Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 40mg/vial
Acute Ingestion of Unknown Quantity
Administer 20 vials
Larger dose has faster onset, but may cause febrile reaction; may give 10 vials initially, then at physician's discretion, administer 10 more vials
Each vial of DigiFab (40 mg of Fab) binds 0.5 mg digoxin
Equimolar dose to ingested digoxin (76/80 mg FAB = 1 mg digoxin)
Acute Ingestion of Known Amount
Total digoxin load (mg) divided by 0.5 mg digoxin bound per vial = number of vials to use
Toxicity During Chronic Therapy
Acute distress or for whom a serum digoxin concentration is not available: Administer 6 vials
Renal Impairment
Dose adjustment not necessary but use caution as digoxin immune Fab complex is renally eliminated
Administration
Administer by IV infusion over 15-30 minutes (see IV information)
May be given IVP for life-threatening dysrhythmias
Other Indications & Uses
For life-threatening dysrhythmias or hypotension unresponsive to other measures caused by digoxin, digitoxin or related toxins (ie, foxglove)
[K+] >5 mEq/L in setting of severe digoxin intoxication, especially if increased creatinine
Dosage Forms & Strengths
powder for injection
- 40mg/vial
Acute Ingestion of Unknown Quantity
As adults; administer 20 vials
Larger dose has faster onset, but may cause febrile reaction; may give 10 vials initially, then at physician's discretion, administer 10 more vials;
Small children: Monitor for volume overload
Acute Ingestion of Known Amount
As adults; total digoxin load (mg) divided by 0.5 mg digoxin bound per vial = number of vials to use
Toxicity During Chronic Therapy
Infants and small children (<20 kg): Administer 1 vial
Adverse Effects
Frequency Not Defined
Effects (due to w/d of digitalis) include exacerbation of HF, rapid ventricular response in patients with a.fib; posteral hypotension
Falsely increases digoxin concentrations
Hypokalemia
Loss of disease control
Phlebitis
Fever, May occur with doses above 10 vials
Allergic reactions
Serum sickness
Warnings
Contraindications
None listed by the manufacturer
Cautions
Serum digoxin levels rise after digibind treatment - do not use serum levels to guide continuing treatment
Suicidal ingestion may result from more than one drug; toxic effects of other drugs or poisons should not be overlooked, especially in cases where signs and symptoms of digitalis toxicity are not relieved by administration of this medication
Rapid drop in serum potassium concentration may occur after treatment with this medication; monitor frequently, especially after first several hours of administration
Renal failure
- The elimination half-life of this medication in renal failure has not been clearly defined; monitor patients with severe renal failure who receive this medication for digitalis toxicity for a prolonged period for possible recurrence of toxicity
- Monitoring of free (unbound) digoxin concentrations after the administration may be appropriate in order to establish recrudescent toxicity in renal failure patients
Cardiac function
- Patients with poor cardiac function may deteriorate secondary to withdrawal of inotropic action of digoxin by this medication; if needed, provide additional support by using other intravenous inotropes such as dopamine, dobutamine or vasodilators; however, take additional care not to aggravate digitalis-induced rhythm disturbances
- Postpone re-digitalization, if possible, until the Fab fragments have been eliminated from the body, which may require several days, and patients with impaired renal function may require a week or longer
Hypersensitivity reactions
- Anaphylaxis and hypersensitivity reactions are possible; carefully monitor all for signs and symptoms of an acute allergic reaction (eg, urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia) and treat immediately with appropriate emergency medical care (eg, oxygen, diphenhydramine, corticosteroids, volume expansion, and airway management), if one occurs
- If an anaphylactic reaction occurs during infusion, terminate drug administration at once and administer appropriate treatment; balance the need for epinephrine against potential risk in the setting of digitalis toxicity
- Patients with known allergies to sheep protein are particularly at risk for an anaphylactic reaction, as are individuals who have previously received intact ovine antibodies or ovine Fab
- Do not administer this drug to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh risks and appropriate management for anaphylactic reactions is readily available
- Prior treatment with digoxin-specific ovine immune Fab carries a theoretical risk of sensitization to ovine serum protein and possible diminution of efficacy due to presence of human antibodies against ovine Fab
- To date, there have been no clinical reports of human anti-ovine immunoglobulin antibodies causing a reduction in binding of ovine digoxin immune Fab or neutralization response to ovine digoxin immune Fab
Pregnancy & Lactation
Pregnancy
Animal reproduction studies have not been conducted with this medication; not known whether therapy can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity; only administer to a pregnant woman if clinically needed
Lactation
Not known whether the drug is excreted in human breast milk
Because many drugs are excreted in human milk, exercise caution when administering to a nursing woman; administer to nursing mothers only if clinically needed
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antibody binds digoxin or other cardiac glycosides and it is then excreted by the kidneys and removed from the body
Pharmacokinetics
Onset of action: ≤ 30 min (observed improvement)
Vd: 0.3 L/kg
Half-life elimination: 15-20 hr (prolonged in renal impairment)
Excretion: Urine (amounts undetectable within 5-7 days)
Administration
IV Preparation
Reconstitute with 4 mL SWI to obtain a 9.5 mg/mL Digibind solution or 10 mg/mL DigiFab soln
For infusion further dilute with NS to desired volume
If very small doses are necessary (<3 mg), may dilute with NS to 1 mg/mL
IV Administration
Infuse over 15-30 min
Digibind is administered using 0.22 micron inline filter; DigiFab should NOT be administered through filter
May be given as rapid IVP if cardiac arrest is imminent (generally not recommended due to increased adverse reactions)
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
DigiFab intravenous - | 40 mg vial | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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