Haemate P/Humate-P: a systematic review.

Haemate P/Humate-P, the first plasma-derived von Willebrand factor (VWF)/factor VIII (FVIII)-containing concentrate that was pasteurized to reduce the risk of virus infection, was developed in the 1970s and approved for use in Germany in 1981. Today, Haemate P is marketed in over 35 countries worldwide for on-demand treatment and long-term prophylaxis in patients with von Willebrand disease (VWD) or haemophilia A. With more than 25 years of clinical experience, Haemate P has demonstrated predictable pharmacokinetics, consistent haemostatic efficacy, and an excellent safety profile in paediatric and adult populations. Its VWF composition is quantitatively and qualitatively similar to that of normal plasma. The risk of virus transmission has been minimized, and treatment-related adverse events are rare. Only a very low incidence of thromboembolic events has been reported. Guidelines for dosing have been developed; optimal dosing depends on the goals of therapy, clinical setting, VWD type and severity, and other patient-related factors. Based on the extensive clinical experience with Haemate P, it has become the gold standard for replacement therapy in patients with VWD. Further studies will continue to explore its use in other clinical settings, including as immune tolerance induction therapy for patients with haemophilia A.