Prescribing Information Summary of Product Characteristics
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Dosing

Appropriate Dosing Neutralises Digoxin and other Cardiac Glycosides1,2


  • DIGIFab® dosing varies depending on whether plasma digoxin concentration is available.
  • Each vial of DIGIFab® contains 40 mg of digoxin immune Fab (ovine) protein.

It is advised to discuss management of patients with digoxin toxicity or cardiac glycoside poisoning with TOXBASE (UK National Poisons Information Service) at the following contact phone number: +44 344 892 0111 (in Ireland NPIC (01) 809 2566) and/or refer to the most up to date TOXBASE guidance at https://www.toxbase.org/.

Reconstitute prior to administration and infuse intravenously over a 30-minute period.

Summary of Dosing Guidelines

For poisoning from pharmaceutical digoxin

A. Cardiac arrest due to digoxin toxicity:

Urgently administer digoxin-specific FAB fragments as an IV bolus, further doses may be required if an adequate clinical response is not seen after 30 minutes:

Weight
(adult and chidren)		 DIGIFab dose
(each vial should be reconstituted with 4 mL of sterile water by gentle mixing)
>40 Kg 5 vials (200 mg)
20–40 Kg 2 vials (80 mg)
≤20 Kg 1 vial (40 mg)

B. Severe bradyarrhythmia or life-threatening ventricular arrhythmia.

OR

C. Severe hyperkalaemia (e.g. K+ greater than 6.5 mmol/L) resistant to adequate rehydration and conventional treatments.

NOTE: this applies to acute digoxin overdose on top of usual therapy, acute overdose in digoxin-naive patient and digoxin toxicity from chronic therapy.

1. When digoxin concentration is available (measured 6 hours after overdose, unless urgently indicated in patient with arrhythmia).
Number of vials = (serum digoxin concentration (ng/mL) X weight (kg)) ÷ 200

Round up to the nearest vial. Each vial should be reconstituted with 4 mL of sterile water by gentle mixing.


2. When only ingested dose is available:
Number of vials = Amount of digoxin ingested (mg) X 0.8

Round up to the nearest vial. Each vial should be reconstituted with 4 mL of sterile water by gentle mixing.

Digoxin concentrations in mmol/L should be converted to ng/mL (same as μg/L) for the estimations above by using the formula:
[Digoxin] nmol/L x 0.781 = [Digoxin] ng/mL

For poisoning from cardiac glycosides other than pharmaceutical digoxin

A. Cardiac arrest due to cardiac glycosides other than digoxin:

Urgently administer digoxin-specific FAB fragments as an IV bolus; further doses may be required if an adequate clinical response is not seen after 30 minutes:

Weight
(adult and chidren)		 DIGIFab dose
(each vial should be reconstituted with 4 mL of sterile water by gentle mixing)
>40 Kg 5 vials (200 mg)
20–40 Kg 2 vials (80 mg)
≤20 Kg 1 vial (40 mg)

B. Severe bradyarrhythmia or life-threatening ventricular arrhythmia

OR

C. Severe hyperkalaemia (e.g. K+ greater than 6.5 mmol/L) resistant to adequate rehydration and conventional treatments:

Urgently administer digoxin-specific antibody FAB fragments as an IV bolus; repeat doses after 15 – 30 minutes if response is inadequate:

Weight
(adult and children)		 DIGIFab dose
(each vial should be reconstituted with 4 mL of sterile water by gentle mixing)
>40 Kg 2 vials (80 mg)
≤40 Kg 1 vial (40 mg)
  • 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 (SmPC).
  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 2024.
  3. 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.