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Dosing
Octaplex
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octaplex® dosing and treatment duration depend on the severity of the disorder and the location and extent of bleeding; it should be controlled using regular measurements of plasma coagulation factors of interest or global tests of the prothrombin complex (prothrombin time, INR), with continuous monitoring of the patient’s clinical condition.
Dosage intervals must be adapted to the plasma half-life of different coagulation factors:
(factor II, 48–60 hours; factor VII, 1.5–6 hours; factor IX, 20–24 hours; factor X, 24–48 hours).
Bleeding and perioperative prophylaxis of bleeding during VKA treatment
The dose will depend on the INR before treatment and body weight. In the following table approximate doses (units/kg body weight of the reconstituted product) are given.
Pre-treatment INR | 2-< 4 | 4-6 | > 6 |
|---|---|---|---|
Dose of octaplex (units†of Factor IX) / kg body weight | 25 | 35 | 50 |
†Units refer to International Units.
Bleeding and perioperative prophylaxis in congenital deficiency of factors II and X
when specific coagulation factor product is not available.
Dosage for treatment should be individually calculated for each patient based on the empirical finding that approximately 1 IU of factor II or X per kg body weight raises the plasma factor II or X activity by 0.02 and 0.017 IU/mL, respectively.
One IU of a coagulation factor activity is equivalent to the quantity in 1 mL of normal human plasma.
The required dosage of factor X is calculated using the following formula:
Required units = body weight (kg) × desired factor X rise (IU/mL) × 60a
The required dosage of factor II is determined using the following formula:
Required units = body weight (kg) × desired factor II rise (IU/mL) × 50a
a60/50 (mL/kg) is the reciprocal of the estimated recovery; if the individual recovery is known, that value should be used for calculation.
Clinical Guidelines
On Bleeding Management
References:
SPC
