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RIXUBIS: Prophylaxis
Rixubis is a recombinant Factor IX (prothrombin complex component) that replaces deficient clotting factor to restore the intrinsic coagulation pathway.
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.
At a glance
| Generic name | RIXUBIS: Prophylaxis |
|---|---|
| Also known as | BAX326, Recombinant Factor IX, rFIX, Coagulation Factor IX [Recombinant], rFactor IX |
| Sponsor | Baxalta now part of Shire |
| Drug class | Recombinant coagulation factor |
| Target | Coagulation Factor IX (FIX) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- Prophylaxis of bleeding episodes in patients with hemophilia B (Factor IX deficiency)
- On-demand treatment of bleeding episodes in hemophilia B
Common side effects
- Inhibitor development (anti-Factor IX antibodies)
- Thrombotic events
- Injection site reactions
- Headache
- Fever
Key clinical trials
- RIXUBIS PMS India (RIXUBIS PMS) (PHASE4)
- ATHN 2: Factor Switching Study
- Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients (PHASE3)
- BAX 326 Pediatric Study (PHASE2, PHASE3)
- Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RIXUBIS: Prophylaxis CI brief — competitive landscape report
- RIXUBIS: Prophylaxis updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI