digoxin immune Fab(di-jox-in im-myoon fab) ,
Pregnancy Category: C
Pharmacologic: antibody fragments
Pharmacologic: antibody fragments
Serious life-threatening overdosage with digoxin.
An antibody produced in sheep that binds antigenically to unbound digoxin in serum.
Binding and subsequent removal of digoxin, preventing toxic effects in overdose.
Absorption: Administered IV only, resulting in complete bioavailability.
Distribution: Widely distributed throughout extracellular space.
Metabolism and Excretion: Excreted by the kidneys as the bound complex (digoxin immune Fab plus digoxin).
Half-life: 14–20 hr.
Time/action profile (reversal of arrhythmias and hyperkalemia; reversal of inotropic effect may take several hr)
|IV||30 min (variable)||unknown||2–6 hr|
Contraindicated in: No known contraindications.
Use Cautiously in: Known hypersensitivity to sheep proteins or products;Children, pregnancy, or lactation (safety not established).
Adverse Reactions/Side Effects
- re-emergence of atrial fibrillation
- re-emergence of HF
Fluid and Electrolyte
- hypokalemia (life-threatening)
Drug-Drug interactionPrevents therapeutic response to digoxin.
Route/DosageDigibind—38 mg of digoxin immune Fab will bind 0.5 mg of digoxin. Each vial contains 38 mg of digoxin immune Fab; DigiFab—40 mg of digoxin immune Fab will bind 0.5 mg of digoxin. Each vial contains 40 mg of digoxin immune Fab
Known Amount of Digoxin Ingested (Administered)
Intravenous (Adults and Children) For digitalis glycoside toxicity due to digoxin tablets, oral solution, or IM digoxin—dose of digoxin ingested (mg) × 0.8/1000 × 38. For digitalis glycoside toxicity due to digoxin capsules, IV digoxin—dose of digoxin ingested (mg)/0.5 × 38.
Known Serum Digoxin Concentrations (SDCs)
Intravenous (Adults and Children) Digibind—Dose (mg)=SDC (nanograms/mL) × body weight (kg)/100 × 38; DigiFab—SDC (nanograms/mL) × body weight (kg)/100 × 40.
Unknown Amount Ingested/SDCs Unavailable
Intravenous (Adults and Children) Digibind—760 mg (20 vials); DigiFab—800 mg (20 vials).
Toxicity during chronic digoxin therapy
Intravenous (Adults and Children) Digibind—228 mg (6 vials); DigiFab—240 mg (6 vials).
Powder for injection, lyophilized (Digibind): 38 mg/vial
Powder for injection, lyophilized (DigiFab): 40 mg/vial
- Monitor ECG, pulse, BP, and body temperature before and during treatment. Patients with atrial fibrillation may develop a rapid ventricular response as a result of decreased digoxin levels.
- Assess patient for increase in signs of HF (peripheral edema, dyspnea, rales/crackles, weight gain).
- Lab Test Considerations: Monitor serum digoxin levels before administration.
- Monitor serum potassium levels frequently during treatment. Before treatment, hyperkalemia usually coexists with toxicity. Levels may decrease rapidly; hypokalemia should be treated promptly.
- Free serum digoxin levels fall rapidly after administration. Total serum concentrations rise suddenly after administration but are bound to the Fab molecule and are inactive. Total serum concentrations will decrease to undetectable levels within several days. Serum digoxin levels are not valid for 5–7 days after administration.
Potential Nursing DiagnosesDeficient knowledge, related to medication regimen (Patient/Family Teaching)
- Cardiopulmonary resuscitation equipment and medications should be available during administration.
- Delay redigitalization for several days until the elimination of digoxin immune Fab from the body is complete.
- pH: 6.0–8.0.
- Intermittent Infusion: Diluent: Reconstitute each vial in 4 mL of sterile water for injection and mix gently. Solution will contain a concentration of 9.5 mg/mL (Digibind) or 10 mg/mL (DigiFab). May be further diluted with 0.9% NaCl to achieve the concentration below. Reconstituted solution should be used immediately but is stable for 4 hr if refrigerated. For small doses in infants and children, a reconstituted 38-mg vial can be diluted with 34 mL of 0.9% NaCl (Digibind) or 36 mL of 0.9% NaCl (DigiFab) for a concentration of 1 mg/mL. Concentration: 1 mg/mL.
- Rate: Infuse over 30 min through a 0.22-micron membrane filter. If cardiac arrest is imminent, rapid direct IV injection may be used. Do not use rapid direct injection in other patients because of increased risk of adverse reactions. Small doses in infants and children may be administered with a tuberculin syringe.
- Incompatibility: Information unavailable. Do not mix with other drugs or solutions.
- Explain the procedure and purpose of the treatment to the patient.
- Instruct patient to notify health care provider immediately if signs of delayed allergic reaction (rash, pruritus, urticaria) occur after hospital discharge.
- Resolution of signs and symptoms of digoxin toxicity.
- Decreased digoxin or level without major side effects.
Adverse effects Rare, in patients with a history of allergy, especially to antibiotics; low cardiac output states and congestive heart failure may be exacerbated by withdrawal of the inotropic effects of digitalis. Hypokalemia may occur from re-activation of (sodium, potassium) ATPase