About Humate-P

A VWF/FVIII treatment that's bringing results in VWD

Maybe you've just been prescribed Humate-P. Maybe you're just exploring treatment options. Whatever the reason, by choosing to learn more about Humate-P, you've taken a big step toward treating and managing von Willebrand disease (VWD) :

What is Humate-P?

Humate-P falls into a category of VWD treatments that are called von Willebrand factor/factor VIII (VWF/FVIII) replacement therapies.

  • These replacement therapies provide concentrated von Willebrand factor (VWF) to supplement or replace the VWF that is missing from your body.
  • By restoring VWF, replacement therapies such as Humate-P may help stop excessive bleeding, which may help you lead a more active, normal life.

Why Humate-P?

You can rely on Humate-P—the most prescribed and most tested VWF/FVIII replacement treatment with a long history of treatment.1,2

Preferred by more physicians and patients.

Humate-P is the most prescribed VWF/FVIII concentrate treatment.1,2

  • Extensive clinical experience
  • Long record of success

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Proven across all VWD types

Humate-P provides reliable hemostatic control for all VWD types across a broad range of clinical applications.

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Purified to high safety standards

CSL Behring's Integrated Safety System helps the product meet high quality and safety standards, thus reducing the risk of virus transmissions. The risk of virus transmission cannot be completely eliminated.

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Convenient dosing and administration

Humate-P is available in a variety of vial sizes. This may help make accurate dosing easier, reduce waste, and make vials easier to store and carry.

Before reconstitution, Humate-P can be safely stored at room temperature (25°C [77°F]) for up to 36 months*. (After reconstitution, Humate-P should be used within 3 hours.)

  • Humate-P comes with a packaging tray that
    • Helps hold vials in place while you're mixing to help make reconstitution easier
    • Is made of recyclable material
    • Protects vials in transit

Humate-P is indicated in adult and pediatric patients with 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 includes high-quality VWF and a high quantity of VWF relative to Factor VIII, which is important in the effective treatment of VWD.

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. Data on File. Available from CSL Behring as DOF HUM-001.
  2. 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.