Anthrax immune globulin human

Identification

Name
Anthrax immune globulin human
Accession Number
DB09057
Description

Anthrax immune globulin is a human antibody given with antibiotics for the treatment of anthrax. It is derived from the plasma of humans immunized with BioThrax (adsorbed anthrax vaccine), which is then further purified. Available as the product Anthrasil (FDA), the result is a solution for slow IV infusion containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. This binding of antibody to PA prevents PA-mediated cellular entry of toxic factors. It is administered in combination with appropriate antibiotic therapy as the immunoglobulin itself is not known to have direct antibacterial activity against anthrax bacteria, which otherwise may continue to grow and produce anthrax toxins.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Anthrax immune globulin (human)
  • Anthrax immune globulin human
  • Anthrax immunoglobulin (human)
  • Bacillus anthracis immune globulin human

Pharmacology

Indication

Anthrax immune globulin is indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.

Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics
Not Available
Mechanism of action

Polyclonal anthrax immune globulin is a passive immunizing agent that neutralizes anthrax toxin by binding to Protective Antigen (PA) to prevent PA-mediated cellular entry of anthrax edema factor and lethal factor. It is administered in combination with appropriate antibiotic therapy as the immunoglobulin itself is not known to have direct antibacterial activity against anthrax bacteria, which otherwise may continue to grow and produce anthrax toxins.

TargetActionsOrganism
AProtective antigen
antibody
Bacillus anthracis
Absorption

Peak levels were reached immediately after infusion and then declined over the duration of study (84 days). Mean activity remained above the lower limit of quantitation (5 milliunits per mL) over the entire 84-day post-dose period for the three doses studied. Cmax was found to be 83.0 mU/mL while Tmax was found to be 0.116 days.

Volume of distribution

5714.8 mL

Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life

24.3 days

Clearance

174.2 mL/day

Adverse Effects
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Toxicity

The most common adverse reactions to Anthrasil observed in >5% of healthy volunteers in clinical trials were headache, infusion site pain and swelling, nausea, and back pain.

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.
DrugInteraction
AbataceptThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Abatacept.
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Anthrax immune globulin human.
AdalimumabThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Alemtuzumab.
AlirocumabThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Alirocumab.
AltretamineThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Anakinra.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AnthrasilLiquid60 [iU]/35mLIntravenousEmergent BioSolutions Canada Inc.2015-10-05Not applicableUS flag
AnthrasilSolution60 unitIntravenousEmergent Biosolutions Canada Inc2018-09-26Not applicableCanada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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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

Chemical Identifiers

UNII
VKZ83S945Z
CAS number
Not Available

References

General References
  1. Mytle N, Hopkins RJ, Malkevich NV, Basu S, Meister GT, Sanford DC, Comer JE, Van Zandt KE, Al-Ibrahim M, Kramer WG, Howard C, Daczkowski N, Chakrabarti AC, Ionin B, Nabors GS, Skiadopoulos MH: Evaluation of intravenous anthrax immune globulin for treatment of inhalation anthrax. Antimicrob Agents Chemother. 2013 Nov;57(11):5684-92. doi: 10.1128/AAC.00458-13. Epub 2013 Aug 26. [PubMed:23979731]
PubChem Substance
347910401
RxNav
1722335
Drugs.com
Drugs.com Drug Page
Wikipedia
Anthrax_immune_globulin
AHFS Codes
  • 80:04.00 — Serums
FDA label
Download (4.37 MB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
Not AvailableNot Yet RecruitingNot AvailableAnthrax1
Not AvailableNot Yet RecruitingNot AvailableInhaled anthrax caused by Bacillus anthracis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
LiquidIntravenous60 [iU]/35mL
SolutionIntravenous60 unit
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

Kind
Protein
Organism
Bacillus anthracis
Pharmacological action
Yes
Actions
Antibody
General Function
Metal ion binding
Specific Function
One of the three proteins composing the anthrax toxin, the agent which infects many mammalian species and that may cause death. PA binds to a receptor (ATR) in sensitive eukaryotic cells, thereby f...
Gene Name
pagA
Uniprot ID
P13423
Uniprot Name
Protective antigen
Molecular Weight
85810.325 Da

Drug created on May 11, 2015 12:08 / Updated on September 25, 2020 15:13

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