DigiFab® Digoxin Immune Fab (Ovine) is a sterile, purified, lyophilized preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments.1
Each vial of DigiFab® Digoxin Immune Fab (Ovine), which will bind approximately 0.5 mg digoxin, contains 40 mg of digoxin immune Fab, 75 mg (approx) of mannitol USP, and 2 mg (approx) sodium acetate USP as a buffering agent.1
The product contains no preservatives and is intended for intravenous administration after reconstitution with 4 mL of Sterile Water for Injection USP.1
DigiFab® Digoxin Immune Fab (Ovine)1:
- Rapidly binds to and neutralizes digoxin with measurable results
- Rapidly reduces levels of free digoxin to undetectable
- More than 40% of digoxin excreted by 24 hours
- 93% of patients resolved their digoxin poisoning by 20 hours
- Has a well-established safety profile
- 10 years' experience in managing digoxin toxicity
- Offers flexible dosing, specific to the clinical situation
To report an adverse event or for 24-hour medical information, call 1-844-293-0007.References
- DigiFab® [prescribing information]. BTG International Inc. January 2012.
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.