Digoxin immune fab: Difference between revisions

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__NOTOC__
{{DrugProjectFormSinglePage
{{Digoxin immune fab}}
|authorTag=
{{CMG}}; {{AE}} {{AK}}


'''''For patient information about Digoxin immune fab, click [[Digoxin immune fab (patient information)|here]].'''''


{{SB}}
DIGIFAB <sup>®</sup> injection
==Overview==
'''Digoxin Immune Fab (Ovine)''' is the generic name for an antidote for overdose of [[digitalis]].<ref name="pmid11150387">{{cite journal |author=DiDomenico RJ, Walton SM, Sanoski CA, Bauman JL |title=Analysis of the use of digoxin immune fab for the treatment of non-life-threatening digoxin toxicity |journal=J. Cardiovasc. Pharmacol. Ther. |volume=5 |issue=2 |pages=77–85 |year=2000 |pmid=11150387 |doi=}}</ref> It is made from immunoglobin fragments from [[sheep]] who have already been immunized with a digoxin derivative, [[digoxindicarboxymethoxylamine]] (DDMA). Its brand names include Digibind and DigiFab, with the former manufactured by [[GlaxoSmithKline]] and the latter manufactured by Protherics, Inc.
==Category==


[[Digitalis]] antidote.
<!--Overview-->


==FDA Package Insert==
|genericName=


====DIGIFAB<sup>®</sup>====


'''  [[Digoxin Immune Fab indications and usage|Indications and Usage]]'''
'''| [[Digoxin Immune Fab dosage and administration|Dosage and Administration]]'''
'''| [[Digoxin Immune Fab contraindications|Contraindications]]'''
'''| [[Digoxin Immune Fab adverse reactions|Adverse Reactions]]'''
'''| [[Digoxin Immune Fab drug interactions|Drug Interactions]]'''
'''| [[Digoxin Immune Fab use in specific populations|Use in Specific Populations]]'''
'''| [[Digoxin Immune Fab overdosage|Overdosage]]'''
'''| [[Digoxin Immune Fab description|Description]]'''
'''| [[Digoxin Immune Fab clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Digoxin Immune Fab nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[Digoxin Immune Fab how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[Digoxin Immune Fab patient counseling information|Patient Counseling Information]]'''
'''| [[Digoxin Immune Fab labels and packages|Labels and Packages]]'''


==Mechanism of Action==
|aOrAn=
DigiFab has an affinity for digoxin in the range of 109 to 1010 M-1, which is greater than the affinity of [[digoxin]] for its sodium pump receptor, the presumed receptor for its therapeutic and toxic effects. When administered to the intoxicated patient, DigiFab binds to molecules of digoxin reducing free digoxin levels, which results in a shift in the equilibrium away from binding to the receptors, thereby reducing cardio-toxic effects. Fab-digoxin complexes are then cleared by the kidney and [[reticuloendothelial system]].


==References==
a
 
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{{Reflist|2}}
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6832767f-db6b-4eea-b88b-bdfc905749e1
[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drug]]

Revision as of 23:32, 4 July 2014

Digoxin immune fab
Black Box Warning
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];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Digoxin immune fab is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

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

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 adult 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 adult patients.

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

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • 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

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

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

{{#ask: Page Name::Digoxin immune fab |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Digoxin immune fab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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