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

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An Antidote for Digoxin Toxicity and Cardiac Glycoside Poisoning

DIGIFab® is an Antidote for Digoxin Toxicity and Cardiac Glycoside Poisoning1-7

A proven antidote for digoxin toxicity with over 20 years of clinical experience1-7

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Acronyms

NPIS, National Poisons Information Service; RCEM, Royal College of Emergency Medicine; RCT, randomised controlled trial; FDA, US Food and Drug Administration. 

Potential Life-Saving Power of DIGIFab® 5,7,9

digoxin-toxicity-digifab-rapid-resolution-image

Rapid Resolution

DIGIFab® reduced free digoxin to
undetectable levels within 30 minutes
in 100% of individuals.*5

See How DIGIFab® Works
digoxin-immune-fab-digifab-clinically-proven-image

Proven Results

DIGIFab® rapidly neutralises free digoxin to resolve
the cardiotoxic effects and other clinical manifestations
of life-threatening digoxin toxicity.3,5

View Efficacy Data

*Study was conducted in healthy participants (n = 8)  

References

  1. 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.
  2. Data on file. BTG International Ltd.
  3. Hack JM, Lewin NA. Cardioactive Steroids. Goldfrank’s Toxicologic Emergencies, 8th edition; 2019. 971-982.
  4. Schaeffer TH, Mlynarchek SL, Stanford CF, Delgado J, Holstege CP, Olsen D, Bogdan GM. Treatment of chronically digoxin-poisoned patients with a newer digoxin immune fab--a retrospective study. J Am Osteopath Assoc. 2010 Oct;110(10):587-92.
  5. DIGIFab Digoxin Immune Fab (ovine) Summary of Product Characteristics (SmPC).
  6. 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.
  7. 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.
  8. Vaccines, Blood & Biologics. August 31, 2001 Approval Letter - DigiFab. Available at: https://wayback.archive-it.org/7993/20170722071615/https:/www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089336.htm Accessed December 2024.
  9. Levine MD, O’Connor A. UpToDate. Updated January 2020. Available at: https://www.uptodate.com/contents/digitalis-cardiac-glycoside-poisoning. Accessed December 2024.