Description
Description
Active ingredient: Digoxin Immune Fab (Ovine)
DigiFab®, 40 mg/vial, Powder for solution for infusion
Each 1 vial contains 40 mg Digoxin Immune Fab (Ovine)
DIGIFAB is the brand innovator for Digoxin Immune Fab (Ovine) – FDA approved
Indications:
DIGIFAB is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including:
- Known suicidal or accidental consumption of fatal doses of digoxin: 10 mg or more of digoxin in healthy adults, or 4 mg (or more than 0.1 mg/kg) in healthy children, or ingestion of an amount that can cause steady state serum concentrations of ≥10 ng/mL;
- Chronic ingestions causing steady-state serum digoxin concentrations >6 ng/mL in adults or 4 ng/mL in children;
- Manifestations of life-threatening toxicity of digoxin overdose such as severe ventricular arrhythmias, progressive bradycardia, and second- or third-degree heart block not responsive to atropine, serum potassium levels exceeding 5.5 mEq/L in adults or 6 mEq/L in children with rapidly progressive signs and symptoms of digoxin toxicity.
Dosage and route of administration
Dosage
General Guidelines:
Adjust the dosage of DIGIFAB according to the amount of digoxin to be neutralized.
Failure of the patient to respond to DIGIFAB should alert the physician to the possibility that the clinical problem may not be caused by digitalis toxicity.
Method of administration
By Intravenous Injection Only