No

Antidote

Digoxin immune antigen-binding fragments (Fab) are specific antibodies for the treatment of digitalis intoxication in carefully selected patients; used in life-threatening ventricular arrhythmias secondary to digoxin, acute digoxin ingestion (ie, >10 mg in adults or >4 mg in children), hyperkalemia (serum potassium >5 mEq/L) in the setting of digoxin toxicity

C

Hypersensitivity to sheep products; severe renal dysfunction; anuria

Suicidal attempts often involve multiple drugs. Consider other drug toxicities as well. Hypersensitivity reactions can occur. Epinephrine should be immediately available. Serum potassium levels should be monitored, especially during the first few hours after administration. Total serum digoxin concentrations will rise precipitously following administration of this drug (has no clinical meaning - avoid monitoring serum concentrations). If digoxin was being used to treat CHF then may see exacerbation of symptoms as digoxin level is reduced. Use with caution in renal failure (experience limited) - the complex will be removed from the body more slowly. Monitor for reoccurrence of digoxin toxicity. Has reversed thrombocytopenia induced by digoxin.

<1% (Limited to important or life-threatening symptoms): Worsening of low cardiac output or congestive heart failure, rapid ventricular response in patients with atrial fibrillation as digoxin is withdrawn, facial edema and redness, hypokalemia

Symptoms of overdose include delayed serum sickness

Treatment of serum sickness includes acetaminophen, histamine₁ and possibly histamine₂ blockers and corticosteroids

potassium; digoxin levels

Should be refrigerated (2°C to 8°C); reconstituted solutions should be used within 4 hours if refrigerated

Binds with molecules of digoxin or digitoxin and then is excreted by the kidneys and removed from the body

Onset of action: I.V.: Improvement in signs and symptoms occur within 2-30 minutes

Half-life: 15-20 hours; prolonged in patients with renal impairment

Elimination: Renally with levels declining to undetectable amounts within 5-7 days

Each vial of Digibind® 40 mg will bind ~0.6 mg of digoxin or digitoxin.

Fab dose based on number of tablets (0.25 mg) ingested:

5 tablets ingested: Fab dose 68 mg (1.7 vials)

10 tablets ingested: Fab dose 136 mg (3.4 vials)

25 tablets ingested: Fab dose 340 mg (8.5 vials)

50 tablets ingested: Fab dose 680 mg (17 vials)

75 tablets ingested: Fab dose 1000 mg (25 vials)

100 tablets ingested: Fab dose 1360 mg (34 vials)

150 tablets ingested: Fab dose 2000 mg (50 vials)

Fab dose based on serum drug level postdistribution:

Digoxin: No. of vials = level (ng/mL) x body weight (kg) divided by 100

Digitoxin: No. of vials = digitoxin (ng/mL) x body weight (kg) divided by 1000

If neither amount ingested nor drug level are known, dose empirically with 10 and 5 vials for acute and chronic toxicity, respectively

Serum potassium, serum digoxin concentration prior to first dose of digoxin immune Fab; digoxin levels will greatly increase with Digibind® use and are not an accurate determination of body stores

No information available to require special precautions

No effects or complications reported

Patient education and instruction will be determined by patient condition and ability to understand. Immediately report dizziness, palpitations, cramping, or difficulty breathing. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Parenteral: Digoxin immune Fab is reconstituted by adding 4 mL sterile water, resulting in 10 mg/mL for I.V. infusion, the reconstituted solution may be further diluted with NS to a convenient volume (eg, 1 mg/mL); infuse over 15-30 minutes; to remove protein aggregates, 0.22 micron in-line filter is needed

Powder for injection, lyophilized: 38 mg

Antman EM, Wenger TL, Butler VP Jr, et al, "Treatment of 150 Cases of Life-Threatening Digitalis Intoxication With Digoxin-Specific Fab Antibody Fragments," Circulation, 1990, 81(6):1744-52.

Aruna AS and Jue SG, "Digoxin Immune Fab Administration Following an Unexplained Increase in Serum Digoxin Concentration," J Pharm Sci Technol, 1994, 10:246-9.

Hickey AR, Wenger TL, Carpenter VP, et al, "Digoxin Immune Fab Therapy in the Management of Digitalis Intoxication: Safety and Efficacy Results of an Observational Surveillance Study," J Am Coll Cardiol, 1991, 17(3):590-8.

Kaufman J, Leikin J, Kendzierski D, et al, "Use of Digoxin Fab Immune Fragments in a Seven-Day-Old Infant," Pediatr Emerg Care, 1990, 6(2):118-21.

Leikin J, Vogel S, Graft J, et al, "Use of Fab Fragments of Digoxin-Specific Antibodies in the Therapy of Massive Digoxin Poisoning," Ann Emerg Med, 1985, 14(2):175-8.

Martiny SS, Phelps SJ, and Massey KL, "Treatment of Severe Digitalis Intoxication With Digoxin-Specific Antibody Fragments, A Clinical Review," Crit Care Med, 1988, 16(6):629-35.

Shumaik GM, Wu AW, and Ping AC, "Oleander Poisoning: Treatment With Digoxin-Specific Fab Antibody Fragments," Ann Emerg Med, 1988, 17(7):732-5.

Ujhelyi MR and Robert S, "Pharmacokinetic Aspects of Digoxin-Specific Fab Therapy in the Management of Digitalis Toxicity," Clin Pharmacokinet, 1995, 28(6):483-93.

Varriale P and Mossavi A, "Rapid Reversal of Digitalis Delirium Using Digoxin Immune Fab Therapy," Clin Cardiol, 1995, 18(6):351-2.