Identification

Summary

Raxibacumab is a monoclonal antibody used in conjunction with an antibacterial regimen to treat patients with inhalational anthrax caused by Bacillus anthracis and for prophylaxis of inhalational anthrax when appropriate.

Generic Name
Raxibacumab
DrugBank Accession Number
DB08902
Background

Raxibacumab is a human IgG1λ monoclonal antibody that binds the protective antigen (PA) component of B. anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system. FDA approved on December 14, 2012.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Structure
Db08902
Protein Chemical Formula
C6320H9794N1702O1998S42
Protein Average Weight
142844.5367 Da
Sequences
Not Available
Synonyms
  • PA mAb
  • Raxibacumab

Pharmacology

Indication

Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

Not Available

Mechanism of action

Raxibacumab is a monoclonal antibody that binds free PA with an affinity equilibrium dissociation constant (Kd) of 2.78 ± 0.9 nM. Raxibacumab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin. It does not have direct antibacterial activity.

TargetActionsOrganism
AProtective antigen
antibody
Bacillus anthracis
Absorption

Raxibacumab does not cross the blood-brain-barrier. When a single IV dose of 40 mg/kg was administered to healthy, male and female human subjects, the pharmacokinetic parameters are as follows: Cmax = 1020.3 ± 140.6 mcg/mL; AUCinf = 15845.8 ± 4333.5 mcg·day/mL. Bioavailability is also dependent on site of injection. When administered to the vastus lateralis, the bioavailability is 71-85%. When administered to the gluteus maximus, the bioavailability is 50-54%.

Volume of distribution

Steady state volume of distribution exceeded plasma volume. This suggests that there is some distribution into the tissues.

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Mean terminal elimination half-lives of raxibacumab are as follows: IM dose = 15-19 days; IV dose = 16-19 days

Clearance

Clearance values were much smaller than the glomerular filtration rate indicating that there is virtually no renal clearance of raxibacumab.

Adverse Effects
Adverseeffects
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Toxicity

The most frequently reported adverse reactions were rash, pain in extremity, pruritus, and somnolence.

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
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Raxibacumab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Raxibacumab.
AducanumabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Aducanumab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Raxibacumab.
AlirocumabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Alirocumab.
AmivantamabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Amivantamab.
AnifrolumabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Anifrolumab.
AnsuvimabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Anthrax immune globulin human.
Antilymphocyte immunoglobulin (horse)The risk or severity of adverse effects can be increased when Raxibacumab is combined with Antilymphocyte immunoglobulin (horse).
Interactions
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Food Interactions
No interactions found.

Products

Products2
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International/Other Brands
Abthrax (Human Genome Sciences Inc.)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
RaxibacumabInjection50 mg/1mLIntravenousEmergent Manufacturing Operations Baltimore Llc2012-12-14Not applicableUS flag
RaxibacumabInjection50 mg/1mLIntravenousHuman Genome Sciences, Inc.2012-12-142022-05-31US flag
RaxibacumabInjection50 mg/1mLIntravenousGlaxo Operations UK Ltd2016-03-232018-01-05US flag
RaxibacumabInjection50 mg/1mLIntravenousHuman Genome Sciences, Inc.2012-12-142018-08-13US flag
RaxibacumabInjection50 mg/1mLIntravenousGlaxo Operations UK Ltd2016-03-232018-01-05US flag

Categories

ATC Codes
J06BB18 — Raxibacumab
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
  • Gram-positive Bacteria

Chemical Identifiers

UNII
794PGL549S
CAS number
565451-13-0

References

General References
  1. Mazumdar S: Raxibacumab. MAbs. 2009 Nov-Dec;1(6):531-8. Epub 2009 Nov 29. [Article]
KEGG Drug
D05706
PubChem Substance
347910384
RxNav
1366567
ChEMBL
CHEMBL2108638
Drugs.com
Drugs.com Drug Page
Wikipedia
Raxibacumab
FDA label
Download (416 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentBacterial Infections1
4Not Yet RecruitingTreatmentBacterial Infections1
3CompletedTreatmentHealthy Subjects (HS)2
2, 3CompletedTreatmentTherapeutic Treatment of Inhalation Anthrax2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntravenous50 mg/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
isoelectric point9.0# Mazumdar S: Raxibacumab. MAbs. 2009 Nov-Dec;1(6):531-8. Epub 2009 Nov 29. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/20068396

Targets

Drugtargets2
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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 at June 10, 2013 06:08 / Updated at May 05, 2021 23:20