Digibind

Digibind

 [dij´ĭ-bīnd]
trademark for a preparation of digoxin immune Fab (ovine), an antidote for digoxin or digitoxin overdose.

digoxin immune Fab

(di-jox-in im-myoon fab) ,

Digibind

(trade name),

DigiFab

(trade name)

Classification

Therapeutic: antidotes
Pharmacologic: antibody fragments
Pregnancy Category: C

Indications

Serious life-threatening overdosage with digoxin.

Action

An antibody produced in sheep that binds antigenically to unbound digoxin in serum.

Therapeutic effects

Binding and subsequent removal of digoxin, preventing toxic effects in overdose.

Pharmacokinetics

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)

ROUTEONSETPEAKDURATION
IV30 min (variable)unknown2–6 hr

Contraindications/Precautions

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

Cardiovascular

  • re-emergence of atrial fibrillation
  • re-emergence of HF

Fluid and Electrolyte

  • hypokalemia (life-threatening)

Interactions

Drug-Drug interaction

Prevents therapeutic response to digoxin.

Route/Dosage

Digibind—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).

Availability

Powder for injection, lyophilized (Digibind): 38 mg/vial
Powder for injection, lyophilized (DigiFab): 40 mg/vial

Nursing implications

Nursing assessment

  • 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 Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • 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.
  • Intravenous Administration
  • 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of digoxin toxicity.
    • Decreased digoxin or level without major side effects.

Digibind™

a trademark for the antibody used in the treatment of digoxin toxicity (digoxin immune Fab, ovine).
A therapeutic agent consisting of antigen binding fragments (Fab) derived from antidigoxin antibodies raised in sheep, which have a molecular weight of 46kD. It is used to manage digoxin overdose, and has been used successfully for digitoxin overdose
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
References in periodicals archive ?
The study, known as the Digibind Efficacy Evaluation in Preeclampsia (DEEP) study, was supported in part by Protherics PLC, whose DIF product (marketed in the United States as Digifab) is an alternative to the GlaxoSmithKline's (marketed in the United States as Digibind).
GlaxoSmithKline has a stake in Digibind, which is a member of this family of drugs.
The treating physician ordered 10 vials of the antidote, Digibind, but only three were available in the hospital pharmacy's "night locker.
An example of the latter is Digibind, which consists of Fabfragments of digoxin antibody, administered to neutralize digitalis toxicity.
Digibind, an antidote for digoxin toxicity was administered.
Digoxin toxicity can be rapidly and safely reversed by administration of anti-dioxin immune fragments (Fab) such as DIGIBIND [R], which has been available in the US since 1986.
Patient received 5 vials of digibind in the ER, with digoxin level decreasing to <0.
Benjamin was transferred to the Birmingham hospital to receive the antidote Digibind.
Antibody-targeted imaging reagents Mouse 23 Rat 24 Antibody-targeted drugs Mouse 23 Rat 24 Anti-thymocyte globulin Horse 25 Rabbit 26 Anti-snake venom Horse 27 Calcitonin Salmon 28 Digibind (anti-digoxin Fab) Sheep 29 Factor VIII Pig 30 Insulin Pig 31 Vaccines Rabbit 32 Chicken 33 Patent medicines Rabbit 34 Table 2.
Nonetheless, one can agree that results from the Stratus II and AxSYM may be suitable for monitoring the course of Digibind treatment.
Green, entitled "Serum digoxin in the presence of Digibind: determination of digoxin by the Abbott AxSYM and Baxter Stratus II immunoassays by direct analysis without pretreatment of serum samples" (Clin Chem 1998;44:1947-50), the concentration of Digibind given in parentheses in the sentence at the bottom of the second column on page 1948 is incorrect.
Digibind [R] (Glaxo Wellcome) is the most common brand of anti-digoxin Fab fragments used in the United States and worldwide.