Dosing and Usage
Dosing Overview1
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.
wilate Dosing for Routine Preventive Care in Hemophilia A
| Recommended Dosage (IU*/kg body weight) | Frequency of Infusions |
|---|---|
| 20-40 IU/kg | Every 2 to 3 days |
*IU = International Unit
On-Demand Treatment of Hemorrhages
Recommended dosing regimen for on-demand treatment of bleeds is outlined in the below table.
wilate Dosing for Treatment of Hemorrhages in Hemophilia A
| Type of Hemorrhage | 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 hemorrhage has resolved |
| Moderate | 30 – 40 | Repeat every 12 – 24 hours | 3 to 4 days or more, until the hemorrhage has resolved |
| Major | 35 – 50 | Repeat every 12 – 24 hours | 3 to 4 days or more, until the hemorrhage has resolved |
| Life Threatening | 35 – 50 | 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
Vial Sizes1
wilate Dosing for Routine Prophylaxis in Hemophilia A
| wilate vial sizes |
|---|
| 500 IU VWF:RCo and 500 IU FVIII activities in 5 ml |
| 1000 IU VWF:RCo and 1000 IU FVIII activities in 10 ml |
- Rapidly dissolved in a small injection volume — to help save time during administration
- Includes the Mix2Vial™ transfer device — a quick and easy way to mix wilate with less risk of accidental sticks
- Infusion rate of 2 to 4 mL/minute
Proper storage of wilate1
- Store wilate for up to 36 months in a refrigerator (+2°C to +8°C or 36°F to 46°F) protected from light, from the date of manufacture
- Within this period, wilate may be stored up to 6 months at room temperature (maximum of +25°C or 77°F)
- Once stored at room temperature, wilate must not be returned to the refrigerator
References:
- wilate Full Prescribing Information. Paramus, NJ: Octapharma; rev December 2023.