Important Safety Information Full Prescribing Information
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Early Recognition of Digoxin Toxicity

Early Recognition of Digoxin Toxicity Is Essential

Digoxin Toxicity May Be Difficult to Recognize1

Digoxin toxicity symptoms are often nonspecific and may be similar to those commonly observed as part of the normal aging process1

Neurologic symptoms

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Headache, confusion, altered mental status, vertigo, trigeminal neuralgia and other neuralgias, convulsions, paresthesia, delirium, psychosis, hallucinations1

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Cardiac symptoms

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Worsening of heart failure, atrial arrhythmias, AV block, ventricular arrhythmias, AV nodal arrhythmias1

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Gastrointestinal symptoms

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Anorexia, nausea, vomiting, diarrhea, abdominal pain, constipation, intestinal ischemia1

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Visual symptoms

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Blurring, color changes: particularly green or yellow hues with possible halos, rarely: scotomas micropsia, macropsia, amblyopias1

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General symptoms

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Fatigue, malaise, insomnia, loss of interest, depression, anxiety, restlessness, weakness1

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Other rare symptoms

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Urticaria, eosinophilia, thrombocytopenia, gynecomastia, maculopapular rash, hyperkalemia1

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Any Indication of Potentially Life-Threatening Digoxin Toxicity May Necessitate the Need for Immediate Intervention.

Signs of potentially life-threatening digoxin toxicity include:

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Cardiac Dysrhythmias3,4

  • Severe ventricular dysrhythmias
  • Progressive bradydysrhythmias
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  • Ventricular tachydysrhythmias are more common in chronic or late acute digoxin toxicity5
  • Early bradydysrhythmias in acute toxicity are often responsive to atropine5
  • Bradydysrhythmias in chronic or late acute digoxin toxicity are often minimally responsive to atropine5
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Laboratory Parameters2,3

  • Severely elevated serum potassium concentrations with rapidly progressive signs and symptoms
  • Severely elevated serum digoxin concentrations with clinically significant signs and symptoms
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  • Hyperkalemia (e.g., >5.5 mEq/L in adults or >6 mEq/L in children) frequently occurs in acute digoxin toxicity and is an important predictor of mortality3,5
  • Severely elevated digoxin levels (e.g., steady-state concentrations >6 ng/mL in adults or >4 ng/mL in children) can lead to potentially life-threatening toxicity3
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Evidence of End-Organ Dysfunction2

  • Signs and symptoms of end-organ dysfunction from hypoperfusion
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  • Signs and symptoms include renal failure, altered mental status, abdominal pain2
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Any ONE
may indicate the need for
IMMEDIATE INTERVENTION2,3

Deliver THE Antidote

Digoxin toxicity can occur at therapeutic concentrations and levels do not always correlate with clinical manifestations.
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  • In acute ingestions, obtaining an immediate digoxin concentration in patients with toxicity does not necessarily correlate with toxicity severity and can be misleading, as clinical manifestations are a result of tissue penetration that often lags behind peak serum concentrations6,7
  • Chronic digoxin toxicity may occur at typical therapeutic digoxin concentrations due to electrolyte imbalance or drug-drug interactions2,5,6


See how digoxin can lead to potentially life-threatening toxicity and understand signs and symptoms to look for.

Review clues that may point to potentially life-threatening digoxin toxicity and the importance of immediate intervention.

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For potentially life-threatening digoxin toxicity, think R.A.P.I.D.2,3

Recognize. Act. Promptly Infuse DIGIFab

View Efficacy Data
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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 April 2020. Accessed November 21, 2023. https://www.uptodate.com/contents/digitalis-cardiac-glycoside-poisoning
  3. DIGIFab Digoxin Immune Fab (ovine) [package insert]. BTG International Inc.; 2017.
  4. Goldberger AL, Traub SJ. Cardiac arrhythmias due to digoxin toxicity. UpToDate. Updated June 2020. Accessed November 21, 2023. https://www.uptodate.com/contents/cardiac-arrhythmias-due-to-digoxin-toxicity
  5. Hack JB. Hack JB. In: Nelson LS, Howland MA, Lewin NA, Smith SW, Goldfrank LR. Cardioactive Steroids. Goldfrank’s Toxicologic Emergencies, 11th ed. McGraw-Hill Education; 2019:969-976.
  6. Digoxin oral solution [package insert]. Roxane Laboratories, Inc.; 2011.
  7. Kanji S, MacLean RD. Cardiac glycoside toxicity: more than 200 years and counting. Crit Care Clin. 2012(4);28:527-535.
  8. Gona SR, Rosenberg J, Fyffe-Freil RC, Kozakiewicz JM, Money ME. Review: Failure of current digoxin monitoring for toxicity: new monitoring recommendations to maintain therapeutic levels for efficacy. Front Cardiovasc Med. 2023;10:1179892.
  9. Bala M, Catena F, Kashuk J, et al. Acute mesenteric ischemia: updated guidelines of the World Society of Emergency Surgery. World J Emerg Surg. 2022;17(1):54.

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.