You are viewing content for the region United States

Certain BTG products may not be available within the chosen location and indications may differ from your country's approved use.

Change to Canada »
Remain viewing United States »

This website is intended for US Healthcare Professionals only

DigiFab FAQs

DigiFab® Digoxin Immune Fab (Ovine) is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. BTG International does not recommend the use of DigiFab® that is in any way inconsistent with its prescribing information.1

Please click on a question below to see a relevant answer.

  • Q1 Does the infusion rate and total infusion time for DigiFab® differ depending on the dose administered?
    A.

    The package insert for DigiFab® states that "DigiFab® should be administered slowly as an intravenous infusion over at least 30 minutes. If infusion rate-related reactions occur, the infusion should be stopped and re-started at a slower rate. If cardiac arrest is imminent, DigiFab® can be given by bolus injection. With bolus injection, an increased incidence of infusion-related reactions may be expected." The infusion rate and duration recommendations in the package insert relate to the entire dose, regardless of how many vials are administered.1

  • Q2 Is the dosing of DigiFab® different between adults and children?
    A.

    The method of determining the dose of DigiFab® is the same for adults and children and is based on the total body burden of digoxin, which is calculated from the patient's weight and steady state serum concentration of digoxin. For infants and small children who may require very small doses, it is recommended that the 40 mg vial be reconstituted as directed and administered undiluted using a tuberculin syringe. For toxicity during chronic digoxin therapy, and an unknown serum digoxin concentration, 6 vials of DigiFab® is recommended for adults, while for infants and small children (< 20kg) the recommended dose is 1 vial.1

  • Q3 Is there latex in DigiFab®?
    A.

    DigiFab® does not contain latex. However, papain is used to manufacture DigiFab®, and trace amounts of papain may be present in the product. While papain allergy is not a contraindication to the use of DigiFab®, it has been noted in the literature that latex and dust mite allergens share antigenic structures with papain and patients with allergies to latex or dust mites may also be allergic to papain and have the potential to have an allergic reaction to DigiFab®. If a patient has a known life-threatening hypersensitivity reaction to latex, the risk-benefit of administration should be evaluated.1

  • Q4 Is there latex in the DigiFab® vial stopper?
    A.

    DigiFab® does not contain latex, and the vial stopper is made out of synthetic rubber which does not contain latex. However, papain is used to manufacture DigiFab®, and trace amounts of papain may be present in the product. While papain allergy is not a contraindication to the use of DigiFab®, it has been noted in the literature that latex and dust mite allergens share antigenic structures with papain and patients with allergies to latex or dust mites may also be allergic to papain and have the potential to have an allergic reaction to DigiFab®. If a patient has a known life-threatening hypersensitivity reaction to latex, the risk-benefit of administration should be evaluated.1

  • Q5 Should skin testing be performed prior to administering DigiFab®?
    A.

    Skin testing was not performed in the clinical trials of DigiFab®, is not a recommendation within the DigiFab® package insert, and is not required before its administration.1

  • Q6 What do I do if my question has not been sufficiently answered?
    A.

    Please call our 24-hour Medical Information line at 1-877-377-3784.

References

  1. DigiFab® [prescribing information]. BTG International Inc. January 2012.
  2. Centers for Medicare and Medicaid Services. Healthcare Common Procedure Coding System: Overview. http://www.cms.gov/MedHCPCSGenInfo/. Updated May 23, 2018. Accessed August 20, 2018.

To report an adverse event or for 24-hour medical information, call 1-877-377-3784