Digoxin immune fab

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Digoxin immune fab
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Digoxin immune fab is a Immunoglobulin G antidote that is FDA approved for the {{{indicationType}}} of potentially life-threatening digoxin toxicity or overdose. Common adverse reactions include hypokalemia, exacerbation of low cardiac output, and rapid ventricular response in patients with atrial fibrillation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
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Condition3
  • Dosing Information
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Condition4
  • Dosing Information
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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Digoxin immune fab in adult patients.

Non–Guideline-Supported Use

Toxic Ingestions of Lanatoside C
  • Dosing Information
  • Fab fragments (500 mg) were added to 500 mL dextrose 5% in water and infused continuously at 32 drops per minute over a total period of 5.5 hours (total dose, 460 mg).[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Digoxin immune fab in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
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Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Digoxin immune fab in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Digoxin immune fab in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description


Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Digoxin immune fab in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Digoxin immune fab in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Digoxin immune fab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Digoxin immune fab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Digoxin immune fab with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Digoxin immune fab with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Digoxin immune fab with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Digoxin immune fab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Digoxin immune fab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Digoxin immune fab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Digoxin immune fab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Digoxin immune fab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Digoxin immune fab in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

  • All patients should be informed of the possibility of an anaphylactic reaction and when receiving DigiFab should be carefully monitored for signs and symptoms of an acute allergic reaction (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia) and treated immediately with appropriate emergency medical care (e.g., oxygen, diphenhydramine, corticosteroids, volume expansion and airway management).
  • Patients should be closely monitored, including temperature, blood pressure, electrocardiogram, and potassium concentration, during and after administration of DigiFab.
  • Patients with severe renal failure who receive DigiFab for digitalis toxicity should be monitored 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.

IV Compatibility

There is limited information regarding IV Compatibility of Digoxin immune fab in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Digoxin immune fab in the drug label.

Pharmacology

Digoxin immune fab
Systematic (IUPAC) name
Anti-digoxin antibody fragment
Identifiers
CAS number ?
ATC code V03AB24
PubChem ?
DrugBank DB00076
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 144602.257 g/mol
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life 15 hours for DigiFab, 23 hours for Digibind
Excretion Renal
Therapeutic considerations
Pregnancy cat.

C(US)

Legal status
Routes IV infusion, injection

Mechanism of Action

Structure

  • DigiFab® [Digoxin Immune Fab (Ovine)] is a sterile, purified, lyophilized preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments. These fragments are obtained from the blood of healthy sheep immunized with a digoxin derivative, digoxin-dicarboxymethoxylamine (DDMA), a digoxin analogue which contains the functionally essential cyclopentaperhydrophenanthrene:lactone ring moiety coupled to keyhole limpet hemocyanin (KLH).


  • The final product is prepared by isolating the immunoglobulin fraction of the ovine serum, digesting it with papain and isolating the digoxin-specific Fab fragments by affinity

chromatography. These antibody fragments have a molecular weight of approximately 46,000 Da.


  • Each vial of DigiFab, which will bind approximately 0.5 mg digoxin, contains 40 mg of digoxin immune Fab, 75 mg (approx) of mannitol USP, and 2 mg (approx) sodium acetate USP as a buffering agent.


  • The product contains no preservatives and is intended for intravenous administration after reconstitution with 4 mL of Sterile Water for Injection USP.
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Digoxin immune fab in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Digoxin immune fab in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Digoxin immune fab in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Digoxin immune fab in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Digoxin immune fab Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Digoxin immune fab in the drug label.

Precautions with Alcohol

  • Alcohol-Digoxin immune fab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Hess, T. (1979-12). "Treatment of a case of lanatoside C intoxication with digoxin-specific F(ab')2 antibody fragments". American Heart Journal. 98 (6): 767–771. ISSN 0002-8703. PMID 495429. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  2. ↑ "DIGIFAB (ovine digoxin immune fab) injection, powder, lyophilized, for solution".
  3. ↑ "DIGIFAB (ovine digoxin immune fab) injection, powder, lyophilized, for solution".
  4. ↑ "http://www.ismp.org". External link in |title= (help)


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