-icon
digoxin-toxicity-signs-cardiac-arrhythmias-image
  • Severe ventricular dysrhythmias3,4
    (eg, ventricular tachycardia, ventricular fibrillation)
  • Progressive bradydysrhythmias3,4
    (eg, severe sinus bradycardia, second- or third-degree heart block unresponsive to atropine)
collapse-icon
digoxin-toxicity-signs-laboratory-parameters-image

Laboratory Parameters2,3

  • Severely elevated serum potassium levels with rapidly progressive signs and symptoms
  • Severely elevated serum digoxin levels with clinically significant signs and symptoms
expand-icon
digoxin-toxicity-signs-laboratory-parameters-image
  • Severely elevated serum potassium levels with rapidly progressive signs and symptoms2
    (eg, >5.5 mEq/L in adults or >6 mEq/L in children)
  • Severely elevated serum digoxin levels with clinically significant signs and symptoms2,3
    (eg, steady state concentrations >6 ng/mL in adults or >4 ng/mL in children)
collapse-icon
digoxin-toxicity-signs-end-organ-dysfunction-image

Evidence of End-Organ Dysfunction2

  • Signs and symptoms of end-organ dysfunction from hypoperfusion
expand-icon
digoxin-toxicity-signs-end-organ-dysfunction-image
  • Signs and symptoms of end-organ dysfunction from hypoperfusion2 (eg, renal failure, altered mental status, abdominal pain)
collapse-icon
lines
digoxin-toxicity-signs-immediate-intervention-image

Any ONE
may indicate the need for
IMMEDIATE INTERVENTION2,3

Deliver THE Antidote

For potentially life-threatening digoxin toxicity, think R.A.P.I.D.1-3

Recognize. Act. Promptly Infuse DIGIFab.

View Efficacy Data
digoxin-toxicity-ecg-reference-tool-image

Various cardiac dysrhythmias may be associated
with potentially life-threatening digoxin toxicity3,4

View ECG Reference Tool

References

  1. Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325.
  2. Levine MD, O’Connor A. Digitalis (cardiac glycoside) poisoning. UpToDate. Updated January 2020. https://www.uptodate.com/contents/digitalis-cardiac-glycoside-poisoning. Accessed October 2, 2020.
  3. DIGIFab Digoxin Immune Fab (ovine) [package insert]. West Conshohocken, PA: BTG International Inc.; 2017.
  4. Goldberger AL, Traub SJ. Cardiac arrhythmias due to digoxin toxicity. Updated January 2020. UpToDate. https://www.uptodate.com/contents/cardiac-arrhythmias-due-to-digoxin-toxicity. Accessed October 2, 2020.

INDICATIONS AND USAGE

DIGIFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including:

  • Known suicidal or accidental consumption of fatal doses of digoxin: 10 mg or more of digoxin in healthy adults, or 4 mg (or more than 0.1 mg/kg) in healthy children, or ingestion of an amount that can cause steady state serum concentrations of ≥10 ng/mL;
  • Chronic ingestions causing steady-state serum digoxin concentrations >6 ng/mL in adults or 4 ng/mL in children;
  • Manifestations of life-threatening toxicity of digoxin overdose such as severe ventricular arrhythmias, 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.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

General

Suicidal ingestion may result from more than one drug. Consider toxic effects of other drugs or poisons in cases where signs and symptoms of digitalis toxicity are not relieved by administration of DIGIFab.

Rapid drop in serum potassium concentration may occur after treatment. Monitor frequently.

Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DIGIFab. Monitor frequently and provide additional inotropic support if needed. Postpone re-digitalization, if possible, until the Fab fragments have been eliminated; this may require several days or a week or longer in patients with impaired renal function.

Hypersensitivity Reactions

Anaphylaxis and hypersensitivity reactions are possible. Carefully monitor patients for signs and symptoms of an acute allergic reaction and if one occurs, stop the infusion and treat immediately with appropriate emergency medical care.

Patients with known allergies to sheep protein or those who have previously received intact ovine antibodies or Fab are particularly at risk for an anaphylactic reaction.

Do not administer DIGIFab to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.

Use of DIGIFab in Renal Failure

The elimination half-life of DIGIFab in renal failure has not been clearly defined. Monitor patients with severe renal failure who receive DIGIFab for a prolonged period for possible recurrence of toxicity. Monitoring of free (unbound) digoxin concentrations after the administration may be appropriate.

Laboratory Tests

DIGIFab may interfere with digitalis immunoassay measurements. Thus, standard serum digoxin concentration measurements may be clinically misleading until the Fab fragments are eliminated from the body. This may take several days or a week or more in patients with markedly impaired renal function. If possible, obtain serum digoxin samples before DIGIFab administration to establish the level of serum digoxin at the time of diagnosis.

The total serum digoxin concentration may rise precipitously following administration of DIGIFab, but this will be almost entirely bound to the Fab fragment and not able to react with receptors in the body.

Adverse Reactions

The most common adverse reactions (>7%) related to DIGIFab administration are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%).

Please see full Prescribing Information.