Anthrax immune globulin human

Identification

Summary

Anthrax immune globulin human is an immunizing agent used for the treatment of inhalational anthrax in adult and pediatric patients in combination with antibacterial agents.

Brand Names
Anthrasil
Generic Name
Anthrax immune globulin human
DrugBank Accession Number
DB09057
Background

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.

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Used in combination to treatInhalational anthrax••••••••••••
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.

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.
AducanumabThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Aducanumab.
AldesleukinThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Aldesleukin.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AnthrasilLiquid60 [iU]/35mLIntravenousEmergent BioSolutions Canada Inc.2015-10-05Not applicableUS flag
AnthrasilSolution60 unit / vialIntravenousEmergent Biosolutions Canada Inc2018-09-26Not applicableCanada 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
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. [Article]
PubChem Substance
347910401
RxNav
1722335
Drugs.com
Drugs.com Drug Page
Wikipedia
Anthrax_immune_globulin
FDA label
Download (4.37 MB)

Clinical Trials

Clinical Trials
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Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package
PhaseStatusPurposeConditionsCountStart DateWhy Stopped100+ additional columns
Not AvailableNot Yet RecruitingNot AvailableAnthrax1somestatusstop reasonjust information to hide
Not AvailableNot Yet RecruitingNot AvailableInhalational Anthrax1somestatusstop reasonjust information to hide

Pharmacoeconomics

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

Properties

State
Solid
Experimental Properties
Not Available

Targets

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Kind
Protein
Organism
Bacillus anthracis
Pharmacological action
Yes
Actions
Antibody
General Function
Protective antigen constitutes one of the three proteins composing the anthrax toxin; it mediates attachment to host cells and translocation of edema factor (EF) and lethal factor (LF) into the host cytoplasm (PubMed:11700562, PubMed:14507921, PubMed:15243628, PubMed:15326297). PA associated with LF forms the lethal toxin (LeTx) and causes death when injected; PA associated with EF forms the edema toxin (EdTx) and produces edema (PubMed:1651334). PA induces immunity to infection with anthrax (PubMed:11544370).
Specific Function
identical protein binding
Gene Name
pagA
Uniprot ID
P13423
Uniprot Name
Protective antigen
Molecular Weight
85810.325 Da

Drug created at May 11, 2015 18:08 / Updated at October 03, 2024 04:54