Established Safety Profile

The safety of ADYNOVATE® was evaluated in children and adults with severe hemophilia A who received at least 1 dose of ADYNOVATE in 3 completed, multicenter, prospective, open-label clinical studies and 4 ongoing clinical studies.¹

• In the adult and children over 12 study, 8 previously treated patients (negative at screening) developed transient lgG antibodies against FVIII (n=5) or PEG-FVIII (n=3) at 1 or 2 consecutive study visits.¹
• In the study of children under 12, 5 pediatric previously treated patients^† developed IgG antibodies against PEG-FVIII: transiently (n=2), binding antibodies at the completion of the study (n=2), and developed binding antibodies during the study and positive at completion with decreasing titer (n=1). For all 3 subjects who developed binding antibodies, no conclusion can be drawn whether these antibodies are of transient or persistent nature.^1,3
• One pediatric previously untreated patient from an ongoing study, who received at least one infusion of ADYNOVATE, developed neutralizing antibodies to FVIII.¹

*Inhibitors defined as ≥0.6 BU using the Nijmegen modification of the Bethesda assay.³
†Pediatric previously treated patients defined as: <6 years of age with ≥50 EDs, ≥6 to <12 years of age with ≥150 EDs.¹