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ADYNOVATE twice-weekly prophylaxis prevented or reduced the number of bleeds 2
ADYNOVATE was proven in two pivotal clinical trials to prevent or reduce the number of bleeding episodes in children and adults when used regularly ( prophylaxis ) 2
• Children Under 12 Years : This study evaluated the efficacy of ADYNOVATE twice-weekly prophylaxis and determined the ability to treat bleeding episodes for 6 months in 66 children under 12 years old who received 40-60 IU / kg of ADYNOVATE prophylaxis treatment 2 – During the 6-month study in children under 12 , those receiving twice-weekly prophylaxis treatment experienced a median † overall ABR ‡ of 2.0 – 0 bleeds in 38 % ( 25 out of 66 patients ) during 6 months on twice-weekly prophylaxis
• Adolescents and Adults 12 Years and Older : This study evaluated the efficacy of ADYNOVATE in a 6-month study that compared the efficacy of a twice-weekly prophylactic regimen with on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes in 137 patients . These adolescents and adults were given either ADYNOVATE prophylaxis twice-weekly at a dose of 40-50 IU / kg ( 120 patients ) or on-demand treatment with ADYNOVATE at a dose of 10-60 IU / kg ( 17 patients ). The primary study goal was to compare ABR between the prophylaxis and on-demand treatment groups 2 – 95 % reduction in median overall ABR [ 41.5 median ABR with on-demand ( 17 patients ) vs 1.9 median ABR with prophylaxis ( 120 patients )] – 0 bleeds in 40 % ( 40 out of 101 per-protocol § patients ) during 6 months on twice-weekly prophylaxis
†
Median is defined as the middle number in a list of numbers arranged in numerical order .
‡
ABR = annualized bleed rate , the number of bleeds that occur over a year .
§
Per-protocol patients were assigned to the prophylactic group and treated with their originally assigned dose for the entire duration of the study .
ADYNOVATE Important Information
Indications and Limitation of Use ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes ADYNOVATE is not indicated for the treatment of von Willebrand disease .