Humate-P^®

Antihemophilic Factor/von Willebrand Factor Complex (Human)

Q. Does the Humate-P^® stopper contain any latex?

A. The stoppers for Humate-P^® and the diluent do not contain latex. They are made from synthetic rubber. In addition, the 20-micron filter needle that is supplied does not contain latex.

Q. What size filter is provided with Humate-P^®?

A. The filter needle provided with Humate-P^® has a 20-micron pore size.

Q. Can Humate-P^® that has recently expired still be used?

A. The potency of Humate-P^® can only be assured through the expiration date on the vial.

Q. How should Humate-P^® be stored?

A. When stored at refrigerator temperature, 2-8°C (36-46°F), Humate-P^® is stable for the period indicated by the expiration date on the label. Within this period, Humate-P^® may be stored at room temperature not to exceed 30°C (86°F) for up to 6 months. Avoid freezing to prevent damage to the diluent bottle.

Q. How should Humate-P^® be dosed using the ristocetin cofactor units?

A. The dosage of Humate-P^® required (IU VWF:RCo) = body wt. (kg) x desired % increase in VWF activity ÷ 1.5. As a rule, 40-80 IU VWF:RCo per kg body weight are given every 8-12 hours. The dose should be adjusted according to the type of VWD and the extent and location of the bleed.

Q. Is Humate-P^® approved for the treatment of von Willebrand disease?

A. Yes. Humate-P^® is the only factor concentrate that is FDA-approved for the treatment of von Willebrand disease. It is also indicated for the treatment of hemophilia A.

Q. Is Humate-P^® virally inactivated?

A. Humate-P^® is pasteurized, heating in aqueous solution at 60°C for 10 hours. This method of viral inactivation has demonstrated reduction of both lipid-enveloped viruses (such as hepatitis B and C, HIV, and herpes viruses) and certain non-lipid-enveloped viruses (such as hepatitis A, parvo B19, and polio) in validation experiments. In over 15 years, and more than 475 million units infused, there have been no confirmed reports of viral transmissions with Humate-P^®. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Q. How soon after reconstitution must Humate-P^® be administered?

A. Humate-P^® does not contain a preservative. Therefore, to assure product sterility,
Humate-P^® should be administered within 3 hours after reconstitution.

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.