NAV

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
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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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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofInfant 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
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
BabyBIGInjection, powder, lyophilized, for solution50 mg/1mLIntravenousCalifornia Department Of Public Health2003-10-23Not applicableUS flag

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
  1. FDA Approved Drug Products: BabyBIG (botulism immune globulin, human) lyophilized powder for reconstitution for intravenous injection [Link]
  2. Infant Botulism Treatment and Prevention Program: Frequently Asked Questions [Link]
  3. Centers for Disease Control and Prevention: Infant Botulism [Link]
  4. California Department of Public Health: Infant Botulism Treatment and Prevention Program [Link]
  5. Infant Botulism Treatment and Prevention Program: What is BabyBIG? [Link]
RxNav
544488

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, lyophilized, for solutionIntravenous50 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