Equine Botulinum Neurotoxin D Immune FAB2

Identification

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Name
Equine Botulinum Neurotoxin D Immune FAB2
Accession Number
DB13902
Type
Biotech
Groups
Approved, Experimental, Investigational
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
Description

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

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
  • Botulinum Neurotoxin D immune FAB2 (equine)
  • BOTULINUM NEUROTOXIN D IMMUNE FAB2, EQUINE
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
BatEquine Botulinum Neurotoxin D Immune FAB2 (600 [iU]/10mL) + Equine 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 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
Categories
Not Available
UNII
30Y9N0SEBE
CAS number
Not Available

Pharmacology

Indication

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

Associated Conditions
Pharmacodynamics

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

Mechanism of action

Equine Botulinum Neurotoxin D Immune FAB2 is a mix of polyclonal antibodies for botulinum toxin type D [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 D
antibody
Clostridium botulinum
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption

Administration of one vial of containing at least 600 Units produced a mean Cmax of 0.81 Units/mL. Administration of two vials produced a mean Cmax of 1.60 Units/mL [FDA Label].

Volume of distribution

Equine Botulinum Neurotoxin D Immune FAB2 was found to have a mean Vd of 1.465 L after administration of one vial and 1.653 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 D 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 D Immune FAB2.

Half life

Equine Botulinum Neurotoxin D Immune FAB2 was observed to have a mean half life of 7.51 h after administration of one vial and 7.77 h after two vials [FDA Label].

Clearance

Equine Botulinum Neurotoxin D Immune FAB2 was observed to have a mean clearance rate of 137 mL/h after administration of one vial and 151 mL/h after two.

Toxicity

Equine Botulinum Neurotoxin D Immune FAB2 may produce anaphylaxis or anaphylactoid reactions particularly in patients who have previously been exposed to equine-derived antivenom or antitoxins or patient with preexisting 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.

Affected organisms
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.
Not Available
Food Interactions
Not Available

References

General References
Not Available
External Links
PubChem Substance
347911471
FDA label
Download (204 KB)

Clinical Trials

Clinical Trials
Not Available

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

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
Protein
Organism
Clostridium botulinum
Pharmacological action
Yes
Actions
Antibody
General Function
Botulinum toxin acts by inhibiting neurotransmitter release. It binds to peripheral neuronal synapses, is internalized and moves by retrograde transport up the axon into the spinal cord where it can move between postsynaptic and presynaptic neurons. It inhibits neurotransmitter release by acting as a zinc endopeptidase that cleaves the '60-Lys-|-Leu-61' bond of synaptobrevins-1 and -2.
Specific Function
Metalloendopeptidase activity
Gene Name
botD
Uniprot ID
P19321
Uniprot Name
Botulinum neurotoxin type D
Molecular Weight
146871.005 Da

Drug created on September 08, 2017 14:22 / Updated on September 02, 2019 20:08