Publications

Presented here is a variety of books and articles of interest to healthcare professionals in the area of coagulation and bleeding disorders.

James, Andra H., 100 Questions & Answers about von Willebrand Disease (September, 2008). This guidebook provides a primer for patients and their families, and addresses questions and answers that help individuals better understand and cope with von Willebrand Disease (VWD). It includes current, practical, comprehensible information about types of VWD and how they affect the patient, as well as symptoms, diagnosis, treatment, and daily living.

Mauser-Bunschoten E.P., De Knecht-van Eekelen A., and Smit C. Aging with Hemophilia: Medical & Psychosocial Impact (2008). This book addresses the medical and social issues of aging hemophiliacs, including relationship of other diseases, avoiding complications, and recommendations and practical advice for daily living.

Budde U. et al. Seminars in Thrombosis & Hemostasis 2006;32:514–521. Comparative Analysis and Classification of VWF-FVIII Concentrates: Impact on Treatment of Patients with VWD. In this publication, Budde et al present a comparative study with 12 VWF/FVIII concentrates with focus on content, activities of FVIII and VWF and content of high molecular weight VWF multimers. Based on this analysis, the authors propose a classification of VWF/FVIII products.

Philipp C., Faiz A., Dowling N., et al. Obstet Gynecol, 2005. 105;61-66. Age and the prevalence of bleeding disorders in women with menorrhagia. In this paper, Philipp et al present a study to determine the frequency and types of hemostatic disorders on 115 women at different reproductive stages who suffer from unexplained menorrhagia.

Scharrer I. Hamostaseologie. 2004;24:44-49. Women with von Willebrand disease. In this publication, Scharrer reviews statistics on women who suffer from von Willebrand disease spanning all reproductive stages from the onset at the menarche, menorrhagia, pregnancy, post-partum period to menopause. The article also covers treatment options.

Gill J.C., Ewenstein B.M, Thompson A.R., Mueller-Velten G., Schwartz B.A. Haemophilia. 2003; 9:688-695. Successful treatment of urgent bleeding in von Willebrand disease with factor VIII/VWF concentrate (Humate-P®): Use of the ristocetin cofactor assay (VWF:RCo) to measure potency and to guide therapy. Gill et al. present prospective data on efficacy and biological recovery of VWF:RCo activity of Haemate P / Humate-P in 33 von Willebrand patients based on VWF:RCo activity, the accepted standard assay for measuring VWF activity. Patients either experienced urgent bleeding episodes or were undergoing urgent and necessary surgery.

Lillicrap D., Poon M-C., Walker I., Xie F., Schwartz B.A., and members of the Association of Hemophilia Clinic Directors of Canada. Thromb Haemost. 2002;87:224-230. Efficacy and safety of the Factor VIII/von Willebrand factor concentrate, Haemate-P/Humate-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. In this publication, the safety and efficacy of Haemate P/Humate-P was retrospectively assessed in 97 Canadian von Willebrand disease patients on the basis of ristocetin cofactor units (VWF:RCo). This is the first study to evaluate this product on the basis of VWF:RCo units, the most accepted and most specific method to measure VWF activity.

Metzner H.J., Hermentin P., Cuesta-Linker T., Langner S., Müller H-G., Friedebold J. Haemophilia. 1998;4(suppl 3): 25-32. Characterization of factor VIII/von Willebrand factor concentrates using a modified method of von Willebrand factor multimer analysis. For the analysis of von Willebrand concentrate quality, Metzner et al present a specific method to determine the high molecular weight multimers of VWF in different VWF/FVIII concentrates. Using this approach, the authors compared Haemate P/Humate-P to five other commercially available products.




Important Safety Information About Humate-P

Humate-P® Antihemophilic Factor/von Willebrand Factor Complex (Human) is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations, or to any of its components.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures considered.

Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most common adverse reactions reported in patients receiving Humate-P are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding.

Please see full prescribing information for Humate-P.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Last Updated: 5/19/2010 1:03 PM
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