Humate-P®
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Humate-P
® is indicated (1) in adult patients for treatment and prevention of bleeding in hemophilia A (classical hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate.
- 2.4 ristocetin cofactor (RCo) international units per 1 antihemophilic factor international unit
- Presence of high molecular weight multimers of VWF
- Contains no preservatives
NDC Number |
Product Description |
| 0053-7615-05 | AHF/von Willebrand 600 RCo per vial |
| 0053-7615-10 | AHF/von Willebrand 1200 RCo per vial |
| 0053-7615-20 | AHF/von Willebrand 2400 RCo per vial |
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Use the unique Humate-P® Dosage Calculator, which makes individual dosing fast, easy and convenient. |
Important Safety Information
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 known risk factors for thrombosis.
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.
In patients receiving Humate-P® in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound and injection-site bleeding, and epistaxis.
The most commonly reported adverse reactions in patients receiving Humate-P® are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, or nosebleed.
Please see
full prescribing information.
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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.
Frequently Asked Questions for Humate-P®
To learn more about Humate-P® for the treatment of von Willebrand Disease (VWD), please visit www.Humate-P.com
Last Updated: 10 March 2010