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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.

What are the reimbursement codes for DigiFab®?

A.

The reimbursement codes for DigiFab® may be found here. Click on the reimbursement link to find information related to possible ICD-9-CM, CPT, DRG and Revenue codes. The HCPCS Level 2 code for DigiFab® is J1162. The NDC# is 50633-120-11. These codes are not intended to be a complete listing of all possible codes and do not imply that reimbursement will be granted as specific benefit coverage will vary based on payor and provider contract.2

Q6.

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

Q7.

What do I do if my question has not been sufficiently answered?

A.

Please complete and submit our Medical Inquiry Form

To report an adverse event or for 24-hour medical information, call 1-844-293-0007.

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 January 20, 2011. Accessed March 24, 2011.

Indication
DigiFab® Digoxin Immune Fab (Ovine) is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. DigiFab® is not indicated for milder cases of digitalis toxicity.

Important Safety Information
Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab®.  Rapid drop in serum potassium concentration may occur after treatment with DigiFab®. Patients with known allergies to sheep protein, papaya, or papain are at higher risk of an anaphylactic reaction. Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked. The most common adverse reactions (>7%) related to DigiFab® are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). Please see full prescribing information, including events, precautions, or warnings.