Digoxin immune Fab: Drug information

(For additional information see "Digoxin immune Fab: Pediatric drug information" and see "Digoxin immune Fab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

DigiFab

Brand Names: Canada

DigiFab

Pharmacologic Category

Antidote

Dosing: Adult

Note: Each vial of digoxin immune Fab 40 mg will bind ~0.5 mg of digoxin.

Digoxin toxicity

Digoxin toxicity:

Note: For the most contemporary approach to patient selection and dosing recommendations, consultation with a poison control center or a clinical toxicologist is highly recommended.

Estimation of a full neutralizing dose is based on the body burden of digoxin. This may be calculated if the amount ingested is known or the postdistribution serum drug level is known. Round the dose up to the nearest whole vial. If the amount ingested is unknown, general dosing guidelines should be used. Empirical dosing of digoxin immune fab prior to steady-state digoxin serum concentrations may result in an overestimation of the required dose (Ref).

Acute toxicity, full neutralizing dose:

Acute ingestion of unknown amount: IV: Initial: 10 vials; if needed, administer a second dose of 10 vials (20 vials total is adequate to treat most life-threatening ingestions).

Acute ingestion of known amount: IV:

Based on number of tablets or capsules ingested:

Step 1: Calculate total body load (mg)

Digoxin capsules: Note: This assumes 100% bioavailability of digoxin.

Total body load (mg) = Amount (mg) digoxin capsules ingested

Digoxin tablets: Note: This assumes 80% bioavailability of digoxin.

Total body load (mg) = 0.8 x (amount [mg] digoxin tablets ingested)

Step 2: Calculate number of vials needed

Digoxin Immune Fab Dose (vials) = Total body load (mg) x 2

Alternatively, the following table gives an estimation of the number of vials needed based on the number of digoxin tablets or capsules ingested.

**Approximate Dose of Digoxin Immune Fab (in vials) for Reversal of a Single Large Digoxin Overdose**
Number of Digoxin Tablets or Capsules Ingested¹	Dose of Digoxin Immune Fab (# of Vials)
¹250 mcg tablets with 80% bioavailability or 200 mcg capsules with 100% bioavailability.
25	10
50	20
75	30
100	40
150	60
200	80

Chronic toxicity, full neutralizing dose:

Note: Patients who receive digoxin therapeutically often require lower doses than those with acute overdosage because their total body burden of digoxin is generally low comparatively (Ref).

Serum digoxin concentration unknown: IV: 6 vials is adequate to reverse most cases of toxicity.

Steady-state serum digoxin concentration known: Note: If the calculated dose based on the digoxin concentration is different from the estimated dose based on the known ingested amount (if available), use the higher dose.

Digoxin Immune Fab Dose (vials) = (serum digoxin concentration [ng/mL] x weight [kg]) / 100

Alternatively, the following table gives an estimation of the number of vials needed based on the steady-state serum digoxin concentration.

**Adult Dose Estimates of Digoxin Immune Fab (in # of Vials) From Steady-State Serum Digoxin Concentration**
Patient Weight (kg)	Serum Digoxin Concentration (ng/mL)
Patient Weight (kg)	1	2	4	8	12	16	20
40	0.5 vial	1 vial	2 vials	3 vials	5 vials	7 vials	8 vials
60	0.5 vial	1 vial	3 vials	5 vials	7 vials	10 vials	12 vials
70	1 vial	2 vials	3 vials	6 vials	9 vials	11 vials	14 vials
80	1 vial	2 vials	3 vials	7 vials	10 vials	13 vials	16 vials
100	1 vial	2 vials	4 vials	8 vials	12 vials	16 vials	20 vials

Acute or chronic toxicity, low dose (off-label dose): Note: A "low dose" may be sufficient for some patients with acute or chronic digoxin toxicity where neither amount ingested or steady-state level is known, so long as life-threatening toxicity is not present; consultation with a poison control center or a clinical toxicologist is highly recommended for appropriate patient selection and dosing. The "low dose" approach is based on the pharmacokinetic assumption that 1 to 4 vials of digoxin immune Fab is sufficient to bind the free central compartment digoxin in most patients (Ref).

Acute digoxin toxicity: IV: 2 vials; may repeat every ~1 hour if there is no clinical response (Ref).

Chronic digoxin toxicity: IV: 1 to 2 vials; may repeat every ~1 hour if there is no clinical response (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, use with caution since digoxin-digoxin immune Fab complex is renally eliminated. Patients should undergo prolonged monitoring for recurrence of toxicity.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Digoxin immune Fab: Pediatric drug information")

Digoxin toxicity

Digoxin toxicity: Infants, Children, and Adolescents: Note: Estimation of the dose is based on the body burden of digitalis. This may be calculated if the amount ingested is known or the post-distribution serum drug concentration is known (round the dose up to the nearest whole vial). If the amount ingested is unknown, general dosing guidelines should be used.

Acute ingestion of unknown amount: IV: Initial: 10 vials; if needed, may administer a second dose of 10 vials (to avoid a febrile reaction); a total dose of 20 vials is adequate to treat most life-threatening ingestions. In small children (<20 kg), it is important to monitor for fluid overload.

Acute ingestion of known amount: IV:

Step 1: Calculate total body load (mg): If parenteral overdose of digoxin or from ingestion or oral capsules, total body load of digoxin is equal to the dose administered. If oral digoxin ingestion/overdose from elixir or tablets, the total body load should be calculated based on the following equation:

Total body load (mg) = 0.8 x [amount (mg) digoxin tablets or elixir ingested]

Step 2: Calculate number of vials needed: Each vial of digoxin immune Fab 40 mg will bind ~0.5 mg of digoxin.

Digoxin Immune Fab Dose (vials) = Total digoxin body load (mg) / 0.5 mg/vial

Based on steady-state serum digoxin concentration: IV: Dose may be determined by estimation with the following tables or calculated based on the following equations for either mg dose or number of vials needed (use precaution to ensure appropriate equation):

Note: Infants and Children ≤20 kg may require smaller doses; calculate the dose in milligrams (mg)

Digoxin Immune Fab Dose (mg) = [(serum digoxin concentration [ng/mL] x weight [kg]) / 100] x 40 mg/vial

Digoxin Immune Fab Dose (vials) = (serum digoxin concentration [ng/mL] x weight [kg]) / 100

The following tables give an estimation of the amount of Digoxin Immune Fab needed based on the steady-state serum digoxin concentration.

**Infants and Children <20 kg: Dose Estimates of Digoxin Immune Fab (in mg) From Serum Digoxin Concentration**
Patient Weight (kg)	Serum Digoxin Concentration (ng/mL)
Patient Weight (kg)	1 ng/mL	2 ng/mL	4 ng/mL	8 ng/mL	12 ng/mL	16 ng/mL	20 ng/mL
^ADilution of reconstituted vial to 1 mg/mL may be desirable.
3	1 mg^A	2.5 mg^A	5 mg	10 mg	14 mg	19 mg	24 mg
5	2 mg^A	4 mg	8 mg	16 mg	24 mg	32 mg	40 mg
10	4 mg	8 mg	16 mg	32 mg	48 mg	64 mg	80 mg
20	8 mg	16 mg	32 mg	64 mg	96 mg	128 mg	160 mg

**Children and Adolescents ≥40 kg: Dose Estimate of Digoxin Immune Fab (in # of Vials) From Serum Digoxin Concentration**
Patient Weight (kg)	Serum Digoxin Concentration (ng/mL)
Patient Weight (kg)	1 ng/mL	2 ng/mL	4 ng/mL	8 ng/mL	12 ng/mL	16 ng/mL	20 ng/mL
40	0.5 vial	1 vial	2 vials	3 vials	5 vials	7 vials	8 vials
60	0.5 vial	1 vial	3 vials	5 vials	7 vials	10 vials	12 vials
70	1 vial	2 vials	3 vials	6 vials	9 vials	11 vials	14 vials
80	1 vial	2 vials	3 vials	7 vials	10 vials	13 vials	16 vials
100	1 vial	2 vials	4 vials	8 vials	12 vials	16 vials	20 vials

Chronic toxicity (serum digoxin concentration unavailable): IV:

Infants and Children ≤20 kg: 1 vial is adequate to reverse most cases of toxicity

Children >20 kg and Adolescents: 6 vials is adequate to reverse most cases of toxicity

Dosing: Kidney Impairment: Pediatric

All patients: There are no pediatric specific recommendations provided; use with caution; elimination of Fab-digoxin fragments may be prolonged with renal impairment; patients should have serum digoxin levels monitored closely (including unbound if possible) to identify/prevent recurrence of toxicity and to determine an appropriate time for re-digitalization (if applicable).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Orthostatic hypotension, phlebitis, ventricular tachycardia (patients with atrial fibrillation; due to digoxin withdrawal), worsening of heart failure (due to digoxin withdrawal)

Endocrine & metabolic: Hypokalemia

Hypersensitivity: Hypersensitivity reaction, serum sickness

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Digoxin immune Fab is derived from ovine (sheep) Fab immunoglobulin fragments; hypersensitivity reactions (eg, anaphylactic or anaphylactoid reactions, delayed allergic reactions) are possible. Patients with allergies to sheep proteins and patients with prior exposure to ovine antibodies or ovine Fab may be at a higher risk for anaphylactic reactions. In patients who develop an anaphylactic reaction, discontinue the infusion immediately and administer emergency care; balance the need for epinephrine against its potential risk in the setting of digitalis toxicity.

Processed with papain and may cause hypersensitivity reactions in patients allergic to papaya, other papaya extracts, papain, chymopapain, or the pineapple-enzyme bromelain. There may also be cross allergenicity with dust mite and latex allergens.

• Potassium imbalance: Patients experiencing acute digitalis toxicity may present with significant hyperkalemia due to shifting of potassium into the extracellular space. Upon treatment with digoxin immune Fab, potassium shifts back into the intracellular space and may result in hypokalemia. Monitor potassium closely, especially during the first few hours after administration; treat hypokalemia cautiously when clinically indicated.

Disease-related concerns:

• Heart failure (HF): In patients chronically maintained on digoxin for HF, administration of digoxin immune Fab may result in exacerbation of HF symptoms due to a reduction in digoxin serum concentration. If reinitiation is required, consider postponing until Fab fragments have been eliminated completely; elimination may take several days or longer, especially in patients with renal impairment.

• Renal impairment: Use with caution in patients with renal failure (experience limited); the Fab-digoxin complex will be eliminated more slowly. Toxicity may recur; prolonged monitoring for recurrence of symptoms and evaluation of free (unbound) digoxin concentrations (if test available) may be warranted in this patient population.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

DigiFab: 40 mg (1 ea)

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (DigiFab Intravenous)

40 mg (per each): $5,518.80

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

DigiFab: 40 mg (1 ea)

Administration: Adult

IV: Administer by slow IV infusion over at least 30 minutes. May also be given by bolus injection if cardiac arrest is imminent (infusion-related reaction may occur). Stopping the infusion and restarting at a slower rate may help if an infusion-related reaction occurs.

Administration: Pediatric

Parenteral: IV: Administration by IV infusion over at least 30 minutes is preferable. May also be administered by bolus injection if cardiac arrest is imminent (infusion-related reaction may occur). If an infusion-related reaction occurs, discontinue the infusion and reinitiate at a slower rate.

Use: Labeled Indications

Digoxin toxicity: Treatment of life-threatening or potentially life-threatening digoxin intoxication, including:

- Acute digoxin ingestion (≥10 mg in adults; 4 mg [>0.1 mg/kg] in children); resulting in serum concentration ≥10 ng/mL). Note: Serum digoxin concentrations do not reflect myocardial digoxin concentrations until distribution occurs (~4 to 6 hours). Therefore, an initially elevated concentration (in the absence of overt toxicity) may not indicate the use of digoxin immune fab. However, an initial serum concentration in excess of 10 ng/mL may be predictive of toxicity (Hack 2019).

- Chronic ingestion leading to steady state digoxin concentrations >6 ng/mL in adults or >4 ng/mL in children.

- Manifestations of life-threatening digoxin toxicity due to overdose (severe ventricular arrhythmias, progressive bradycardia, second- or third-degree heart block not responsive to atropine, serum potassium concentration >5.5 mEq/L in adults or >6 mEq/L in children).

Use: Off-Label: Adult

Cardiac glycoside toxicity

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted. In general, medications used as antidotes should take into consideration the health and prognosis of the mother; antidotes should be administered to pregnant women if there is a clear indication for use and should not be withheld because of fears of teratogenicity (Bailey, 2003).

Breastfeeding Considerations

It is not known if digoxin immune fab is excreted in breast milk. The manufacturer recommends caution be exercised when administering to nursing women.

Monitoring Parameters

Prior to the first dose of digoxin immune Fab evaluate serum potassium, serum digoxin concentration, and serum creatinine; closely monitor serum potassium (eg, hourly for 4 to 6 hours; at least daily thereafter; elevated serum potassium is associated with increased morbidity and mortality (Hauptman 2016; Rezai 2018). Monitor temperature, blood pressure, and electrocardiogram after administration. Total serum digoxin concentrations will rise precipitously following administration of digoxin immune Fab due to the presence of the Fab-digoxin complex; because digoxin bound to Fab fragments cannot result in toxicity, this rise has no clinical meaning. Therefore, avoid monitoring total serum digoxin concentrations until the Fab fragments have been eliminated completely; this may be several days to weeks in patients with renal impairment (Ujhelyi 1995). Monitor for volume overload in children <20 kg. Monitor for signs and symptoms of a hypersensitivity reaction.

Patients with renal failure may experience a recurrence of toxicity; prolonged monitoring for recurrence of symptoms and evaluation of free (unbound) digoxin concentrations (if test available) may be warranted in this patient population.

Mechanism of Action

Digoxin immune antigen-binding fragments (Fab) are specific antibodies for the treatment of digitalis intoxication in carefully selected patients; binds with molecules of digoxin and is then excreted by the kidneys and removed from the body.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: IV: Digitalis toxicity: Improvement may be seen within 20 to 90 minutes (Betten, 2006)

Distribution: V_d: 0.3 L/kg

Half-life elimination: 15 to 20 hours; may be increased up to 10-fold in patient with renal impairment

Excretion: Urine (concentrations declining within 5 to 7 days)

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AT) Austria: Digitalis antidot;
(AU) Australia: Digibind | Digifab;
(BE) Belgium: Digitalis antidot;
(CZ) Czech Republic: Digifab | Digitalis antidot;
(DE) Germany: Digitalis antidot;
(EE) Estonia: Digibind | Digifab;
(EG) Egypt: Digifab;
(FR) France: Digidot | Digifab;
(GB) United Kingdom: Digibind | Digifab;
(LT) Lithuania: Digifab;
(MY) Malaysia: Digifab;
(NO) Norway: Digifab;
(NZ) New Zealand: Digifab;
(PR) Puerto Rico: Digibind | Digifab;
(PT) Portugal: Digibind | Digifab;
(SG) Singapore: Digifab;
(SK) Slovakia: Digitalis antidot;
(TW) Taiwan: Digifab

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Digoxin immune Fab: Drug information