EFFICACY AND SAFETY OF MONOCLONAL-ANTIBODY PURIFIED FACTOR-IX CONCENTRATE IN HEMOPHILIA-B PATIENTS UNDERGOING SURGICAL-PROCEDURES

The present study summarizes results of the efficacy and safety of mon oclonal antibody (MAb) purified factor IX concentrate [Mononine(R) Coa gulation Factor IX (Human), Centeon L.L.C., King of Prussia, PA, USA] for surgical prophylaxis in 74 patients with mild, moderate or severe haemophilia B who underwent a total of 81 different operative interven tions. Surgical procedures included joint replacement/arthroplasty (n = 12), gastrointestinal (GI) or rectal surgery (n = 6), synovectomy/os teotomy (n = 8), hernia repair (n = 4), central catheter insertion (n = 3), ENT surgery (n = 4), dental procedures (n = 14), biopsies (n = 2 ), gynaecological procedures (n = 4), ophthalmological surgery (n = 4) , spinal surgery (n = 4), urogenital surgery (n = 2), other orthopaedi c surgery (n = 4) or other miscellaneous procedures (n = 10). All pati ents demonstrated haemostasis rated as 'excellent' by the investigator s. No patients experienced clinically evident thromboembolic complicat ions during treatment with MAb factor IX. These results, from a large and varied random group of patients, demonstrate that this highly puri fied factor IX concentrate is safe and effective for surgical prophyla xis in patients with haemophilia B, including those patients who have experienced thromboembolic complications during prior treatment with p rothrombin complex concentrates.