Von Willebrand Factor/Coagulation Factor VIII Complex (Human) (Wilate) is a lyophilized powder for solution for intravenous injection, indicated for adult and pediatric patients with von Willebrand disease and adults and pediatric patients 12 years of age and older with hemophilia A. Wilate was first approved in December of 2009, and most recently, in July 2026, the FDA expanded Wilate's von Willebrand routine-prophylaxis indication to include pediatric patients younger than 6 years. Wilate had previously been approved in December 2023 for routine prophylaxis in adults and pediatric patients 6 years of age and older. with von Willebrand disease.
Read on to learn more about Wilate, including its warnings and precautions, adverse reactions, dosage and administration information, and more.
Medication Overview:
- Brand Name: Wilate
- Generic Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)
- Indicated for: von Willebrand disease, hemophilia A
- Company: Octapharma
- Initial FDA Approval: December 2009
| Indicated Condition | Indication | Age | Initial Date Approved |
|---|---|---|---|
| von Willebrand Disease | Indicated in adult and pediatric patients with von Willebrand disease for on-demand treatment and control of bleeding episodes. | Adult and Pediatric Patients | December 2009 |
| von Willebrand Disease | Indicated in adult and pediatric patients with von Willebrand disease for perioperative management of bleeding. | Adult and Pediatric Patients | August 2015 |
| von Willebrand Disease | Indicated in adult and pediatric patients with von Willebrand disease for routine prophylaxis to reduce the frequency of bleeding episodes. | Adult and Pediatric Patients | December 2023 |
| Hemophilia A | Indicated in adult and pediatric patients 12 years of age and older with hemophilia A for on-demand treatment and control of bleeding episodes. | Adult and Pediatric Patients 12 Years and Older | October 2019 |
| Hemophilia A | Indicated in adult and pediatric patients 12 years of age and older with hemophilia A for outine prophylaxis to reduce the frequency of bleeding episodes. | Adult and Pediatric Patients 12 Years and Older | October 2019 |
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.
Dosage and Administration:
For intravenous use only.
Von Willebrand Disease
- Use the following formula to determine required dosage: Required IU = body weight (BW) in kg x desired VWF:RCo rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
- Adjust dosage depending on the severity of VWD, clinical condition and/or pharmacokinetic data. Additionally, for on-demand treatment, adjust dosage and duration based on location and extent of the bleeding.
- The recommended infusion rate is 2-4 mL/min.
On-demand treatment and control of bleeding episodes - Dosing Recommendations:
| Types of Bleeding Episodes | Loading Dosage (IU VWF:RCo / kg BW) | Maintenance Dosage (IU VWF:RCo / kg BW) | Therapeutic Goal |
|---|---|---|---|
| Minor Bleeding Episodes(patients age 6 and older) | 20-40 IU/kg | 20-30 IU/kg every 12-24 hours | VWF:RCo and FVIII activity trough levels of >30% |
| Major Bleeding Episodes(patients age 6 and older) | 40-60 IU/kg | 20-40 IU/kg every 12-24 hours | VWF:RCo and FVIII activity trough levels of >50% |
Perioperative management of bleeding - Dosing recommendations:
| Type of Surgery | Loading Dosage (IU VFW:RCo / kg BW) | Maintenance Dosage (IU VWF:RCo / kg BW) | Therapeutic Goal |
|---|---|---|---|
| Minor Surgeries(including tooth extractions) | 30-60 IU/kg | 15-30 IU/kg or half the loading dose every 12-24 hours for up to 3 days | VWF:RCo peak level of 50% after loading dose and trough levels of > 30% during maintenance doses |
| Major Surgeries | 40-60 IU/kg | 20-40 IU/kg or half the loading dose every 12-24 hours for up to 6 days or more | VWF:RCo peak level of 100% after loading dose and trough levels of > 50% during maintenance doses |
In order to decrease the risk of perioperative thrombosis, FVIII activity levels should not exceed 250%.
Routine prophylaxis to reduce the frequency of bleeding episodes - Dosing recommendations:
| Patients | Dose (IU/kg) | Frequency of Infusions |
|---|---|---|
| Age 6 and older | 20 – 40 IU/kg | Two or three times per week |
| Age <6 | 30 – 50 IU/kg | Two or three times per week |
Hemophilia A
- One International Unit (IU) of factor VIII (FVIII) activity per kg body weight increases the circulating FVIII level by approximately 2 IU/dL (1.7 IU/dL for adolescents and 2.3 IU/dL for adults).
- Use the following formula to determine required dosage: Required IU = body weight (BW) in kg x desired Factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
- The recommended infusion rate is 2-4 mL/min
- Dosing for on-demand treatment and control of bleeding episodes:
| Type of Bleeding Episodes | Recommended Dosage (IU/kg body weight) | Frequency of Doses (hours) | Duration of Therapy (days) |
|---|---|---|---|
| Minor | 30-40 | Repeat every 12-24 hours | At least 1 day, until the bleeding episode has resolved |
| Moderate | 30-40 | Repeat every 12-24 hours | 3 to 4 days or more, until the bleeding episode has resolved |
| Major | 35-50 | Repeat every 12-24 hours | 3 to 4 days or more, until the bleeding episode has resolved |
| Life-threatening | 35-50 | Repeat every 8-24 hours | Until threat has resolved |
Dosing for routine prophylaxis:
| Patients | Dose (IU/kg) | Frequency of Infusions |
|---|---|---|
| Adolescents and adults | 20-40 IU/kg | Every 2 to 3 days |
Individualize dosage based on the patient’s weight, type and severity of bleeding episode, FVIII level, presence of inhibitors and the patient’s clinical condition
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.
Adverse Reactions:
The most common adverse reactions (≥ 1%) in clinical trials on VWD were hypersensitivity reactions, urticaria, chest discomfort, and dizziness (6.1) The most common adverse reaction (≥ 1%) in clinical trials in hemophilia A was pyrexia (fever).
Related Guidelines
- Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System
- National Bleeding Disorders Foundation (NBDF)
- October 2024
- Management of Von Willebrand Disease
- American Society of Hematology (ASH), National Bleeding Disorders Foundation (NBDF), International Society on Thrombosis and Haemostasis (ISTH), World Federation of Hemophilia (WFH)
- January 2021
- Treatment of Congenital Hemophilia A and B
- International Society on Thrombosis and Haemostasis (ISTH)
- June 2024
Please note: This article is current as of August 20, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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