Raxibacumab

Identification

Name
Raxibacumab
Accession Number
DB08902  (DB05872)
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Description

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.

Protein structure
Db08902
Protein chemical formula
C6320H9794N1702O1998S42
Protein average weight
142844.5367 Da
Sequences
Not Available
Synonyms
  • PA mAb
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
RaxibacumabInjection50 mg/1mLIntravenousHuman Genome Sciences, Inc.2012-12-142018-08-13Us
RaxibacumabInjection50 mg/1mLIntravenousEmergent Manufacturing Operations Baltimore Llc2012-12-14Not applicableUs
RaxibacumabInjection50 mg/1mLIntravenousGlaxo Operations UK Ltd2016-03-232018-01-05Us
RaxibacumabInjection50 mg/1mLIntravenousGlaxo Operations UK Ltd2016-03-232018-01-05Us
RaxibacumabInjection50 mg/1mLIntravenousHuman Genome Sciences, Inc.2012-12-142022-05-31Us
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

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International/Other Brands
Abthrax (Human Genome Sciences Inc.)
Categories
UNII
794PGL549S
CAS number
565451-13-0

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.

Associated Conditions
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
Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Blackbox Warnings

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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.

Toxicity

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

Affected organisms
  • Gram-positive Bacteria
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.
AbituzumabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Abituzumab.
AbrilumabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Abrilumab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Raxibacumab.
AdecatumumabThe risk or severity of adverse effects can be increased when Adecatumumab is combined with Raxibacumab.
AducanumabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Aducanumab.
AfelimomabThe risk or severity of adverse effects can be increased when Afelimomab is combined with Raxibacumab.
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.
AmatuximabThe risk or severity of adverse effects can be increased when Raxibacumab is combined with Amatuximab.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

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  • Action
    Action

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Food Interactions
Not Available

References

General References
  1. Mazumdar S: Raxibacumab. MAbs. 2009 Nov-Dec;1(6):531-8. Epub 2009 Nov 29. [PubMed:20068396]
External Links
KEGG Drug
D05706
PubChem Substance
347910384
RxNav
1366567
ChEMBL
CHEMBL2108638
Drugs.com
Drugs.com Drug Page
Wikipedia
Raxibacumab
ATC Codes
J06BB18 — Raxibacumab
FDA label
Download (416 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2, 3CompletedTreatmentTherapeutic Treatment of Inhalation Anthrax2
3CompletedTreatmentHealthy Volunteers2
4CompletedTreatmentBacterial Infections1
4Not Yet RecruitingTreatmentBacterial Infections1

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

Taxonomy

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

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 June 10, 2013 00:08 / Updated on March 01, 2020 20:26

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