A database of FDA approved therapeutic peptides and proteins
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1453 details |
| Primary information | |
|---|---|
| ThPP ID | Th1083 |
| Therapeutic Peptide/Protein Name | Coagulation factor ix |
| Sequence | YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQ view full sequnce in fasta |
| Functional Classification | Ia |
| Molecular Weight | 46548.2 |
| Chemical Formula | C2041H3136N558O641S25 |
| Isoelectric Point | 5.2 |
| Hydrophobicity | -0.431 |
| Melting Point (℃) | 54 |
| Half Life | 19.4 ± 5.4 hr (range 11-36 hr) |
| Description | Coagulation Factor IX (Recombinant) is a glycoprotein with an approximate molecular mass of 55,000 Da consisting of single chain of 415 amino acids. Sequence is identical to the A148 allelic form of plasma-derived factor IX. |
| Indication/Disease | For treatment of hemophilia (Christmas disease). |
| Pharmacodynamics | Binds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. |
| Mechanism of Action | Coagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting. Factor IX is plays an important intermediate role in the blood coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting. |
| Toxicity | N.A. |
| Metabolism | N.A. |
| Absorption | N.A. |
| Volume of Distribution | N.A. |
| Clearance | N.A. |
| Categories | Coagulants and Thrombotic Agents |
| Patents Number | N.A. |
| Date of Issue | N.A. |
| Date of Expiry | N.A. |
| Drug Interaction | N.A. |
| Target | N.A. |
| Information of corresponding available drug in the market | |
| Brand Name | Alprolix |
| Company | Biogen Idec Inc., and Genentech USA, Inc |
| Brand Discription | Coagulation Factor IX (Recombinant), Fc Fusion Protein [rFIXFc], the active ingredient in ALPROLIX, is a fully recombinant coagulation Factor IX protein consisting of the human coagulation Factor IX sequence covalently linked to the Fc domain of human immunoglobulin G1 (IgG1). The Factor IX portion of rFIXFc has a primary amino acid sequence that is identical to the Thr148 allelic form of plasma derived Factor IX and has structural and functional properties similar to endogenous Factor IX. The Fc domain of rFIXFc contains the hinge, CH2, and CH3 regions of IgG1. rFIXFc contains 867 amino acids with a molecular weight of approximately 98 kilodaltons. ALPROLIX is not derived from human blood and contains no preservatives. The recombinant Factor IX Fc fusion protein is expressed in a human embryonic kidney (HEK) cell line, which produces rFIXFc into a defined cell culture medium that does not contain proteins derived from animal or human sources. The purification process for rFIXFc does not include use of a monoclonal antibody reagent. To enhance viral safety, the purification process incorporates a nanofiltration step and a column chromatography purification step that have been validated for viral clearance. The content of activated Factor IX Fc fusion protein (FIXaFc) is limited to ≤ 0.035 mole percent FIXaFc/FIXFc. |
| Prescribed for | adults and children with hemophilia B (congenital Factor IX deficiency) for: Control and prevention of bleeding episodes, Perioperative management, Routine prophylaxis to prevent or reduce the frequency of bleeding episodes |
| Chemical Name | Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived |
| Formulation | After reconstitution, the solution has a clear to slightly opalescent appearance and contains the excipients: sucrose, mannitol, sodium chloride, L-histidine and polysorbate 20. ALPROLIX is available in single-use vials containing the labeled amount of Factor IX activity, expressed in international units. Each vial contains nominally 500 IU, 1000 IU, 2000 IU or 3000 IU. |
| Physcial Appearnce | ALPROLIX is a Sterile, non-pyrogenic, preservative-free, white to off-white, lyophilized powder to cake for reconstitution with the provided diluent, for Intravenous infusion |
| Route of Administration | Intravenous |
| Recommended Dosage | 30-100 IU/dL depending on intensity of bleeding |
| Contraindication | ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B . ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing clots/ |
| Side Effects | hives; difficulty breathing; swelling of your face, lips, tongue, or throat. |
| Useful Link | http://www.alprolix.com/ http://www.rxlist.com/alprolix-drug.htm http://www.drugs.com/mtm/coagulation-factor-ix.html |
| PubMed ID | 25213132, 24947827, 24832133, 24680550 |
| 3-D Structure | Th1083 (View) or (Download) |