A database of FDA approved therapeutic peptides and proteins
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1839 details |
| Primary information | |
|---|---|
| ThPP ID | Th1228 |
| Therapeutic Peptide/Protein Name | Factor IX Complex (Human) |
| Sequence | NA view full sequnce in fasta |
| Functional Classification | Ib |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting Point (℃) | NA |
| Half Life | 11-28 hr |
| Description | Factor IX Complex is a sterile, lyophilized concentrate composed of a number of Vitamin K-dependent clotting factors found in functioning human plasma. Also known as prothrombin complex concentrate, products containing this complex often include Factor IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower Factor), and low levels of Factor VII (proconvertin) derived from human plasma. Many commercially available products also contain low levels of other antithrombotic proteins. For example, Kcentra (FDA) also contains the antithrombotic proteins C and S, while Bebulin VH (FDA) contains heparin. Coagulation factors are purified from pooled human plasma and subsequently sterilized and treated. Although Factor IX Complex products contain many different coagulation components, Factor IX is the lead component for potency and efficacy, particularly when used for the treatment of bleeding associated with Hemophilia B (Factor IX deficiency). As the product Kcentra, Factor IX Complex is also indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients experiencing acute major bleeding or requiring rapid reversal of therapy. |
| Indication/Disease | Factor IX Complex is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients. It is also indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or who require rapid reversal of therapy. |
| Pharmacodynamics | NA |
| Mechanism of Action | Factor IX is a vitamin K-dependent coagulation factor sythesized in the liver; purified FActor IX from human plasma temporarily replace missing clotting factor IX to correct and/or prevent bleeding. |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | NA |
| Volume of Distribution | NA |
| Clearance | NA |
| Categories | Antihemophilic agent |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Information of corresponding available drug in the market | |
| Brand Name | AlphaNine SD or Mononine |
| Company | |
| Brand Discription | It is a man-made protein that is similar to a natural protein in the body that helps the blood to clot. |
| Prescribed for | s used to treat or prevent bleeding in people with hemophilia B |
| Chemical Name | NA |
| Formulation | NA |
| Physcial Appearnce | Powder and solvent for solution for injection |
| Route of Administration | Intravenous |
| Recommended Dosage | AlphaNine SD, Mononine: 1 unit/kg x body wt (kg) x desired increase (% of normal) = Number of factor IX units required |
| Contraindication | |
| Side Effects | |
| Useful Link | http://www.rxlist.com/profilnine-drug.htm , https://www.drugs.com/monograph/factor-ix-human-factor-ix-complex-human.html ,https://en.wikipedia.org/wiki/Prothrombin_complex_concentrate, http://reference.medscape.com/drug/alphanine-mononine-factor-ix-342157#0 |
| PubMed ID | 26685667, 27546767, 27488143 |
| 3-D Structure | N.A. |