Intended for US Healthcare Professionals Only

VWD Dosing Guidelines
Hemophilia A Dosing Guidelines

VWD Dosing Guidelines

wilate® is indicated in adult and pediatric patients with von Willebrand disease (VWD) for on-demand treatment and control of bleeding episodes; for perioperative management of bleeding; and for routine prophylaxis to reduce the frequency of bleeding episodes. The balanced physiological 1:1 ratio of VWF and FVIII in wilate® facilitates dosing and monitoring.*

The recommended dosages are:

On-Demand Treatment

Type of Hemorrhage Loading Dosage (IU VWF:RCo/kg Body Weight) Maintenance Dosage (IU VWF:RCo/kg Body Weight) Frequency Duration
Minor 20-40 20-30 Every 12-24 hours as needed Up to 3 days
Major 40-60 20-40 Every 12-24 hours as needed Up to 5-7 days

Major and Minor Surgeries

Type of Hemorrhage Loading Dosage (IU VWF:RCo/kg Body Weight) Maintenance Dosage (IU VWF:RCo/kg Body Weight) Frequency Duration
Minor 30-60 15-30 or half the loading dose 12-24 hours Up to 3 days
Major 40-60 20-40 or half the loading dose 12-24 hours Up to 6 days or more

Routine Prophylaxis

Patients Dose (IU/kg) Frequency
Age 6 and older 20-40 2-3 times per week
Age <6 30-50 2-3 times per week

For detailed dosage guidelines, see the full prescribing information for wilate® here.

Hemophilia A Dosing Guidelines1

wilate® is also indicated in adult and pediatric patients 12 years of age and older with hemophilia A for on-demand treatment and control of bleeding episodes; and for routine prophylaxis to reduce the frequency of bleeding episodes.

Dose and duration of therapy depend on the patient’s weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors.

Dose and frequency are adjusted according to the patient’s clinical response, individual needs, severity of deficiency, severity of hemorrhage, desired FVIII level, and presence of inhibitor, as well as the patient’s clinical condition.

Patients may vary in their pharmacokinetic (e.g., rate of absorption, bioavailability, distribution, metabolism, and excretion) and clinical responses to wilate®.

Routine Prophylaxis (Preventive Care)

Exact dosing should be defined by the patient’s clinical status and response.

Recommended Dosage

Every 2 – 3 days

*IU = International Unit

On-Demand Treatment of Hemorrhages

Recommended dosing regimen for on-demand treatment of bleeds is outlined in the table below.

Minor

30 – 40 (IU/kg)

Repeat every 12 – 24 hours for at least 1 day, until the hemorrhage has resolved

Moderate

30 – 40 (IU/kg)

Repeat every 12 – 24 hours for 3 to 4 days or more, until the hemorrhage has resolved

Major

35 – 50 (IU/kg)

Repeat every 12 – 24 hours for 3 to 4 days or more, until the hemorrhage has resolved

Life Threatening

35 – 50 (IU/kg)

Repeat every 8 – 24 hours until threat has resolved

The physician may adjust the dose and management plan according to the extent and location of bleeding and the patient’s clinical condition.

See Dosage and Administration, section 2.1 of full Prescribing Information.

Monitoring Parameters

Plasma FVIII levels should be monitored periodically to evaluate individual patient response to the dosage regimen

If dosing studies have determined that a particular patient exhibits a lower/higher than expected response and shorter/longer half-life (the amount of time it takes for the concentration of a drug in the body to be reduced to 50%), the dose and the frequency of dosing should be adjusted accordingly

Failure to achieve the expected FVIII:C (coagulant activity) level or to control bleeding after an appropriately calculated dosage may indicate the development of an inhibitor (an antibody to FVIII:C). The inhibitor level should be quantified by appropriate laboratory procedures and its presence documented. Treatment with wilate® in such cases must be individualized.

Please see full Prescribing Information for complete information on wilate® dosing

Two wilate® Vial Sizes to Support Individual Dosing Needs

For your convenience and to best meet your particular dosage requirements, wilate® is available in vials of 500 IU and 1000 IU. Each vial contains von Willebrand factor and factor VIII in a 1:1 ratio*.

500 IU VWF:RCo and 500 IU FVIII activities in 5 ml

1000 IU VWF:RCo and 1000 IU FVIII activities in 10 ml

*Based on von Willebrand factor and factor VIII activity levels.

How to Store wilate®1

Refrigerate for up to 36 months.

Refrigerate for up to 36 months from the date of manufacture, at 36ºF to 46ºF and protected from light.
or
Store for up to 6 months from the date of manufacture, at room temperature (below 77ºF).

Do not freeze

Do not freeze.

Do not use past expiration date

Do not use beyond the expiration date printed on the carton and bottle.

Once stored at room temperature, wilate® must not be returned to the refrigerator.

Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].

Please see wilate® full Prescribing Information.

Indication

wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in adult and pediatric patients with von Willebrand disease for on-demand treatment and control of bleeding episodes; for perioperative management of bleeding; and for routine prophylaxis to reduce the frequency of bleeding episodes. wilate® is also indicated in adult and pediatric patients 12 years of age and older with hemophilia A for on-demand treatment and control of bleeding episodes; and for routine prophylaxis to reduce the frequency of bleeding episodes.

Contraindications

Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container.

Warnings and Precautions

  • Anaphylaxis and severe hypersensitivity reactions are possible
  • Thromboembolic events may occur. Monitor plasma levels of FVIII activity
  • Neutralizing antibodies (inhibitors) to VWF and Factor VIII have occurred following administration of wilate®. Test for neutralizing antibodies if plasma VWF and/or Factor VIII level fail to increase as expected or if bleeding is not controlled after wilate® administration
  • wilate® is made from human plasma and carries the risk of transmitting infectious agents

Adverse Reactions

The most common adverse reactions (≥ 1%) in clinical trials on VWD were hypersensitivity reactions, urticaria, chest discomfort, and dizziness. The most common adverse reaction (≥ 1%) in clinical trials in hemophilia A was pyrexia (fever).

Please see wilate® full Prescribing Information.

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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

The information on this website has been specifically created 
for U.S. healthcare professionals (HCPs)

Please see wilate® full Prescribing Information