octapharma
For the treatment of VWD

wilate®: Dosing

Convenient dosing interval: 12-24 hours

The balanced 1:1 ratio of VWF:RCo and FVIII:C in wilate® may help facilitate dosage calculation in VWD therapy, based on the declared units (vial sizes of 500 or 1000 IU). Thus, differentiation according to FVIII:C or VWF:RCo is not required.

In clinical trials demonstrating the efficacy of wilate® in the control of trauma induced/spontaneous bleeds, the dosing regimens shown in the table were used, which included convenient 12-24 hour dosing schedules. The dosage should be adjusted according to the extent and location of the bleeding. In VWD type 3 patients, especially in those with GI bleeds, higher doses may be required.1

Dosing for treatment of minor and major hemorrhages for all
VWD types1

Type of
hemorrhages
Loading dosage
(IU VWF:RCo/kg BW)
Maintenance dosage
(IU VWF:RCo/kg BW)
Therapeutic goal
Minor
hemorrhages
20-40 IU/kg
20-30 IU/kg
every 12-24 hours*
VWF:RCo and FVIII activity trough levels of >30%
Major
hemorrhages
40-60 IU/kg
20-40 IU/kg
every 12-24 hours*
VWF:RCo and FVIII activity trough levels of >50%

 *This may need to be continued for up to 3 days for minor hemorrhages and 5-7 days for major hemorrhages.

Physician supervision of the treatment regimen is required. The careful control of replacement therapy is especially important in life-threatening hemorrhages. When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII activity, which may increase the risk of thrombotic events.

Rapidly dissolved in a small injection volume, may help save time during administration.

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Dosing for treatment of minor and major surgeries in all
VWD types1

Type of
surgery
Loading dosage
(IU VWF:RCo/kg BW)
Maintenance dosage
(IU VWF:RCo/kg BW)
Therapeutic goal
Minor
(including tooth extraction)
30-60 IU/kg within 3 hours of the start of the surgical procedure
20-30 IU/kg or half the loading dose
every 12-24 hoursa-c
VWF:RCo peak level of 50% after loading dose and trough levels of >30% during maintenance doses until would healingd
Major
40-60 IU/kg within 3 hours of the start of the surgical procedure
20-40 IU/kg or half the loading dose
every 12-24 hoursa-c
VWF:RCo peak level of 100% after loading dose and trough levels of >50% during maintenance doses until wound healingd

a This may need to be continued for up to 3 days for minor surgeries and for 6 days or more for major surgeries (until wound healing is achieved).
b It is recommended to administer at least two maintenance doses within the first 24 hours after the start of the surgery.
c IVR and T1/2 for VWF:RCo/FVIII:C were 1.9% per IU/kg and 15.8 hours/2.2% per IU/kg and 19.6 hours, respectively.
d In order to decrease the risk of perioperative thrombosis, FVIII activity levels should not exceed 250%.

Indications and Usage

wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding. wilate® is not indicated for the treatment of hemophilia A.

Important Safety Information

wilate® is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container.

Hypersensitivity or allergic reactions have been observed upon use of wilate® and may in some cases progress to severe anaphylaxis (including shock) with or without fever.

When using a factor VIII (FVIII)-containing von Willebrand Factor (VWF) product, the treating physician should be aware that continued treatment may cause excessive rise in FVIII activity. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels, which may increase the risk of thrombotic events.

Patients with VWD, especially type 3 patients, may potentially develop neutralizing antibodies (inhibitors) to VWF, manifesting as an inadequate clinical response. Since inhibitor antibodies may occur concomitantly with anaphylactic reactions, patients experiencing an anaphylactic reaction should also be evaluated for the presence of inhibitors.

wilate® is made from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, eg, viruses and, theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent or other unknown infectious agents, cannot be completely eliminated. Despite measures to reduce this risk, such products may still potentially transmit disease.

The most common adverse reactions to treatment with wilate® in patients with VWD have been urticaria and dizziness. The most serious adverse reactions to treatment with wilate® in patients with VWD have been hypersensitivity reactions.

Please see full prescribing information.

To report suspected adverse reactions, contact:
Octapharma USA Inc.
866-766-4860 or
FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch

References

1. wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) full prescribing information. 2009.

Photos are of models and for illustrative purposes only.

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