Humate-P® von Willebrand Disease Dosage Calculator
This unique Humate-P® Dosage Calculator makes individual dosing fast,
easy, and convenient. The calculator determines the correct Humate-P®
loading dose (as measured in VWF:RCo units) needed to achieve the desired increase
in circulating VWF, as defined in the product prescribing information. (For guidance
on loading dose recommendations, please refer to Table 11 of the PI). All subsequent
doses should be based on patient response and measured levels of VWF:RCo and FVIII.
These calculations are to be used only with Humate-P® and are applicable
for the treatment of VWD and for the prevention of excessive bleeding during and
after surgery in all VWD types.
Humate-P® VWD Dosage Calculator
Instructions: To determine the Humate-P® dose (as measured in
VWF:RCo units) needed to achieve the target level of circulating VWF:
1) Enter the patient's body weight (BW) in kilograms (kg) OR pounds (lb)
2) Enter the patient's baseline level (BL) of VWF:RCo (measured as IU VWF:RCo/dL)
3) Enter the patient's target level (TL) of VWF:RCo (measured as IU VWF:RCo/dL)
4) Enter the patient's in vivo recovery (IVR). IVR is measured as rise in IU/dL
per IU/kg administered. If unknown, please click on the link next to the IVR field
and a value of 2 IU/dL will be used as the default per the dosage instructions in
the product prescribing information.
Based on the following formula, your patient's Humate-P dose is
VWF:RCo
units.
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[TL (IU/dL) - BL (IU/dL)] x BW (kg)
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=
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IVR (IU/dL)/(IU/kg)
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[ __ (IU/dL) - __ (IU/dL)] x __ (kg)
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= __ VWF:RCo units
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(IU/dL)/(IU/kg)
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A full chart of the Humate-P® VWD Dosage
Calculator is also available. General Rule: Doses are calculated based on an expected
in vivo recovery of 2.0 IU/dL rise in VWF:RCo activity per every IU/kg of VWF:RCo
administered.
Important Safety Information
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 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 (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, and epistaxis (nosebleed).
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.
The information provided herein is solely for use by physicians and 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.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.