About HUMATE-P

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About von Willebrand disease (VWD)

VWD is the most common bleeding disorder, affecting up to 1% of the US population, or about 3.2 million Americans. VWD occurs with equal frequency among men and women, although women tend to be diagnosed more often due to heavy or abnormal menstrual and/or postpartum bleeding.1

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What is HUMATE-P?

HUMATE-P is a human plasma–derived von Willebrand factor/factor VIII (VWF/FVIII) concentrate that is indicated for use in adults and pediatric patients with VWD for the treatment of spontaneous and trauma-induced bleeding episodes and the prevention of excessive bleeding during and after surgery. HUMATE-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD. HUMATE-P is also indicated for the treatment and prevention of bleeding in adults with hemophilia A.

Please see full prescribing information for HUMATE-P.
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What are the key benefits?

HUMATE-P has been studied for more than 30 years.

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#1 prescribed

HUMATE-P is the #1 prescribed VWF/FVIII concentrate treatment.2
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Reliable control

HUMATE-P provides reliable hemostatic control for all VWD types.
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Proven for all patient ages

HUMATE-P can be taken by infants, children, adolescents, and adults.

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Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P® 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. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with risk factors for thrombosis.

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

In patients receiving HUMATE-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions (reported by >5% of subjects) were allergic/anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis.

Please see full prescribing information.

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To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The information provided here is primarily intended for use by physicians and other healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.

References: 1. Centers for Disease Control and Prevention. What is von Willebrand disease? Reviewed April 1, 2021. Accessed March 24, 2022. https://www.cdc.gov/ncbddd/vwd/facts.html 2. Data on file. Available from CSL Behring as DOF HUM-002.

HUMATE-P is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

HUMATE-P® is a registered trademark of CSL Behring GmbH.

Driven by Our Promise™ is a trademark of CSL Behring LLC.

©2022 CSL Behring LLC. The product information presented on this page is intended for US residents only.

HUM-0041-AUG22

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