{"id":"rixubis-prophylaxis","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (anti-Factor IX antibodies)"},{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"}]},"_chembl":{"chemblId":"CHEMBL2109205","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rixubis is a genetically engineered human coagulation Factor IX produced in Chinese hamster ovary cells. It functions as a replacement therapy for patients with Factor IX deficiency (hemophilia B), enabling the formation of the tenase complex and restoration of the intrinsic coagulation cascade to prevent and control bleeding episodes.","oneSentence":"Rixubis is a recombinant Factor IX (prothrombin complex component) that replaces deficient clotting factor to restore the intrinsic coagulation pathway.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:05:34.526Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prophylaxis of bleeding episodes in patients with hemophilia B (Factor IX deficiency)"},{"name":"On-demand treatment of bleeding episodes in hemophilia B"}]},"trialDetails":[{"nctId":"NCT03565237","phase":"PHASE4","title":"RIXUBIS PMS India (RIXUBIS PMS)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2018-12-07","conditions":"Hemophilia B","enrollment":25},{"nctId":"NCT02546622","phase":"","title":"ATHN 2: Factor Switching Study","status":"COMPLETED","sponsor":"American Thrombosis and Hemostasis Network","startDate":"2015-09","conditions":"Hemophilia","enrollment":310},{"nctId":"NCT01174446","phase":"PHASE3","title":"Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-07-29","conditions":"Hemophilia B","enrollment":86},{"nctId":"NCT01488994","phase":"PHASE2, PHASE3","title":"BAX 326 Pediatric Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-12-20","conditions":"Hemophilia B","enrollment":23},{"nctId":"NCT02190149","phase":"","title":"Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2014-07-22","conditions":"Hemophilia A, Hemophilia B","enrollment":64}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":682,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["BAX326","Recombinant Factor IX","rFIX","Coagulation Factor IX [Recombinant]","rFactor IX"],"phase":"marketed","status":"active","brandName":"RIXUBIS: Prophylaxis","genericName":"RIXUBIS: Prophylaxis","companyName":"Baxalta now part of Shire","companyId":"baxalta-now-part-of-shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"Rixubis is a recombinant Factor IX (prothrombin complex component) that replaces deficient clotting factor to restore the intrinsic coagulation pathway. Used for Prophylaxis of bleeding episodes in patients with hemophilia B (Factor IX deficiency), On-demand treatment of bleeding episodes in hemophilia B.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}