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Important Safety Information Prescribing Information To Healthcare Professionals Site

Why
HUMATE-P
Taking
HUMATE-P
Safety
Patient
Stories
Support
& Resources
About von Willebrand
Disease
- What Is VWD?
- Diagnosis &
  Treatment Options

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Why HUMATE-P
Taking HUMATE-P
Safety
Patient Stories
Support & Resources
About von Willebrand
Disease
- What Is VWD?
- Diagnosis &
  Treatment Options

To Healthcare Professionals Site

Important Safety Information

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.

You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958.

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HUMATE-P is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
HUMATE-P^® is a registered trademark of CSL Behring GmbH.
Mix2Vial^® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
HUMATE-P Connect^SM and CSL Behring Assurance^SM are service marks of CSL Behring LLC.

©2023 CSL Behring LLC. The product information presented on this site is intended for US residents only. USA-HUM-0002-NOV22

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