Active Ingredient: Coagulation factor VIII
Treatment of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 20 international units coagulation factor VIII per kilogram of body weight and 40 international units coagulation factor VIII per kilogram of body weight, once daily.
The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient´s clinical condition.
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1% to 2% of normal activity.
The required dose is determined using the following formula:
Required units = body weight (kg) x desired factor VIII rise (%) x 0.5
The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:
| Degree of haemorrhage/Type of surgical procedure | Factor VIII level required (%) | Frequency of doses (hours)/Duration of therapy (days) |
|---|---|---|
| Haemorrhage | ||
| Early haemarthrosis, muscle bleeding or oral bleeding | 20-40 | Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. |
| More extensive haemarthrosis, muscle bleeding or haematoma | 30-60 | Repeat every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved. |
| Life threatening haemorrhages | 60-100 | Repeat every 8 to 24 hours until threat is resolved. |
| Surgery | ||
| Minor surgery including tooth extraction | 30-60 | Every 24 hours, at least 1 day, until healing is achieved. |
| Major surgery | 80-100 (pre- and post-operative) | Repeat every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30-60%. |
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