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digoxin immune FAB (Antidote) (Rx)Brand and Other Names:Digibind, DigiFab

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 40mg/vial
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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
more...

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

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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

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Warnings

Contraindications

Hypersensitivity to sheep proteins

Cautions

Serum digoxin levels rise after digibind treatment - do not use serum levels to guide continuing treatment

Hypokalemia may occur from shifting of extracellular potassium to intracellular space; monitor closely

Patients with heart failure may experience symptom exacerbation due to reduction in digoxin serum concentration

Caution in patients with renal failure

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

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.

more...
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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)

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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)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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