Raxibacumab
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
- 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.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prophylaxis of Inhalational anthrax •••••••••••• Used in combination to treat Inhalational anthrax •••••••••••• - Contraindications & Blackbox Warnings
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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.
Target Actions Organism AProtective antigen antibodyBacillus 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
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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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Raxibacumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Raxibacumab. Aducanumab The risk or severity of adverse effects can be increased when Raxibacumab is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Raxibacumab. Alirocumab The risk or severity of adverse effects can be increased when Raxibacumab is combined with Alirocumab. - Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- International/Other Brands
- Abthrax (Human Genome Sciences Inc.)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Raxibacumab Injection 50 mg/1mL Intravenous Emergent Manufacturing Operations Baltimore Llc 2012-12-14 Not applicable US Raxibacumab Injection 50 mg/1mL Intravenous Human Genome Sciences, Inc. 2012-12-14 2022-05-31 US Raxibacumab Injection 50 mg/1mL Intravenous Glaxo Operations UK Ltd 2016-03-23 2018-01-05 US Raxibacumab Injection 50 mg/1mL Intravenous Human Genome Sciences, Inc. 2012-12-14 2018-08-13 US Raxibacumab Injection 50 mg/1mL Intravenous Glaxo Operations UK Ltd 2016-03-23 2018-01-05 US
Categories
- ATC Codes
- J06BC02 — Raxibacumab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Anthrax Protective Antigen-directed Antibody
- Anthrax Protective Antigen-directed Antibody Interactions
- Antibacterial monoclonal antibodies
- Antibodies
- Antibodies, Monoclonal
- Antiinfectives for Systemic Use
- Blood Proteins
- Globulins
- Immune Sera and Immunoglobulins
- Immunoglobulins
- Immunoproteins
- Proteins
- Serum Globulins
- Specific Immunoglobulins
- 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
- Mazumdar S: Raxibacumab. MAbs. 2009 Nov-Dec;1(6):531-8. Epub 2009 Nov 29. [Article]
- External Links
- KEGG Drug
- D05706
- PubChem Substance
- 347910384
- 1366567
- ChEMBL
- CHEMBL2108638
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Raxibacumab
- FDA label
- Download (416 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Bacterial Infections 1 4 Not Yet Recruiting Treatment Bacterial Infections 1 3 Completed Treatment Healthy Volunteers (HV) 2 2, 3 Completed Treatment Therapeutic Treatment of Inhalation Anthrax 2
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intravenous 50 mg/1mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
Property Value Source isoelectric point 9.0 # 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
- 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