Table 1.
Guidelines for Dosage During the Efficacy Component of the Study Were Adapted According to the Core SmPC for Hemophilia A and VWD [CPMP/BPWG/1619/1999;CPMP/BPWG/278/02], as Well as the Data Collected from Previous Efficacy Clinical Studies in VWD28–30
| Indication | Dose (IU/kg bw) VWF:RCo | Dose Frequency | Target FVIII : C/VWF :RCo (%) |
|---|---|---|---|
| NSB events | 25–50 | Initial | VWF : RCo peak level >50%, FVIII : C >30% |
| 25 | Subsequent (every 12–24 h) | VWF : RCo/FVIII : C trough levels of >30% until bleeding stops (usually 2–4 days) | |
| Prophylaxis | 25–40 | 1–3 times weekly | Trough >1% |
| Prophylaxis for menorrhagia | 25–50 | On day 1, days 1 and 2, or days 1, 2 and 3 per cycle | VWF : RCo/FVIII : C peak levels >30% |
| Minor surgery | 60 | Daily | VWF : RCo/FVIII : C trough levels of >30% until healing is complete (usually 2–4 days) |
| Major surgery | 60–80 | Initial | VWF : RCo peak level >100%, FVIII : C >60% |
| 30–60 | Subsequent (every 12–24 h) | VWF : RCo/FVIII : C trough levels of >50% until healing is complete (usually 5–10 days) |
Notes: Reproduced with permission from Lissitchkov TJ, Buevich E, Kuliczkowski K, Stasyshyn O, Cerqueira MH, Klukowska A, Joch C, Seifert W, Pharmacokinetics, efficacy, and safety of a plasma-derived VWF/FVIII concentrate (Formulation V) for on-demand and prophylactic treatment in patients with von Willebrand disease (SWIFT-VWD study), Blood Coagul Fibrinolysis, 28, 2, 152–62,11 https://journals.lww.com/bloodcoagulation/pages/default.aspx
Abbreviations: bw, body weight; FVIII:C, factor VIII:coagulant activity; IU, international unit; NSB, nonsurgical bleeding; SmPC, summary of product characteristics; VWD, von Willebrand disease; VWF:RCo, von Willebrand factor:ristocetin cofactor.