Treatment with XYNTHA should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Individual patients may vary in their response to factor VIII, achieving different levels of recovery and demonstrating different half-lives. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses or appropriate specific treatment may be required. Dosage adjustment for patients with renal or hepatic impairment has not been studied in clinical trials. XYNTHA is appropriate for use in adults and children. The required dosage is determined using the following formula: see equation.
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Dosing for bleeding and surgery: Minor:
20-40 IU/dL repeat every 12-24 hours as necessary, until resolved. At least 1 day, depending upon the severity of the hemorrhage; Moderate:
30-60 IU/dL repeat infusion every 12-24 hours for 3-4 days or until adequate wound healing (For tooth extraction, a single infusion plus oral antifibrinolytic therapy within 1 hour may be sufficient.); Major:
60-100 IU/dL repeat infusion every 8-24 hours until threat is resolved or until adequate wound healing in the case of surgery, then therapy for at least another 7 days.
Dosage for prophylaxis:
XYNTHA has been administered prophylactically in a pivotal clinical trial in adolescent and adult previously treated patients at a dose of 30 ± 5 IU/kg given 3 times weekly.