Ovine digoxin immune fab

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.

DIGIFAB has an affinity for digoxin in the range of 10 9 to 10 10 M -1, which is greater than the affinity of digoxin for its sodium pump receptor, the presumed receptor for its therapeutic and toxic effects. When administered to the intoxicated patient, DIGIFAB binds to molecules of digoxin reducing free digoxin levels, which results in a shift in the equilibrium away from binding to the receptors, thereby reducing cardio-toxic effects. Fab-digoxin complexes are then cleared by the kidney and reticuloendothelial system.

For Intravenous Use Only For intravenous use only Clinical Conditions Dosage Acute ingestion of unknown amounts of digoxin and toxicity in the absence of a serum digitalis concentration or estimated ingestion amount Administer 20 vials of DIGIFAB. Monitor for volume overload in small (< 20 Kg) children. Start with 10 vials followed by an additional 10 vials, if needed, to avoid a febrile reaction. Chronic digoxin toxicity in the absence of a serum digitalis concentration Administer 6 vials of DIGIFAB in Adults and Children ≥ 20 Kg. Administer 1 vial of DIGIFAB in Infants and Children < 20 Kg. Acute ingestion of known amounts of digoxin Dose (in vials) = Amount of digoxin ingested (in mg) 0.5 mg/vial Chronic digoxin toxicity and known serum digitalis concentration Dose (in vials) = (Serum digoxin ng/mL)(weight in kg) 100

There are no known contraindications to the use of DIGIFAB.

Rapid drop in serum potassium concentration after treatment with DIGIFAB. Monitor frequently, especially after the first several hours of DigiFab administration. Anaphylaxis and hypersensitivity reactions are possible. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may be at risk for an allergic reaction to DIGIFAB. Clinically misleading reading of standard serum digoxin concentration may occur after administration of DIGIFABdue to interference with digitalis immunoassay measurements.

The most common adverse reactions (> 7%) related to DIGIFAB administration are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). The most common adverse reactions (>7%) are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%).

Store at 2 ° to 8 ° C (36 ° to 46 ° F). Do not freeze.