A database of FDA approved therapeutic peptides and proteins
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1627 details |
| Primary information | |
|---|---|
| ThPP ID | Th1138 |
| Therapeutic Peptide/Protein Name | Raxibacumab |
| Sequence | N.A. view full sequnce in fasta |
| Functional Classification | IIa |
| Molecular Weight | 142844.5367 |
| Chemical Formula | C6320H9794N1702O1998S42 |
| Isoelectric Point | N.A. |
| Hydrophobicity | N.A. |
| Melting Point (℃) | N.A. |
| Half Life | Elimnation half life-IM dose- 15-19 days; IV dose-16-19 days |
| Description | Recombinant (murine cell line derived), human IgG1 monoclonal antibody that binds the protective antigen (PA) component of B. anthracis toxin. FDA approved on December 14, 2012. |
| Indication/Disease | 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. |
| Pharmacodynamics | N.A. |
| 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. |
| Toxicity | The most frequently reported adverse reactions were rash, pain in extremity, pruritus, and somnolence. |
| Metabolism | N.A. |
| 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. |
| Clearance | Clearance values were much smaller than the glomerular filtration rate indicating that there is virtually no renal clearance of raxibacumab. |
| Categories | Anti-Infective Agents and Monoclonal antibodies |
| Patents Number | N.A. |
| Date of Issue | N.A. |
| Date of Expiry | N.A. |
| Drug Interaction | N.A. |
| Target | Protective antigen |
| Information of corresponding available drug in the market | |
| Brand Name | RAXIBACUMAB |
| Company | GSK |
| Brand Discription | Raxibacumab is a human IgG1λ monoclonal antibody that binds the 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. |
| Prescribed for | 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 |
| Chemical Name | N.A. |
| Formulation | Single-use vial contains 1700 mg/34 mL (50 mg/mL) raxibacumab solution. |
| Physcial Appearnce | Raxibacumab is supplied as a sterile, liquid formulation in single-dose vials for Intravenous infusion. Each vial contains 50 mg/mL raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), and sucrose (10 mg/mL), with a pH of 6.5. Eac |
| Route of Administration | N.A. |
| Recommended Dosage | Premedicate with diphenhydramine. Dilute and administer as an Intravenous infusion over 2 hours and 15 minutes. Adults: 40 mg/kg raxibacumab. Pediatrics greater than 50 kg: 40 mg/kg raxibacumab. Pediatrics greater than 15 kg to 50 kg: 60 mg/kg raxibacumab. Pediatrics 15 kg or less: 80 mg/kg raxibacumab. |
| Contraindication | There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs. Nursing Mothers: Caution should be exercised when administered to a nursing woman. Pediatric Use: Safety and effectiveness in children <16 years of age not studied. |
| Side Effects | Infusion reactions may occur. Premedicate with diphenhydramine. Slow or interrupt infusion and administer treatment based on severity of the reaction. Common adverse reactions in healthy adult subjects (≥1.5%) were: rash, pain in extremity, pruritus, and somnolence. |
| Useful Link | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htm, |
| PubMed ID | 25487792, 24812521, 23545582, 23344456, 20068396 |
| 3-D Structure | N.A. |