ASH Clinical News April 2016 | Page 24

Only with FEIBA prophylaxis Help stop his bleed before it starts 72% A clinical study showed* REDUCTION IN MEDIAN ANNUAL BLEED RATE1 28.7 median Annual Bleed Rate (ABR) with on-demand treatment1,2 629 bleeding episodes occurred during on-demand treatment1,2 7.9 median ABR with prophylaxis treatment1,2 196 bleeding episodes occurred during prophylaxis treatment1,2 *PROOF study: Phase 3, prospective, randomized, open-label study in 17 patients who received FEIBA prophylaxis (85 ± 15 U/kg every other day) and 19 patients who received FEIBA on-demand (dosages determined by treating physicians).1 Indications for FEIBA [Anti-Inhibitor Coagulant Complex] FEIBA is an Anti- Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Perioperative management • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. Detailed Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex] WARNING: THROMBOEMBOLIC EVENTS • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. • Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. The use of FEIBA is contraindicated in patients with: • Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system • Disseminated intravascular coagulation (DIC) • Acute thrombosis or embolism (including myocardial infarction) Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardialinfarction, and stroke) can occur with FEIBA, particularly following the administration of highdoses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.