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• W2951243075 abstract "Abstract Introduction: Hemophilia is a bleeding disorder characterized by ineffective clot formation due to insufficient thrombin generation. Fitusiran is a subcutaneously (SC) administered investigational RNA interference (RNAi) therapeutic targeting antithrombin (AT) as a means to improve thrombin generation (TG) and promote hemostasis in patients with hemophilia A or B with and without inhibitors. Previously reported data have shown that monthly administration of fitusiran led to dose dependent AT lowering, improved thrombin generation and decreased bleeding frequency. (Pasi et al. Blood . 2016.; Pasi et al. New Engl J Med . 2017.) Data from an open-label extension study demonstrated an encouraging safety and tolerability profile, including when used in combination with factor or bypassing agents to treat breakthrough bleeds. (Pasi et al. Res Pract Thromb Haemost . 2017.) The management of operative procedures while on novel, non-factor therapies for hemophilia, such as fitusiran, is of clinical interest. The purpose of this abstract is to describe details as reported by study investigators on the perioperative hemostatic management during dental/surgical procedures in patients with hemophilia receiving fitusiran in a clinical trial. Methods: The fitusiran Phase 1 study (NCT02035605) followed by the Phase 2 open-label extension (OLE) study (NCT02554773) included patients with hemophilia A or B with and without inhibitors. After the Phase 1 dose-escalation study, patients eligible to continue dosing in the Phase 2 OLE received monthly, fixed SC doses of fitusiran, 50 mg or 80 mg. Data on perioperative hemostatic treatment and hemostatic response were collected for patients undergoing dental/surgical procedures while AT was lowered on study. Results: Four patients, ages 22-36, with severe hemophilia A (2 with inhibitors) underwent 5 surgical procedures: endoscopic cholecystectomy and septoplasty; thoracotomy/partial lung segmentectomy; molar teeth extraction; premolar tooth extraction. Prior to the procedures, the AT level for each of these patients was Conclusion: Successful perioperative hemostatic management of patients in the context of AT lowering with fitusiran has been observed; the number of dental/surgical procedures is limited and additional data are needed to further define appropriate perioperative hemostatic management plans. Disclosures Negrier: Baxter: Research Funding; Inspiration: Research Funding; LFB: Honoraria, Speakers Bureau; Octapharma: Honoraria, Research Funding, Speakers Bureau; CSL Behring: Honoraria, Research Funding, Speakers Bureau; Baxalta: Honoraria, Speakers Bureau; Pfizer: Honoraria, Research Funding, Speakers Bureau; Alnylam: Research Funding; Bayer: Honoraria, Research Funding, Speakers Bureau; Novo Nordisk: Honoraria, Research Funding, Speakers Bureau; Biogen/SOBI: Honoraria, Research Funding, Speakers Bureau. Ragni: Alnylam: Consultancy, Honoraria, Research Funding; Biomarin: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; MOGAM: Consultancy, Honoraria; Sangamo: Research Funding; Genentech/Roche: Research Funding; Bioverativ: Consultancy, Honoraria, Research Funding; NovoNordisk: Honoraria; SPARK: Research Funding; Shire: Consultancy, Honoraria, Research Funding. Georgiev: Alnylam: Consultancy. Van Nguyen: Alnylam: Employment, Equity Ownership. Madigan: Alnylam: Employment, Equity Ownership. Pasi: Bayer HealthCare; Biotest; Novo Nordisk; Pfizer Inc.; Roche: Speakers Bureau; Alnylam Pharmaceuticals, Inc; Biogen Idec Inc.; BioMarin Pharmaceutical Inc.; Octapharmal; Roche; Shire; SOBI: Consultancy; Pfizer, SOBI, Octapharma, Shire, Bayer, Alnylam, Biomarin, Biotest: Honoraria; Alnylam Pharmaceuticals; BioMarin Pharmaceutical Inc.; SOBI: Membership on an entity's Board of Directors or advisory committees; Roche, NovoNordisk, Pfizer: Other: paid instructor; BioMarin Pharmaceutical Inc.; Octapharma, Alnylam Pharmaceuticals, Bioverativ: Research Funding." @default.
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• W2951243075 date "2017-12-07" @default.
• W2951243075 modified "2023-09-28" @default.
• W2951243075 title "Perioperative Management in Patients with Hemophilia Receiving Fitusiran, an Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia" @default.
• W2951243075 doi "https://doi.org/10.1182/blood.v130.suppl_1.2366.2366" @default.
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