Pharmacokinetics, efficacy and safety of Humate-P® in von Willebrand disease

Authors


Dobrkovska Clinical Research & Development, Centeon Pharma GmbH, PO Box 1230, D-35002 Marburg, Germany. Tel:  + 49 6421 392738; Fax:  + 49 6421 393176.

Abstract

In a pharmacokinetic study with Humate-P® including six patients with various types of von Willebrand disease, a median half-life of 11.3 h for vWF:RCoF and of 15.2 h for vWF:Ag was found. The median value of in vivo recovery (IVR) was estimated for vWF:RCoF as 2.10 IU dL−1 plasma per 1 substituted IU kg−1 b.w. (or 73%), for vWF:Ag as 1.88 IU dL−1 plasma per 1 substituted IU kg−1 b.w. (or 69%); and for FVIII:C as 2.69 IU dL−1 plasma per 1 IU kg−1 b.w. (or 99%). Transient postinfusion shortening or normalization of previously prolonged bleeding time was observed in all patients. In a retrospective study involving 97 patients with various von Willebrand disease types, clinical efficacy and safety of treatment with Haemate-P® in 73 surgical interventions, 344 separate bleeding events, 93 other events and 20 cycles of prophylactic treatment were evaluated. The clinical efficacy was rated good to excellent in 99% of the surgeries, in 97% of the bleeding episodes, in 86% of the other events, and in all prophylactic treatments. The overall tolerability was good. Adverse events possibly or probably associated with use of Humate-P®/Haemate-P® were rare, of non-serious nature and mild to moderate in their intensity.

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