Prescribing Information Summary of Product Characteristics
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Early Recognition

Early Recognition of Digoxin Toxicity Is Essential

  • Early recognition of life-threatening digoxin toxicity may result in improved treatment outcomes.1,2
  • Signs of life-threatening digoxin toxicity include life-threatening or haemodynamically unstable cardiac dysrhythmias, hypokalaemia, 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 life-threatening digoxin toxicity

Signs of digoxin toxicity include:

Chronic

digoxin toxicity signs cardiac arrhythmias image

Cardiac Dysrhythmias3,4

  • Severe ventricular dysrhythmias3,4 (e.g. ventricular tachycardia, ventricular fibrillation)
  • Progressive bradydysrhythmias3,4 (e.g. severe sinus bradycardia, second or third-degree heart block unresponsive to atropine)
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Laboratory Parameters2,5

  • Severely elevated serum potassium levels with rapidly progressive signs and symptoms2,5 (e.g. > 5.5 mEq/L in adults or 6>mEq/L in neonates)
  • Severely elevated serum digoxin levels with clinically significant signs and symptoms2,5 (e.g. steady state concentrations >6 ng/mL in adults or >4 ng/mL in children)6
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digoxin toxicity signs end organ dysfunction image

Evidence of End-Organ Dysfunction2,5

  • Signs and symptoms of end-organ dysfunction from hypoperfusion2 (e.g. renal failure, altered mental status, abnominal pain)
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Acute

digoxin toxicity signs cardiac arrhythmias image

Cardiac Dysrhythmias2,3,6,7

  • Sinus bradycardia, second or third degree AV block
  • Any type of dysrhythmias possible
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Laboratory Parameters2,5-7

  • Severely elevated serum potassium levels with rapidly progressive signs and symptoms2,5-7 (e.g. >5.5 mEq/L in adults or 6> mEq/L in children)
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digoxin toxicity signs end organ dysfunction image

Gastrointestinal symptom2,7

  • Nausea, vomiting, abdominal pain
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neurological symptoms image

Neurological symptoms2,7

  • Weakness, confusion, lethargy
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Any ONE may indicate the need for
IMMEDIATE INTERVENTION2,3

When to Deliver DIGIFab®
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For known (or strongly suspected) life-threatening digoxin toxicity or cardiac glycoside poisoning, think R.A.P.I.D.1-3

Recognize. Act. Promptly Infuse DIGIFab®.

View Efficacy Data

* DIGIFab® is indicated for the treatment of known (or strongly suspected) life-threatening digoxin toxicity or cardiac glycoside poisoning associated with ventricular arrhythmias or bradyarrhythmias unresponsive to atropine where measures beyond withdrawal of digoxin or cardiac glycosides and correction of serum electrolyte abnormalities are considered necessary.4

References

  1. Royal College of Emergency Medicines and National Poisons Information Service Guideline on Antidote Availability for Emergency Departments. Guideline available from RCEM, at: https://rcem.ac.uk/clinical-guidelines/ Accessed December 2024.
  2. Levine MD, O’Connor A. Digitalis (cardiac glycoside) poisoning. UpToDate. Updated January 2020. https://www.uptodate.com/contents/digitalis-cardiac-glycoside-poisoning. Accessed December 2024.
  3. DIGIFab Digoxin Immune Fab (ovine) Summary of Product Characteristics (SmPC).
  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 December 2024.
  5. Data on File. BTG International Ltd.
  6. Hassan SA, Goyal A. Digoxin Immune Fab. Available at: https://www.ncbi.nlm.nih.gov/books/NBK556101/. Published 2021.  Accessed December 2024.
  7. Hack JM, Lewin NA. Cardioactive Steroids. Goldfrank’s Toxicologic Emergencies. 2019: 971-982.