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Overview
- Description
- A medication used to treat exposure to botulinum toxin, which is a type of toxin that affects the brain.
- Description
- A medication used to treat exposure to botulinum toxin, which is a type of toxin that affects the brain.
- DrugBank ID
- DB13900
- Type
- Biotech
- Clinical Trials
- Phase 0
- 0
- Phase 1
- 0
- Phase 2
- 0
- Phase 3
- 0
- Phase 4
- 0
- Mechanism of Action
- BoNT/A (Clostridium botulinum)Antibody
- BoNT/A (Clostridium botulinum)
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].
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Symptomatic botulism Regimen in combination with: Equine Botulinum Neurotoxin B Immune FAB2 (DB13903), Equine Botulinum Neurotoxin D Immune FAB2 (DB13902), Equine Botulinum Neurotoxin G Immune FAB2 (DB13899), Equine Botulinum Neurotoxin F Immune FAB2 (DB13901), Equine Botulinum Neurotoxin E Immune FAB2 (DB13897), Equine Botulinum Neurotoxin C Immune FAB2 (DB13898) •••••••••••• Reversal of Symptomatic botulism caused by clostridium botulinum serotype a •••••••••••• - Contraindications & Blackbox Warnings
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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.
Target Actions Organism ABoNT/A antibodyClostridium 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
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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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Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Bat 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 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) Liquid Intravenous Emergent BioSolutions Canada Inc. 2013-03-01 Not applicable US 
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
- External Links
- FDA label
- Download (204 KB)
Clinical Trials
- Clinical Trials
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Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Liquid Intravenous - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Targets
Drug created at September 08, 2017 20:22 / Updated at September 05, 2024 06:30