Bleeding 1 dose per day 1-2 per day 1 per day 1 per two days (minor treatment (minor except for life and moderate bleeding) threatening bleeding) bleeding (13 1-2 per day After 6-10 h then every per day) (moderate to 24 h (major bleeding) severe bleeding) Surgical Loading dose 1-2 per day 1 per day 1 per one-two days prophylaxis then 1-2 per (minor) (minor) day 1-3 per day After 6-10 h then every (major) 24 h (major) Routine Twice weekly Two to three Twice weekly Weekly (50 IU/kg) or prophylaxis times per every 10-14 days (100 week IU/kg) The general approach is to modify dosage regimens (for example dosage intervals, based on individual factors. Romiplostim, aflibercept, etanercept and abatacept are examples of registered products that are fusion proteins combining the Fc fragment of IgG1 and another active molecule. Long plasma residency time is one purported advantage of such peptibodies (peptide plus antibody). Alprolix for control and prevention of haemorrhagic episodes in patients with “the haemophilia B (congenital factor IX deficiency or Christmas disease), including the control and prevention of bleeding in surgical settings.” was granted orphan drug status by the TGA on 20 September 2012. Eftrenonacog alfa is referred to as rFIXFc in this AusPAR. Regulatory status Alprolix received initial registration on the Australian Register of Therapeutic Goods (ARTG) on 1 May 2014. At the time this application was considered by the TGA, similar applications had been submitted to the USA (December 2012), Canada (March 2013), Japan (September 2013) and South Africa (December 2013), and were planned for New Zealand (2014) and the European Union (in 2015). Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent Product Information please refer to the TGA website at <>.
Bleeding treatment 1 dose per day (minor bleeding) 1-2 per day (moderate to severe bleeding) 1-2 per day 1 per day except for life threatening bleeding (13 per day) 1 per two days (minor and moderate bleeding) After 6-10 h then every 24 h (major bleeding) Surgical prophylaxis Loading dose then 1-2 per day 1-2 per day 1 per day (minor) 1-3 per day (major) 1 per one-two days (minor) After 6-10 h then every 24 h (major) Routine prophylaxis Twice weekly Two to three times per week Twice weekly Weekly (50 IU/kg) or every 10-14 days (100 IU/kg) The general approach is to modify dosage regimens (for example dosage intervals, based on individual factors. Romiplostim, aflibercept, etanercept and abatacept are examples of registered products that are fusion proteins combining the Fc fragment of IgG1 and another active molecule. Long plasma residency time is one purported advantage of such peptibodies (peptide plus antibody). Alprolix for “the control and prevention of haemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including the control and prevention of bleeding in surgical settings.” was granted orphan drug status by the TGA on 20 September 2012. Eftrenonacog alfa is referred to as rFIXFc in this AusPAR. Regulatory status Alprolix received initial registration on the Australian Register of Therapeutic Goods (ARTG) on 1 May 2014. At the time this application was considered by the TGA, similar applications had been submitted to the USA (December 2012), Canada (March 2013), Japan (September 2013) and South Africa (December 2013), and were planned for New Zealand (2014) and the European Union (in 2015). Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent Product Information please refer to the TGA website at <>.
auspar-eftrenonacog-alfa-141103.docx