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of bleeds were controlled successfully on demand with 1 or 2 infusions
Rating scale:
Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. Moderate: Probable or slight improvement starting within 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.
Study design
Open-label study of PTPs (mean age, 27.7 years; range, 12-60 years) with severe or moderately severe hemophilia A (FVIII:C ≤2%; ≥150 previous exposure days) given XYNTHA 3 times per week (30 ± 5 IU/kg; N=94) and on demand (investigator-determined dose; n=53 [187 bleeding episodes]). Results reported here for 3-times-per-week administration are based on 89 patients accruing ≥50 exposure days to XYNTHA.
of bleeds were controlled successfully with 1 or 2 on-demand infusions
Results based on 18 PTPs 12 to <17 years of age with ≥150 previous exposure days with baseline FVIII activity of ≤2%. Of the 18 subjects <17 years of age who received at least 1 dose of XYNTHA, 10 subjects had bleeding episodes during the study.
Rating scale:
Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. Moderate: Probable or slight improvement starting within 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.
Study design
The open-label study of PTPs included 18 adolescents, 12 to <17 years of age who received XYNTHA for on-demand and follow-up treatment. Results reported here for 10 patients (66 bleeding episodes). The median dose/infusion was 47 IU/kg.
of bleeds were controlled successfully with 1 or 2 infusions
of bleed control ratings were excellent or good
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Please see full Prescribing Information for XYNTHA and XYNTHASOLOFUSE.
XYNTHA® Antihemophilic Factor (Recombinant) is indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.
XYNTHA is not indicated in patients with von Willebrand’s disease.
Please see full Prescribing Information for XYNTHAand XYNTHA SOLOFUSE.