Digoxin Immune Fab (Ovine)

Identification

Summary

Digoxin Immune Fab (Ovine) is an antibody binding fragment which binds digoxin molecules which is used as an antidote to digoxin overdose.

Brand Names
Digifab
Generic Name
Digoxin Immune Fab (Ovine)
DrugBank Accession Number
DB00076
Background

Digoxin Immune Fab is a sheep antibody (26-10) FAB fragment from sheep immunized with the digoxin derivative Digoxindicarboxymethylamine. It is used as an antidote for overdose of digoxin.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Structure
Db00076
Protein Chemical Formula
C2085H3223N553O672S16
Protein Average Weight
47301.7 Da
Sequences
>26-10 Heavy chain (murine)
EVQLQQSGPELVKPGASVRMSCKSSGYIFTDFYMNWVRQSHGKSLDYIGYISPYSGVTGY
NQKFKGKATLTVDKSSSTAYMELRSLTSEDSAVYYCAGSSGNKWAMDYWGHGASVTVSSA
KTTAPSVYPLAPVCGDTTGSSVTLGCLVKGYFPEPVTLTWNSGSLSSGVHTFPAVLQSDL
YTLSSSVTVTSSTWPSQSITCNVAHPASSTKVDKKIEP
>26-10 Light chain (murine)
DVVMTQTPLSLPVSLGDQASISCRSSQSLVHSNGNTYLNWYLQKAGQSPKLLIYKVSNRF
SGVPDRFSGSGSGTDFTLKISRVEAEDLGIYFCSQTTHVPPTFGGGTKLEIKRADAAPTV
SIFPPSSEQLTSGGASVVCFLNNFYPKDINVKWKIDGSERQNGVLNSWTDQDSKDSTYSM
SSTLTLTKDEYERHNSYTCEATHKTSTSPIVKSFNRNEC
Download FASTA Format
Synonyms
  • Digitalis antitoxin
  • Digoxin Immune Fab, Ovine
  • Digoxin-specific Antibody Fragments
  • Ovine digoxin immune fab

Pharmacology

Indication

For treatment of digitoxin overdose or digitalis glycoside toxicity.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

DigiFab binds molecules of digoxin, making them unavailable for binding at their site of action on cells in the body. The Fab fragment-digoxin complex accumulates in the blood, from which it is excreted by the kidney. The net effect is to shift the equilibrium away from binding of digoxin to its receptors in the body, thereby reversing its effects.

Mechanism of action

Binds excess digoxin or digitoxin molecules circulating in the blood.

TargetActionsOrganism
ADigoxin
other/unknown
Humans
Absorption

Not Available

Volume of distribution
  • 0.3 L/kg [DigiFab]
  • 0.4 L/kg [Digibind]
Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Cumulative urinary excretion of digoxin was comparable for both products and exceeded 40% of the administered dose by 24 hours.

Half-life

15-20 hrs

Clearance

Not Available

Adverse Effects
Adverseeffects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Digoxin Immune Fab (Ovine).
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Digoxin Immune Fab (Ovine).
AducanumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Aducanumab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Alemtuzumab.
AlirocumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Alirocumab.
AmivantamabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Amivantamab.
AnifrolumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Anifrolumab.
AnsuvimabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Anthrax immune globulin human.
Antilymphocyte immunoglobulin (horse)The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Antilymphocyte immunoglobulin (horse).
Interactions
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Food Interactions
No interactions found.

Products

Products2
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Active Moieties
NameKindUNIICASInChI Key
Digoxinunknown73K4184T5920830-75-5LTMHDMANZUZIPE-PUGKRICDSA-N
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
DigibindPowder, for solution38 mg / vialIntravenousGlaxosmithkline Inc1995-12-312013-02-06Canada flag
DigibindInjection, powder, for solution38 mg/1IntravenousGlaxosmithkline Inc1986-07-142013-01-31US flag
DigiFabInjection, powder, for solution40 mg/1IntravenousBTG International Inc.2001-08-31Not applicableUS flag
DigiFabPowder, for solution40 mg / vialIntravenousBtg International Inc2011-11-04Not applicableCanada flag
DigiFabInjection, powder, lyophilized, for solution38 mg/1IntravenousSavage Laboratories a division of Fougera Pharmaceuticals Inc.2001-08-312014-08-31US flag

Categories

ATC Codes
V03AB24 — Digitalis antitoxin
Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
YB12NQZ1YN
CAS number
Not Available

References

General References
Not Available
PubChem Substance
46506432
RxNav
1745257
PharmGKB
PA164769030
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Digoxin_Immune_Fab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4RecruitingPreventionAcute Kidney Injury (AKI)1
4Unknown StatusTreatmentHemodialysis Treatment / High Blood Pressure (Hypertension)1
2CompletedTreatmentBipolar Disorder (BD)1
2CompletedTreatmentProphylaxis of preeclampsia1
2, 3TerminatedTreatmentPre-Eclampsia, Severe1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
  • GlaxoSmithKline Inc.
  • Savage Labs
Dosage Forms
FormRouteStrength
Injection, powder, for solutionIntravenous38 mg/1
Powder, for solutionIntravenous38 mg / vial
Injection, powder, for solutionIntravenous40 mg/1
Injection, powder, lyophilized, for solutionIntravenous38 mg/1
Powder, for solutionIntravenous40 mg / vial
Prices
Unit descriptionCostUnit
Digibind 38 mg vial727.91USD vial
Digifab 40 mg vial615.6USD vial
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
melting point (°C)61 °C (FAB fragment)Vermeer, A.W.P. & Norde, W., Biophys. J. 78:394-404 (2000)
hydrophobicity-0.343Not Available
isoelectric point8.01Not Available

Targets

Drugtargets2
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Kind
Small molecule
Organism
Humans
Pharmacological action
Yes
Actions
Other/unknown
References
  1. Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? Nat Rev Drug Discov. 2006 Dec;5(12):993-6. [Article]
  2. Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006 Oct;5(10):821-34. [Article]
  3. McMillin GA, Owen WE, Lambert TL, De BK, Frank EL, Bach PR, Annesley TM, Roberts WL: Comparable effects of DIGIBIND and DigiFab in thirteen digoxin immunoassays. Clin Chem. 2002 Sep;48(9):1580-4. [Article]
  4. Chhatre S, Thillaivinayagalingam P, Francis R, Titchener-Hooker NJ, Newcombe AR, Keshavarz-Moore E: Decision-support software for the industrial-scale chromatographic purification of antibodies. Biotechnol Prog. 2007 Jul-Aug;23(4):888-94. Epub 2007 Jul 13. [Article]
  5. Thillaivinayagalingam P, Newcombe AR, O'Donovan K, Francis R, Keshavarz-Moore E: Detection and quantification of affinity ligand leaching and specific antibody fragment concentration within chromatographic fractions using surface plasmon resonance. Biotechnol Appl Biochem. 2007 Dec;48(Pt 4):179-88. [Article]
  6. Betten DP, Vohra RB, Cook MD, Matteucci MJ, Clark RF: Antidote use in the critically ill poisoned patient. J Intensive Care Med. 2006 Sep-Oct;21(5):255-77. [Article]

Drug created on June 13, 2005 13:24 / Updated on October 24, 2021 16:00