Digoxin Immune Fab (Ovine)

Identification

Name
Digoxin Immune Fab (Ovine)
Accession Number
DB00076  (BTD00046, BTD00027, BIOD00046, BIOD00027)
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Description

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.

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
Active Moieties
NameKindUNIICASInChI Key
Digoxinunknown73K4184T5920830-75-5LTMHDMANZUZIPE-PUGKRICDSA-N
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
DigibindPowder, for solution38 mgIntravenousGlaxosmithkline Inc1995-12-312013-02-06Canada
DigibindInjection, powder, for solution38 mg/1IntravenousGlaxosmithkline Inc1986-07-142013-01-31Us
DigiFabPowder, for solution40 mgIntravenousBtg International Inc2011-11-04Not applicableCanada
DigiFabInjection, powder, lyophilized, for solution38 mg/1IntravenousSAVAGE LABORATORIES, A division of Nycomed US Inc.2001-08-31Not applicableUs
DigiFabInjection, powder, for solution40 mg/1IntravenousBtg International Inc2001-08-31Not applicableUs
Categories
UNII
YB12NQZ1YN
CAS number
Not Available

Pharmacology

Indication

For treatment of digitoxin overdose or digitalis glycoside toxicity.

Associated Conditions
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
Human
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
Toxicity
Not Available
Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Digoxin Immune Fab (Ovine).
AbituzumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Abituzumab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Digoxin Immune Fab (Ovine).
AdecatumumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Adecatumumab.
AducanumabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Aducanumab.
AfelimomabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Afelimomab.
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.
AmatuximabThe risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Amatuximab.
AMG 108The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with AMG 108.
Food Interactions
Not Available

References

General References
Not Available
External Links
PubChem Substance
46506432
PharmGKB
PA164769030
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Digoxin_Immune_Fab
ATC Codes
V03AB24 — Digitalis antitoxin
AHFS Codes
  • 92:12.00 — Antidotes
  • 80:04.00 — Serums

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2CompletedTreatmentBipolar Disorder (BD)1
2CompletedTreatmentProphylaxis of preeclampsia1
2RecruitingTreatmentSevere Preeclampsia1
4Unknown StatusTreatmentHemodialysis Treatment / High Blood Pressure (Hypertension)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
  • GlaxoSmithKline Inc.
  • Savage Labs
Dosage forms
FormRouteStrength
Injection, powder, for solutionIntravenous38 mg/1
Powder, for solutionIntravenous38 mg
Injection, powder, for solutionIntravenous40 mg/1
Injection, powder, lyophilized, for solutionIntravenous38 mg/1
Powder, for solutionIntravenous40 mg
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

Taxonomy

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

Targets

Kind
Small molecule
Organism
Human
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. [PubMed:17139284]
  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. [PubMed:17016423]
  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. [PubMed:12194938]
  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. [PubMed:17630695]
  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. [PubMed:17516918]
  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. [PubMed:16946442]

Drug created on June 13, 2005 07:24 / Updated on December 12, 2018 07:01