Safety and Efficacy of B-domain Deleted Third Generation Recombinant Factor VIII (GreenGene F™) in Korean Patients with Hemophilia A: Data from a Post-marketing Surveillance Study

• DOI: 10.3346/jkms.2018.33.e5
• Publication Date: 2017-12-01T03:44:36Z
• Authors: Soon Ki Kim; Ki Young Yoo; Kun Soo Lee; Taiju Hwang; Yong Mook Choi; Eun Jin Choi; Sang Kyu Park
• Keywords: Postmarketing surveillance

New B-domain deleted third generation recombinant factor VIII (FVIII; GreenGene F™, beroctocog alfa) was launched in 2010. We determined safety and efficacy of F™ during routine clinical practice patients with hemophilia A over a period 12 months. From July 2010 to 2014, total 136 were enrolled post-marketing surveillance (PMS) study. Among them, 134 assessed for drug 114 analyzed efficacy. Patients differing severities medical histories monitored months prophylactic and/or on-demand therapy. evaluated, 85 (63.4%) had severe hemophilia. Ninety-two received 1,266,077 units prophylaxis, 42 516,491 bleeding episodes. Three developed inhibitors. In 112 previously treated patients, one patient (0.9%) inhibitor after intensive FVIII treatment surgery. 22 untreated inhibitors observed 2 infants (9.1%). Overall, there 47 adverse events (other than inhibitors) all types 30 (22.4%), 11 10 (7.5%) which considered showing serious (SAEs); most hemorrhages at different sites. None the SAEs judged as product related. An excellent/good rate 91.3% hemostasis 89.4% hemorrhage prevention recorded. The results this PMS study support use safe efficacious A. These are consistent findings from published studies.