Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1
PROTECTION FROM A SINGLE DOSE IN SURGERY1,a

In a clinical trial of adolescents and adults, Rebinyn® was shown to provide protection from a single dose on the day of surgery.1,a


PROTECTION FROM A SINGLE DOSE IN SURGERY1,a

In a clinical trial of adolescents and adults, Rebinyn® was shown to provide protection from a single dose on the day of surgery.1,a


IN ALL MAJOR SURGERIES STUDIED:1,a



pre-operative dose1




intraoperative success rate1


pre-operative dose1


intraoperative success rate1
aResults shown are from the major surgery trial, which included 13 previously treated adolescent and adult subjects. On the day of their respective surgeries, patients received 1 infusion of Rebinyn® 80 IU/kg. Postoperatively, subjects received infusions of Rebinyn® 40 IU/kg at the investigator’s discretion for up to 3 weeks after surgery. Across 13 surgical procedures (9 major)—which included 9 orthopedic, 1 gastrointestinal, and 3 oral cavity procedures—the hemostatic effect during surgery was evaluated on a 4-point scale of excellent, good, moderate, or poor. Treatment success was defined as excellent or good hemostasis.
FACTOR IX ACTIVITY SUSTAINED UP TO 48 HOURS POSTSURGERY1,2,b



bIn the surgery study, mean FIX activity following an initial preoperative Rebinyn® 80 IU/kg dose in 13 procedures was assessed by one-stage assay with product-specific standard. At 8 and 24 hours, one subject who had no FIX activity measurement obtained was excluded. At 48 hours, 2 subjects who had no FIX activity measurement obtained were excluded and 4 subjects re-dosed prior to the second day after surgery for whom FIX activity at 24 hours were 84%, 112%, 131%, and 134%. The FIX activity at 48 hours reflects a measurement on the second day after surgery (range 47-57 hours).
cRange shaded represents the normal population FIX activity range of 50% to 150%.
EFFECTIVE BLEED CONTROL

ESTABLISHED SAFETY PROFILE

Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1
EFFECTIVE BLEED CONTROL
Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1
ESTABLISHED SAFETY PROFILE
Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1
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