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Drug overview for DIGIFAB (digoxin immune fab):
Generic name: DIGOXIN IMMUNE FAB
Drug class: Digoxin Immune Fab
Therapeutic class: Antidotes and other Reversal Agents
Digoxin immune Fab (ovine) is a monovalent preparation containing ovine immunoglobulin Fab fragments capable of binding digoxin.
No enhanced Uses information available for this drug.
Generic name: DIGOXIN IMMUNE FAB
Drug class: Digoxin Immune Fab
Therapeutic class: Antidotes and other Reversal Agents
Digoxin immune Fab (ovine) is a monovalent preparation containing ovine immunoglobulin Fab fragments capable of binding digoxin.
No enhanced Uses information available for this drug.
DRUG IMAGES
DIGIFAB 40 MG VIAL
The following indications for DIGIFAB (digoxin immune fab) have been approved by the FDA:
Indications:
Digitalis toxicity
Professional Synonyms:
Cardiac glycoside toxicity
Digitalis intoxication
Indications:
Digitalis toxicity
Professional Synonyms:
Cardiac glycoside toxicity
Digitalis intoxication
The following dosing information is available for DIGIFAB (digoxin immune fab):
Digoxin immune Fab (ovine) is commercially available in the US as DigiFab(R) (40-mg single-use vials). Although a different preparation of digoxin immune Fab (ovine) also was previously available (Digibind(R)) and product-specific dosage recommendations were required, this other preparation of digoxin immune Fab (ovine) is no longer commercially available in the US.
Digoxin immune Fab (ovine) usually is given as a single dose. If toxicity is not adequately reversed within several hours after administration of the dose or if toxicity recurs, an additional dose of digoxin immune Fab (ovine) may be necessary and clinical judgment should be used to guide dose selection.
The contents of one vial of DigiFab(R) neutralizes approximately 0.5 mg of digoxin. For treatment of life-threatening or potentially life-threatening digoxin toxicity, the dose of digoxin immune Fab (ovine) varies according to the amount of digoxin to be neutralized.
When the amount of digoxin ingested is unknown and cannot be estimated and when serum digoxin concentrations are unavailable, general dosing guidelines can be used and may be adequate to treat most life-threatening digoxin overdosages. (See General Dosing for Digoxin Toxicity under Dosage and Administration: Dosage.)
If the amount of digoxin ingested is known, the dose of digoxin immune Fab (ovine) required to neutralize the cardiac glycoside can be calculated using an estimate of the total body load (TBL) of digoxin, which takes into consideration the amount (mg of digoxin) and bioavailability of the digoxin preparation ingested. Alternatively, the dose of digoxin immune Fab (ovine) can be calculated based on steady-state serum digoxin concentrations. (See Calculated Dose for Digoxin Toxicity under Dosage and Administration: Dosage.)
If there is no response to an adequate dose of digoxin immune fab (ovine), the possibility that the clinical problem is not caused by digitalis intoxication should be considered and the diagnosis should be re-evaluated.
When a calculated dose of digoxin immune Fab (ovine) is used, clinicians should consider that an inaccurate estimate of the amount of digoxin ingested or absorbed may occur if serum digoxin concentrations were not measured at steady state or were outside measurable limits of the assay used (digoxin assay kits are designed to measure serum concentrations less than 5 ng/mL; dilution of the serum sample is required to accurately measure digoxin concentrations exceeding 5 ng/mL).
Clinicians also should consider that an average steady-state volume of distribution of digoxin (5 L/kg) is used to convert serum digoxin concentrations to TBL of digoxin, but the volume of distribution of the drug may vary widely among individuals. Therefore, many patients may require a higher dose of digoxin immune Fab (ovine) for complete neutralization and doses should be rounded up to the nearest whole vial.
If the dose of digoxin immune Fab (ovine) estimated based on the acute ingested dose of digoxin differs substantially from the dose calculated using the serum digoxin concentration, the manufacturer states that it may be preferable to use the higher dose.
Digoxin immune Fab (ovine) usually is given as a single dose. If toxicity is not adequately reversed within several hours after administration of the dose or if toxicity recurs, an additional dose of digoxin immune Fab (ovine) may be necessary and clinical judgment should be used to guide dose selection.
The contents of one vial of DigiFab(R) neutralizes approximately 0.5 mg of digoxin. For treatment of life-threatening or potentially life-threatening digoxin toxicity, the dose of digoxin immune Fab (ovine) varies according to the amount of digoxin to be neutralized.
When the amount of digoxin ingested is unknown and cannot be estimated and when serum digoxin concentrations are unavailable, general dosing guidelines can be used and may be adequate to treat most life-threatening digoxin overdosages. (See General Dosing for Digoxin Toxicity under Dosage and Administration: Dosage.)
If the amount of digoxin ingested is known, the dose of digoxin immune Fab (ovine) required to neutralize the cardiac glycoside can be calculated using an estimate of the total body load (TBL) of digoxin, which takes into consideration the amount (mg of digoxin) and bioavailability of the digoxin preparation ingested. Alternatively, the dose of digoxin immune Fab (ovine) can be calculated based on steady-state serum digoxin concentrations. (See Calculated Dose for Digoxin Toxicity under Dosage and Administration: Dosage.)
If there is no response to an adequate dose of digoxin immune fab (ovine), the possibility that the clinical problem is not caused by digitalis intoxication should be considered and the diagnosis should be re-evaluated.
When a calculated dose of digoxin immune Fab (ovine) is used, clinicians should consider that an inaccurate estimate of the amount of digoxin ingested or absorbed may occur if serum digoxin concentrations were not measured at steady state or were outside measurable limits of the assay used (digoxin assay kits are designed to measure serum concentrations less than 5 ng/mL; dilution of the serum sample is required to accurately measure digoxin concentrations exceeding 5 ng/mL).
Clinicians also should consider that an average steady-state volume of distribution of digoxin (5 L/kg) is used to convert serum digoxin concentrations to TBL of digoxin, but the volume of distribution of the drug may vary widely among individuals. Therefore, many patients may require a higher dose of digoxin immune Fab (ovine) for complete neutralization and doses should be rounded up to the nearest whole vial.
If the dose of digoxin immune Fab (ovine) estimated based on the acute ingested dose of digoxin differs substantially from the dose calculated using the serum digoxin concentration, the manufacturer states that it may be preferable to use the higher dose.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for DIGIFAB (digoxin immune fab):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for DIGIFAB (digoxin immune fab):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Severe renal impairment |
The following adverse reaction information is available for DIGIFAB (digoxin immune fab):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Hypokalemia Worsening of chronic heart failure |
There are 2 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Orthostatic hypotension Phlebitis after infusion |
The following precautions are available for DIGIFAB (digoxin immune fab):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Animal reproduction studies have not been performed with digoxin immune Fab (ovine) and it is not known whether the immune Fab can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Digoxin immune Fab (ovine) should be used during pregnancy only when clearly needed.
Since it is not known whether digoxin immune Fab (ovine) is distributed into milk, the immune Fab should be used with caution in nursing women and should only be used in such women when clearly needed.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for DIGIFAB (digoxin immune fab):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DIGIFAB (digoxin immune fab)'s list of indications:
| Digitalis toxicity | |
| T46.0x1 | Poisoning by cardiac-stimulant glycosides and drugs of similar action, accidental (unintentional) |
| T46.0x1A | Poisoning by cardiac-stimulant glycosides and drugs of similar action, accidental (unintentional), initial encounter |
| T46.0x1D | Poisoning by cardiac-stimulant glycosides and drugs of similar action, accidental (unintentional), subsequent encounter |
| T46.0x2 | Poisoning by cardiac-stimulant glycosides and drugs of similar action, intentional self-harm |
| T46.0x2A | Poisoning by cardiac-stimulant glycosides and drugs of similar action, intentional self-harm, initial encounter |
| T46.0x2D | Poisoning by cardiac-stimulant glycosides and drugs of similar action, intentional self-harm, subsequent encounter |
| T46.0x3A | Poisoning by cardiac-stimulant glycosides and drugs of similar action, assault, initial encounter |
| T46.0x4 | Poisoning by cardiac-stimulant glycosides and drugs of similar action, undetermined |
| T46.0x4A | Poisoning by cardiac-stimulant glycosides and drugs of similar action, undetermined, initial encounter |
| T46.0x4D | Poisoning by cardiac-stimulant glycosides and drugs of similar action, undetermined, subsequent encounter |
| T46.0x5 | Adverse effect of cardiac-stimulant glycosides and drugs of similar action |
| T46.0x5A | Adverse effect of cardiac-stimulant glycosides and drugs of similar action, initial encounter |
| T46.0x5D | Adverse effect of cardiac-stimulant glycosides and drugs of similar action, subsequent encounter |
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