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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 |
Results based on 50 PTPs <16 years of age with ≥20 previous exposure days with baseline FVIII activity of ≤2%. Of the 50 subjects <16 years of age who received at least 1 dose of XYNTHA, 38 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
Children (n=50) <16 years of age with severe or moderately severe hemophilia A (FVIII:C ≤2% and with ≥20 prior exposure days) received XYNTHA for on-demand and follow-up treatment. Results reported here for 38 patients (562 bleeding episodes). The median dose/infusion was 28 IU/kg. In comparison to the pharmacokinetic parameters reported in adults, children have shorter half-lives, larger volumes of distribution, and lower recovery of factor VIII after XYNTHA administration. Larger or more frequent doses may be required to account for the observed differences in pharmacokinetic parameters.
of bleed control ratings were excellent or good |
Perioperative management: Open-label study (n=30) for surgical prophylaxis in PTPs with severe or moderately severe hemophilia A (FVIII:C ≤2%) undergoing major surgical procedures. Results reported here for 25 patients who received XYNTHA replacement therapy for at least 6 days post surgery.
Rating scale:
Efficacy responses were assessed as follows: Excellent: Achieved hemostasis comparable to that expected after similar surgery in a patient without hemophilia. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared with that expected after similar surgery in a patient without hemophilia. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. None: No hemostatic response.
Physicians/surgeons rated the efficacy of XYNTHA in supporting the patient through the surgical procedure using the Surgical Hemostasis Efficacy rating scale at the end of surgery and at the end of the initial postoperative period for 25 patients: phase 3, open-label, multicenter, prospective study performed at a total of 13 study sites.
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 XYNTHA and XYNTHA SOLOFUSE.
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 XYNTHA and XYNTHA SOLOFUSE.
Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.
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