Identification

Summary

Equine Botulinum Neurotoxin A Immune FAB2 is a mixture of antibodies used to treat documented or suspected botulinum toxin exposure.

Brand Names
BAT
Generic Name
Equine Botulinum Neurotoxin A Immune FAB2
DrugBank Accession Number
DB13900
Background

Equine Botulinum Neurotoxin A Immune FAB2 is composed of a mixture of immune globulin fragments purified from plasma of horses that were previously immunized with botulinum toxin serotype A. It is intravenously administered for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A in adults and pediatric patients.

Type
Biotech
Groups
Approved, Experimental, Investigational
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Botulinum Neurotoxin A immune FAB2 (equine)
  • BOTULINUM NEUROTOXIN A IMMUNE FAB2, EQUINE

Pharmacology

Indication

Equine Botulinum Neurotoxin A Immune FAB2 is indicted for use in documented or suspected exposure to botulinum toxin serotype A in adults and pediatric patients [FDA Label].

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

Equine Botulinum Neurotoxin A Immune FAB2 binds to botulinum toxin serotype A to prevent toxicity [FDA Label].

Mechanism of action

Equine Botulinum Neurotoxin A Immune FAB2 is a mix of polyclonal antibodies for Botulinum toxin type A [FDA Label]. It binds to the toxin with high-affinity and prevents binding to ganglioside anchorage sites and membrane-bound receptors on cholinergic nerve terminals. This prevents internalization of the toxin into the cell and ultimately prevents it from exerting its toxic effects. Due to the long-lasting effects of botulinum toxin, the antibodies must be administered before symptoms present to prevent toxicity.

TargetActionsOrganism
ABotulinum neurotoxin type A
antibody
Clostridium botulinum
Absorption

Administration of one vial of containing at least 4500 Units produced a mean Cmax of 2.69 Units/mL. Administration of two vials produced a mean Cmax of 6.23 Units/mL [FDA Label].

Volume of distribution

Equine Botulinum Neurotoxin A Immune FAB2 was found to have a mean Vd of 3.637 L after administration of one vial and 3.993 L after two vials [FDA Label].

Protein binding

There is no protein binding data available.

Metabolism

There is no metabolism data available. Equine Botulinum Neurotoxin A Immune FAB2 is assumed to be broken down similarly to other proteins and antibodies in systemic circulation.

Route of elimination

No data is available on excretion of Equine Botulinum Neurotoxin A Immune FAB2.

Half-life

Equine Botulinum Neurotoxin A Immune FAB2 was observed to have a mean half life of 8.64 h after administration of one vial and 10.20 h after two vials [FDA Label].

Clearance

Equine Botulinum Neurotoxin A Immune FAB2 was observed to have a mean clearance rate of 293 mL/h after administration of one vial and 285 mL/h after two.

Adverse Effects
Adverseeffects
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Toxicity

Equine Botulinum Neurotoxin A Immune FAB2 may produce anapylaxis or anaphylactoid reactions particularly in patients who have previously been exposed to equine-derived antivenom or antitoxins or patient with prexisting hypersensitivity to horses, asthma, or hay fever [FDA Label]. Serum sickness reactions may present 10-21 days after infusion. Various infusion reactions may occur dependent on the rate of infusion. These include chills, fever, headaches, nausea, and vomiting. Arthralgia, myalgia, and vasovagal reactions may also occur independently of infusion rate. Because the antibodies are derived from equine plasma there is a risk of infectious disease transmission although this is controlled through manufacturing processes.

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.
Not Available
Food Interactions
No interactions found.

Products

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
BatEquine Botulinum Neurotoxin A Immune FAB2 (4500 [iU]/10mL) + Equine Botulinum Neurotoxin B Immune FAB2 (3300 [iU]/10mL) + Equine Botulinum Neurotoxin C Immune FAB2 (3000 [iU]/10mL) + Equine Botulinum Neurotoxin D Immune FAB2 (600 [iU]/10mL) + Equine Botulinum Neurotoxin E Immune FAB2 (5100 [iU]/10mL) + Equine Botulinum Neurotoxin F Immune FAB2 (3000 [iU]/10mL) + Equine Botulinum Neurotoxin G Immune FAB2 (600 [iU]/10mL)LiquidIntravenousEmergent BioSolutions Canada Inc.2013-03-01Not applicableUS flag

Categories

Drug Categories
Not Available
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
Not Available

Chemical Identifiers

UNII
LE3J6I6DXP
CAS number
Not Available

References

General References
Not Available
PubChem Substance
347911469
RxNav
1722696
FDA label
Download (204 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
LiquidIntravenous
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Targets

Drugtargets2
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Kind
Protein
Organism
Clostridium botulinum
Pharmacological action
Yes
Actions
Antibody
General Function
Zinc ion binding
Specific Function
Inhibits acetylcholine release. The botulinum toxin binds with high affinity to peripheral neuronal presynaptic membrane to the secretory vesicle protein SV2. It binds directly to the largest lumin...
Gene Name
botA
Uniprot ID
P10845
Uniprot Name
Botulinum neurotoxin type A
Molecular Weight
149452.615 Da

Drug created at September 08, 2017 20:22 / Updated at June 19, 2021 00:27