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

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FAQs

Frequently Asked Questions
About DIGIFab

Does the infusion rate and total infusion time for DIGIFab® differ depending on the dose administered?

The summary of product characteristics for DIGIFab® states “The final solution of reconstituted and diluted DIGIFab® should be infused intravenously over a 30 minute period. As with any intravenous protein product, infusion-related reactions or hypersensitivity reactions are possible. It is recommended that patients are monitored for signs and symptoms of anaphylaxis and an acute allergic reaction. Medical support must be readily available when DIGIFab® is administered. If an anaphylactic reaction occurs during an infusion then administration of DIGIFab® must be stopped immediately.” The infusion rate and duration recommendations in the summary of product characteristics relate to the entire dose, regardless of how many vials are administered.1

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Is the dosing of DIGIFab® different between adults and children?

The method of determining the dose of DIGIFab® is the same for adults and children >20kg, and is based on the serum concentration of digoxin (or amount of digoxin ingested). However, the method for determining dose for children <20kg differs from that of adults and children >20kg. In children <20 kg the dose is based on if serum digoxin concentration is known or not known.1

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Is there latex in DIGIFab® or in the DIGIFab® vial stopper?

DIGIFab® does not contain latex. However, the likelihood of an allergic reaction may be higher in subjects who are allergic to papain, an extract of the papaya fruit. Papain is used to cleave the whole antibody into Fab and Fc fragments: traces of papain or inactivated papain residues may be present in DIGIFab®. Papain shares allergenic structures with (i) chymopapain and other papaya extracts, (ii) bromelain found in pineapple, (iii) dust mite allergens, and (iv) latex allergens.1

Can DIGIFab® be readministered?

If, after several hours, toxicity has not adequately reversed or appears to recur, readministration of DIGIFab® at a dose guided by clinical judgement may be required. Failure of the patient to respond to DIGIFab® should alert the physician to the possibility that the clinical problem may not be due to digoxin toxicity.1

Is there a generic version of DIGIFab®?

No, there is no generic version of DIGIFab® available.

Is DIGIFab® the same as Digibind® (digoxin immune fab)?

No, DIGIFab® is not the same product as Digibind but has demonstrated comparable in vivo binding affinity for digoxin. In a comparative pharmacokinetic study of DIGIFab® and Digibind® administered in healthy volunteers, both meditations rapidly reduced serum free digoxin to undetectable levels within 30 minutes, and serum digoxin levels were reduced to undetectable levels in all subjects.2

Are there other causes of cardiac glycoside toxicity?

In addition to digoxin, other cardiac glycosides exist and have been associated with toxicity or poisoning, including the xenobiotics ouabain and lanatoside C; various plants, including foxglove, dogbane, red squill, lily of the valley, oleander, and henbane; and bufadienolides, cardioactive steroids found in the skin of toads belonging to the family Bufonidae.3 DIGIFab® is not indicated to treat these other forms of cardiac glycoside toxicity.1

Have more questions? Contact us.

Contact our 24-hour Medical Information line at +1 303-389-1204 or email BTGPharmaMedicalInfo@btgsp.com.

References

  1. DIGIFab Digoxin Immune Fab (ovine) [summary of product characteristics]. Protherics UK Limited; 2017.
  2. 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.
  3. Levine MD, O’Connor A. Digitalis (cardiac glycoside) poisoning. UpToDate. Updated January 2020. https://www.uptodate.com/contents/digitalis-cardiac-glycoside-poisoning. Accessed December 2023. 
  4. 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.