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Recombinant Factor IX (recombinant + factor_ix)

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Medical Sciences100%

Selected Abstracts

Recombinant factor IX (BeneFix®) by adjusted continuous infusion: a study of stability, sterility and clinical experience

HAEMOPHILIA, Issue 2 2001
P. Chowdary
The safety and efficacy of adjusted continuous infusion (CI) of recombinant factor IX (FIX; BeneFix®) was assessed in vitro and in a clinical study. BeneFix® was reconstituted at 100 IU mL,1 with or without unfractionated heparin (4 U mL,1) and stored at either 4 °C or room temperature. Reconstituted BeneFix® retained at least 90% activity over 14 days if stored at 4 °C but stability was reduced at room temperature. BeneFix® reconstituted in a sterile pharmacy was free of bacterial contamination. Six patients with haemophilia B received seven CIs of BeneFix® to cover routine surgery and severe bleeding episodes. The CIs lasted between 3 and 10 days. In all cases, haemostasis was excellent and the desired therapeutic FIX level was easily maintained. No thrombotic episodes or inhibitor development occurred but two patients developed thrombophlebitis at the infusion site when heparin was not added to the infusion. BeneFix® is not currently licensed for CI and we suggest that studies to enable licensing should be established as soon as possible. [source]

Management of third molar removal with a single dose of recombinant Factor IX (BeneFIX) and local measures in severe haemophilia B

AUSTRALIAN DENTAL JOURNAL, Issue 3 2010
ID Hewson
Abstract Background:, Patients with inherited bleeding disorders have historically had factor cover for oral surgery. Factor support is expensive, time consuming and places the patient at a potential risk of blood-borne diseases. This case describes the use of a significant reduction in factor support for a severe haemophilia B patient having third molars surgically removed. Methods:, Local measures were used after a single preoperative dose of Factor IX to obtain good postoperative haemostasis. Results:, Excellent haemostasis was achieved using local measures of 5% tranexamic acid solution, Surgicel® and Monocryl® sutures after a single preoperative dose of Factor IX. Conclusions:, Oral surgery may be performed on patients with inherited bleeding disorders using minimal factors and local haemostatic measures. A study of this patient population has commenced at The Alfred Hospital. [source]

Recovery of recombinant factor IX determined in clinical practice

HAEMOPHILIA, Issue 3 2009
M. MARTORELL
First page of article [source]

Reformulated BeneFix®: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B

HAEMOPHILIA, Issue 3 2007
T. LAMBERT
Summary. BeneFix®, the only recombinant factor IX (FIX), has been reformulated. The reformulation involves a change in diluent and allows for more concentrated infusions of recombinant FIX. A double-blind, randomized, pharmacokinetic (PK) crossover study demonstrated that reformulated BeneFix was bioequivalent to original BeneFix and follow-up PK evaluation after 6 months of treatment demonstrated the PK stability of reformulated BeneFix after multiple exposures. Favourable efficacy and safety profiles, consistent with those already well-established for original BeneFix, were observed: 81.1% of haemorrhages resolved with only a single infusion; 85.3% of initial treatment response ratings were Excellent or Good; more than half of the subjects using reformulated BeneFix for routine prophylaxis (11 of 17, 64.7%) had no spontaneous haemorrhages during their 6,12 month course of prophylactic treatment, with an overall spontaneous bleeding rate of 0.72 year,1; and for the single surgical procedure (knee washing), treatment was rated Useful. In addition, there was no FIX inhibitor development, allergic-type manifestations, or thrombogenic complications with more than 1100 infusions (nearly 5.2 million IUs) administered in this trial. All efficacy and safety outcomes from this study were achieved with more concentrated recombinant protein infusions than that possible with original BeneFix, and utilization of the 2000 IU per vial dosage strength, newly introduced with the reformulated product, was high (>62%). The reformulation of BeneFix allows smaller delivery volumes and an increased choice of dosage strengths without altering the PK properties (including incremental recovery and half-life) or the established efficacy and safety profile of recombinant FIX. [source]

Recombinant factor IX (BeneFix®) by adjusted continuous infusion: a study of stability, sterility and clinical experience

HAEMOPHILIA, Issue 2 2001
P. Chowdary
The safety and efficacy of adjusted continuous infusion (CI) of recombinant factor IX (FIX; BeneFix®) was assessed in vitro and in a clinical study. BeneFix® was reconstituted at 100 IU mL,1 with or without unfractionated heparin (4 U mL,1) and stored at either 4 °C or room temperature. Reconstituted BeneFix® retained at least 90% activity over 14 days if stored at 4 °C but stability was reduced at room temperature. BeneFix® reconstituted in a sterile pharmacy was free of bacterial contamination. Six patients with haemophilia B received seven CIs of BeneFix® to cover routine surgery and severe bleeding episodes. The CIs lasted between 3 and 10 days. In all cases, haemostasis was excellent and the desired therapeutic FIX level was easily maintained. No thrombotic episodes or inhibitor development occurred but two patients developed thrombophlebitis at the infusion site when heparin was not added to the infusion. BeneFix® is not currently licensed for CI and we suggest that studies to enable licensing should be established as soon as possible. [source]