Prescribing Information Summary of Product Characteristics
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Dosing

Appropriate Dosing Neutralises Digoxin1,2


  • DIGIFab® dosing varies according to the patient’s clinical condition and the amount of
    digoxin to be neutralised.
  • Each vial of DIGIFab® contains 40 mg of digoxin immune Fab (ovine) protein.



Use the DIGIFab® dose calculator.


  • Calculations suitable for adults and children >20kg

Acute Toxicity*

Calculate full neutralisation dose by entering the amount of digoxin ingested or serum digoxin concentration (if the amount of digoxin ingested is not known)

Amount of digoxin ingested x 1.6

OR

Serum digoxin
concentration x weight /100

DIGIFab®
Dose

  • # vials†
  • # mg
  • Half the estimated dose required for full neutralisation can be given initially followed by monitoring for 6-12 hours if there is a full response. The remainder may be given if there is no clinical response within 2 hours.
  • In acute digoxin toxicity, the serum digoxin concentration does not reflect total body load and complete neutralisation is not necessary in digoxin-naïve patients.
  • In children <20kg, if serum digoxin concentration is known use the serum digoxin concentration calculator above. If serum digoxin concentration in not known, one vial of DIGIFAB® will usually be sufficient for full neutralisation.

Rounded up to the nearest vial.

Acute-on-Chronic Toxicity*

Calculate full neutralisation dose by entering the amount of digoxin ingested or serum digoxin concentration (if the amount of digoxin ingested is not known)

Amount of digoxin ingested x 1.6

OR

Serum digoxin
concentration x weight /100

DIGIFab®
Dose

  • # vials†
  • # mg
  • A full neutralisation dose can be given if the amount of digoxin is known.
  • If the amount of digoxin is not known, then a half-neutralising dose based on serum digoxin concentration should be used followed by monitoring for 6-12 hours if there is a full response. The remainder may be given if there is no clinical response within 2 hours.
  • In children <20kg, if serum digoxin concentration is known use the serum digoxin concentration calculator above. If serum digoxin concentration in not known, one vial of DIGIFAB® will usually be sufficient for full neutralisation.

Rounded up to the nearest vial.

Chronic Toxicity

Calculate full neutralisation dose by entering serum digoxin concentration

Serum digoxin
concentration x total weight /100

DIGIFab®
Dose

  • # vials†
  • # mg
  • Half the estimated dose required for full neutralisation can be given initially followed by monitoring for 6-12 hours. The remainder may be given if there is recurrence of toxicity.
  • In chronic digoxin toxicity, the dose of DIGIFab® required for full neutralisation depends on the total body load of cardiac glycoside which has to be counteracted. However, as these patients are receiving digoxin therapeutically, full neutralisation is not necessary.
  • In children <20kg, if serum digoxin concentration is known use the serum digoxin concentration calculator above. If serum digoxin concentration in not known, one vial of DIGIFAB® will usually be sufficient for full neutralisation.

Rounded up to the nearest vial.

*Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked.

  • From a microbiological point of view, the product should be used immediately after reconstitution.1
  • Store between 2° and 8°C.1
  • Do not freeze.1
  • Keep vial in outer carton in order to protect from light.1


For complete dosing information, please see Summary of Product Characteristics.

References

  1. DIGIFab Digoxin Immune Fab (ovine) [summary of product characteristics]. Protherics UK Limited; 2017.
  2. Levine MD, O’Connor A. Dosing regimen for digoxin-specific antibody (Fab) fragments in patient with digoxin toxicity. UpToDate. Updated December 2021. https://www.uptodate.com/contents/dosing-regimen-for-digoxin-specific-antibody-fab-fragments-in-patients-with-digoxin-toxicity. Accessed December 2023.
  3. 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.