Infant Data
Results
FDA APPROVED INDICATION
Digoxin immune Fab is indicated for life-threatening or potentially life-threatening digoxin toxicity or overdose in children, including the following situations: ingestion of fatal doses of 4 mg (or 0.1 mg/kg) or more, or amounts leading to serum concentrations of 10 ng/mL or greater; chronic ingestions leading to levels greater than 4 ng/mL; and in the presence of severe ventricular arrhythmias, bradycardia, second/third degree heart block that is unresponsive to atropine, or potassium levels greater than 6 mEq/L with rapidly progressive signs of toxicity. ECG abnormalities and hyperkalemia typically resolve within 4 hours after digoxin immune Fab administration.
CONTRAINDICATIONS/PRECAUTIONS
Anaphylaxis and hypersensitivity reactions may occur; higher risk in patients with sheep protein allergies or who have previously received intact ovine antibodies or ovine Fab. Patients with poor cardiac function may deteriorate upon loss of inotropic effect of digoxin. Hypokalemia may occur; monitoring recommended.
ADVERSE EFFECTS
The most common adverse reactions are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%).
ADMINISTRATION
Reconstitute the vial (40 mg) with 4 mL of Sterile Water for Injection and mix gently; the final concentration will be approximately 10 mg/mL (see Special Considerations section for storage and stability of the reconstituted vial). May dilute the reconstituted solution to an appropriate volume of NS for administration. Very small doses (less than 1 mL) may be given undiluted via a tuberculin syringe or the reconstituted solution may be further diluted with 36 mL of NS to achieve a 1 mg/mL concentration. Administer by slow IV infusion over 30 minutes; if cardiac arrest is imminent, the solution can be given by bolus injection. Stop temporarily the IV infusion for any infusion-rate related anaphylactoid reactions (eg, hypotension, wheezing, urticaria) and restart at a lower rate. Incidence of infusion-related reactions may be increased with bolus injection.
MONITORING
Monitor serum digoxin serum concentration before digoxin immune Fab administration, if possible, to establish the digitalis intoxication diagnosis. Serum digoxin concentrations may be inaccurate for a period of time (several days or a week, or more in patients with renal impairment) after administration due to interference with digitalis immunoassay measurements. Monitor temperature, blood pressure, and ECG during and after administration. Monitor potassium levels frequently, particularly during the first several hours after administration. Consider assessing free digoxin levels after administration in patients with renal failure to detect a possible recurrence of toxicity. Monitor for signs and symptoms of hypersensitivity reactions.