{"id":"rixubis-on-demand","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":"CHEMBL2048510","moleculeType":"Small molecule","molecularWeight":"276.38"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hemophilia B is caused by deficiency or dysfunction of coagulation Factor IX, a vitamin K-dependent serine protease essential for the intrinsic pathway of blood coagulation. RIXUBIS is a recombinant human Factor IX produced in Chinese hamster ovary cells that directly substitutes for the missing or defective endogenous factor, enabling the formation of the tenase complex and restoration of normal thrombin generation and clot formation.","oneSentence":"RIXUBIS is a recombinant Factor IX that replaces deficient or dysfunctional clotting factor IX to restore blood coagulation in patients with hemophilia B.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:05:34.661Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia B (Factor IX deficiency) — on-demand treatment and control of bleeding episodes"}]},"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":"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":192,"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: On-Demand","genericName":"RIXUBIS: On-Demand","companyName":"Baxalta now part of Shire","companyId":"baxalta-now-part-of-shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"RIXUBIS is a recombinant Factor IX that replaces deficient or dysfunctional clotting factor IX to restore blood coagulation in patients with hemophilia B. Used for Hemophilia B (Factor IX deficiency) — on-demand treatment and control of bleeding episodes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}