J Korean Med Sci.  2018 Jan;33(1):e5. 10.3346/jkms.2018.33.e5.

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

• Kim SK
• Yoo KY
• Lee KS
• Hwang T
• Choi YM
• Choi EJ
• Park SK

• KMID: 2399162
• DOI: http://doi.org/10.3346/jkms.2018.33.e5

Abstract

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

Keyword

Recombinant Factor VIII; Hemophilia A; Previously Treated Patients; Previously Untreated Patients; GreenGene F; Beroctocog Alpha

MeSH Terms

Factor VIII*
Hemophilia A*
Hemorrhage
Hemostasis
Humans
Infant
Factor VIII