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Digifab: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
40 mg
Active ingredient:

Patient Medication Information: uses, side effects, how to take - Digifab

What is DigiFab used for?

  • DigiFab®, Digoxin Immune Fab (Ovine) is used in the treatment of life-threatening toxicity caused by digoxin

How does DigiFab work?

DigiFab® is made up of antibody fragments that will bind specifically to the digoxin in your body. By binding to the digoxin, DigiFab® will counteract the effect of the digoxin and assist in its removal from your body.

What are the ingredients in DigiFab?

Medicinal ingredients: Digoxin-specific antibody fragments (Fab)

Non-medicinal ingredients: Mannitol and Sodium acetate

DigiFab comes in the following dosage forms:

Sterile, freeze dried powder.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DigiFab. Talk about any health conditions or problems you may have, including if you:

  • You have any allergies to this drug or its ingredients.
  • You have allergies to antibiotics.
  • You have a history of asthma.
  • You have an allergy to papain, chymopapain, or other papaya extracts or to pineapples (an enzyme called bromelain).
  • You have an allergy to alpha-gal or have been diagnosed with alpha-gal syndrome (a type of food allergy to red meat and other products made from mammals).
  • You have a history of tick bites.
  • You have an allergy to latex.
  • You have kidney disease.
  • You are taking digoxin for heart problems.
  • You are pregnant or breastfeeding.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with DigiFab:

There are no known interactions between DigiFab® and food or herbal products.

How to take DigiFab:

  • DigiFab will be given to you by a healthcare professional in a healthcare setting

Usual dose:

The dosage of DigiFab® varies according to the amount of digoxin in your body. The average dose used during clinical testing was 4 vials, but the dose can vary between 1 and 20 vials, depending on how much digoxin is in your body.

Your doctor or pharmacist will calculate the dose of DigiFab® you need. Sterile water will be added to the vials to dissolve the powder, and then the contents of the vials will be added to a bag of saline. The contents of the bag will be given to you by an infusion (through a needle in a vein). In some cases, if necessary, the total dose will be directly injected into a vein using a syringe.

Overdose:

If you think you, or a person you are caring for, have taken too much DigiFab, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using DigiFab

These are not all the possible side effects you may have when taking DigiFab If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, DigiFab® can cause side effects, although not everyone gets them. The following side effects may occur and you should tell your doctor or nurse immediately if you experience them:

  1. 1. Allergic reactions including rash with or without itching
  2. 2. Shaking, chills, or fever
  3. 3. Swelling of the throat, tongue or face
  4. 4. Difficulty breathing
  5. 5. Pain or redness at the infusion site
  6. 6. Worsening congestive heart failure (shortness of breath or swelling in arms or legs)

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

You will be given DigiFab® in the hospital. The hospital will store the medication correctly, in the refrigerator at a temperature between 2 and 8 °C.

Once the vials of DigiFab® have been reconstituted (water added to make a solution), it should be used immediately, and at least within 4 hours.

Keep out of reach and sight of children.

If you want more information about DigiFab:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.digifab.health, or by calling 1-844-233-7167.

Last Revised November 25, 2022

Digibind® is a registered trademark of Glaxo Group Limited.

DigiFab® is a registered trademark of BTG International Inc.

BTG and the BTG roundel logo are registered trademarks of BTG International Ltd in the US, EU and certain other territories, and are trademarks of BTG International Ltd elsewhere.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02361043

Revision date stated in the text: November 25, 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Digifab

Rx or OTC
Prescription (Rx)?
DIN 02361043
Schedule(s) SCHEDULE D; PRESCRIPTION
Active ingredient(s) Digoxin immune fab (ovine) 40 MG
Dosage form(s) Powder For Solution
Route(s) of administration Intravenous
Drug class (WHO ATC)
  1. V Various drug classes
    1. V03 All other therapeutic products
      1. V03A All other therapeutic products
        1. V03AB Antidotes
          1. V03AB24 Digitalis antitoxin
Company BTG INTERNATIONAL INC
Current status Marketed
Current status date November 4, 2011

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.