Humate-P®Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized
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 derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent, cannot be completely eliminated.
Possible adverse events include allergic reaction, urticaria, chest tightness, rash, pruritus, and edema. Anaphylactic reactions can occur in rare instances.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapy, especially in patients with known risk factors for thrombosis. In these patients, caution should be exercised and antithrombotic measures should be considered.
Full Prescribing Information for Humate-P
®