Factor XI replacement for inherited factor XI deficiency in routine clinical practice: results of the HEMOLEVEN prospective 3‐year postmarketing study

• DOI: 10.1111/hae.12655
• Publication Date: 2015-03-27T07:39:09Z
• Authors: F. Bauduer; E. de Raucourt; C. Boyer‐Neumann; M. Trossaert; P. Beurrier; A. Faradji; J. Peynet; J.‐Y. Borg; P. Chamouni; C. Chatelanaz; C. Henriet; F. Bridey; J. Goudemand
• Keywords: Postmarketing surveillance; Factor XI

Factor XI (FXI)-deficient patients may develop excessive bleeding after trauma or surgery. Replacement therapy should be considered in high-risk situations, especially when FXI levels are below 20 IU dL(-1) . HEMOLEVEN is a human plasma-derived factor concentrate available France since 1992, but there few data regarding its use by physicians. This prospective study assessed the use, efficacy and safety of common clinical practice. was evaluated FXI-deficient 13 French centres 3-year postmarketing study. Forty-four (30 females, 14 males) received 67 treatments. The median age 37 years (8 months-91 years). Basal were <1 to 51 (median: 5.5); 29 severely (<20 ). administered prophylactically before 43 surgical procedures, 10 invasive 8 vaginal deliveries, as curative treatment for six bleeds. excellent/good 63, moderate two undetermined Seven experienced seven adverse effects, including rated serious: one sudden massive pulmonary embolism with fatal outcome case inhibitor FXI. effective prevention deficiency. However, considering benefit/risk ratio observed relation dosage this study; firstly, it used sparingly due potential prothrombotic effect; secondly, new prescription procedures defined adapt dosage, intrinsic and/or acquired risk factors thrombosis.