Proven Across All von Willebrand Disease Types

Whether you need it for bleeding episodes, emergency treatment, or are undergoing surgery, Humate-P is proven effective across all von Willebrand disease (VWD) types, including Type 3—the most severe form of VWD.1-4

Humate-P is also proven effective across multiple types of bleeds,1-4 including:

  • Spontaneous bleeding episodes2 (bleeding that occurs without an obvious cause or after an injury, such as nosebleeds)
  • Trauma-induced bleeding episodes1,2 (bleeding caused by accidents or injuries)
  • Bleeding occurring before and after surgery3,4

Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is approved to treat and prevent bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P also treats spontaneous or trauma-induced bleeding episodes in adults and children with von Willebrand disease (VWD) and prevents excessive bleeding during and after surgery in patients with mild, moderate or severe VWD. Humate-P is not known to prevent spontaneous bleeding episodes.

Do not take Humate-P if you have had extreme sensitivity or an allergic response to antihemophilic or von Willebrand factor preparations. Your doctor will monitor you for events related to abnormal blood clotting.

Humate-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.

In studies, more than 5% of patients reported the following adverse reactions to Humate-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds.

Please see full prescribing information.

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.

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© CSL Behring 2018. The product information on this site is intended for US residents only. HUM / 10-11-0010(1) 8/2015

References

  1. Gill JC, Ewenstein BM, Thompson AR, Mueller-Velten G, Schwartz BA, for the Humate-P Study Group. 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. Haemophilia. 2003;9(6):688-695.
  2. Lillicrap D, Poon M-C, Walker I, Xie F, Schwartz BA, and members of the Association of Hemophilia Clinic Directors of Canada. 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. Thromb Haemost. 2002;87(2):224-230.
  3. Lethagen S, Kyrle PA, Castaman G, Haertel S, Mannucci PM, for the Haemate P Surgical Study Group. von Willebrand factor/factor VIII concentrate (Haemate P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery. J Thromb Haemost. 2007;5(7):1420-1430.
  4. Thompson AR, Gill JC, Ewenstein BM, Mueller-Velten G, Schwartz BA; Humate-P Study Group. Successful treatment for patients with von Willebrand disease undergoing urgent surgery using factor VIII/VWF concentrate (Humate-P). Haemophilia. 2004;10(1):42-51.