Human botulinum neurotoxin A/B immune globulin
Identification
- Summary
Human botulinum neurotoxin A/B immune globulin is human-derived IgG antibodies against botulism toxin types A and B used in the treatment of infant botulism.
- Brand Names
- Babybig
- Generic Name
- Human botulinum neurotoxin A/B immune globulin
- DrugBank Accession Number
- DB14115
- Background
Infant botulism is a rare infectious disease occurring in infants in which Clostridium botulinum colonize the large intestine and being to produce botulinum neurotoxin directly in the gut. As these neurotoxins interfere with cholinergic nervous transmission, patients initially present with evident of loss of muscle tone (e.g. constipation, ptosis, feeding difficulties) which may progress to more serious symptoms such as respiratory arrest and flaccid paralysis.2,3
BabyBIG (human-derived botulism immunoglobulin) was approved for use by the FDA in 20031 and has since been used to treat more than 2100 cases of infant botulism.5 It is produced and distributed by the Calfornia Department of Public Health's Infant Botulism Treatment and Prevention Program4 and comprises IgG antibodies derived from pooled adult plasma from persons immunized with recombinant botulinum vaccine who have high titers of neutralizing antibodies against botulinum toxin.1
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- BabyBIG
- Botulism immune globulin intravenous (human)
- Botulism immune globulin intravenous (human) (BIG-IV)
- Botulism immune globulin IV human
- Human-derived botulism antitoxin antibodies
Pharmacology
- Indication
Human-derived botulism immune globulin is indicated for the treatment of infant botulism caused by toxin types A or B in patients ≤1 year of age.1
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Infant botulism •••••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• - Contraindications & Blackbox Warnings
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- Pharmacodynamics
Not Available
- Mechanism of action
Infant botulism is a rare infectious form of botulism in which spores of Clostridium botulinum colonize the large intestine. In contrast to foodborne botulism, in which botulinum toxin is ingested by eating contaminated food, patients with infant botulism produce botulinum toxin directly in the large intestine owing to its colonization by C. botulinum.1
Human-derived botulism immunoglobulin, also called BabyBIG, comprises purified human immunoglobulin G directed against botulinum neurotoxins A and B.1 It is derived from pooled adult plasma from persons immunized with recombinant botulinum vaccine, who were then selected for their high titers of neutralizing antibodies against botulinum toxins A and B.1 These neutralizing antibodies, when administered to the patient, serve to bind to and neutralize circulating botulinum toxin.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
The half-life of human-derived botulism immunoglobulin is approximately 28 days in infants, which is similar to other immunoglobulin preparations.1
- Clearance
Not Available
- Adverse Effects
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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.Not Available
- Food Interactions
- No interactions found.
Products
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- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image BabyBIG Injection, powder, lyophilized, for solution 50 mg/1mL Intravenous California Department Of Public Health 2003-10-23 Not applicable US
Categories
- 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
- Not Available
Chemical Identifiers
- UNII
- X641Y30OA7
- CAS number
- Not Available
References
- General References
- FDA Approved Drug Products: BabyBIG (botulism immune globulin, human) lyophilized powder for reconstitution for intravenous injection [Link]
- Infant Botulism Treatment and Prevention Program: Frequently Asked Questions [Link]
- Centers for Disease Control and Prevention: Infant Botulism [Link]
- California Department of Public Health: Infant Botulism Treatment and Prevention Program [Link]
- Infant Botulism Treatment and Prevention Program: What is BabyBIG? [Link]
- External Links
Clinical Trials
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Intravenous 50 mg/1mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at June 22, 2018 20:26 / Updated at January 22, 2022 00:13