Digoxin immune fab

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

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

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).

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

• Dosage

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

• Oral

• Intravenous

Monitoring

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

Condition1

• Description

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

Clinical data
AHFS/Drugs.com	Consumer Drug Information
Pregnancy category	US: C (Risk not ruled out)
Routes of administration	IV infusion, injection
ATC code	V03AB24 (WHO)
Pharmacokinetic data
Elimination half-life	15 hours for DigiFab, 23 hours for Digibind
Excretion	Renal
Identifiers
IUPAC name Anti-digoxin antibody fragment
DrugBank	DB00076 Y
ChemSpider	NA Y
ChEMBL	ChEMBL1201588 N
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C6394H9908N1698O2011S58
Molar mass	144602.257 g/mol
NY (what is this?)  (verify)

Mechanism of Action

Structure

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

• Digibind®

• Digifab®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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