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| Primary information |
|---|
| ID | 11809 |
| Therapeutic ID | Th1256 |
| Protein Name | Coagulation Factor IX (Recombinant) |
| Sequence | >Th1256_Coagulation_Factor_IX_(Recombinant)
YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
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| Molecular Weight | 46548.2 |
| Chemical Formula | C2041H3136N558O641S25 |
| Isoelectric Point | 5.2 |
| Hydrophobicity | -0.431 |
| Melting point | 54 °C |
| Half-life | 18.8 ± 5.4 hours |
| Description | Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B). |
| 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. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients. |
| Mechanism of Action | Coagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the 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 | NA |
| Metabolism | NA |
| Absorption | NA |
| NA |
| Clearance | 8.62 ± 1.7 |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Coagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase |
| Brand Name | Rixubis |
| Company | Takeda |
| Brand Description | Takeda |
| Prescribed For | Intravenous |
| Chemical Name | 3000 unit / vial |
| Formulation | RIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS] |
| Physical Appearance | The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet. |
| Route of Administration | Rixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package.... |
| Recommended Dosage | Rixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications. |
| Contraindication | NA |
| Side Effects | RIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are: |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |