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

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An Antidote for Digoxin Toxicity

DIGIFab® is an Antidote for Digoxin Toxicity1-7

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

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Acronyms

MHRA, Medicines and Healthcare products Regulatory Agency; 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

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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]. Protherics UK Limited; 2017. 
  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. Available at: https://rcem.ac.uk/clinical-guidelines/ Accessed December 2023.
  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 2023.
  9. Levine MD, O’Connor A. UpToDate. Updated January 2020. Available at: https://www.uptodate.com/contents/digitalis-cardiac-glycoside-poisoning. Accessed December 2023.