Active Ingredient: Susoctocog alfa
Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
200 - 200 [iU] per kg of body weight
From 200 To 200 [iU] per kg of body weight once every day
The dose, frequency, and duration of the therapy with susoctocog alfa depend on the location, extent and severity of the bleeding episode, target Factor VIII activity, and on the patient’s clinical condition.
The number of units of Factor VIII administered is expressed in Units (U) that are derived from an in-house standard that has been calibrated with the current WHO standard for Factor VIII products. One Unit (U) of Factor VIII activity is equivalent to that quantity of Factor VIII in one ml of normal human plasma.
The recommended initial dose is 200 U per kilogram bodyweight, given by intravenous injection. The required initial dose of susoctocog alfa for a patient is calculated using the following formula:
Initial dose (U/kg) / Product strength (U/vial) × Body weight (kg) = Number of vials
e.g. for a 70 kg subject the number of vials for an initial dose will be calculated as follows:
200 U/kg / 500 U/vial × 70 kg = 28 vials
Monitor Factor VIII activity and clinical condition 30 minutes after the first injection and 3 hours after administering susoctocog alfa.
Monitor Factor VIII activity immediately prior to and 30 minutes after subsequent doses and refer to the table below for recommended target Factor VIII trough levels. The one-stage clotting assay for Factor VIII is recommended as it has been used in determination of the potency of susoctocog άλφα and the mean recovery rate.
The dose and frequency of administration should be based on results of Factor VIII activity (to be maintained within recommended limits) and on the clinical response achieved.
Efficacy and safety data in patients with acquired haemophilia are limited.
| Type of Bleeding | Target Factor VIII Trough Activity (Units per dL or % of normal) | Initial Dose (Units per kg) | Subsequent Dose | Frequency and Duration of Subsequent Dosing |
|---|---|---|---|---|
| Mild and moderate superficial muscle / no neurovascular compromise and joint bleeding | >50% | 200 | Titrate subsequent doses based on clinical response and to maintain target Factor VIII trough activity | Dose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured Factor VIII activity |
| Major moderate to severe intramuscular, retroperitoneal, gastrointestinal, intracranial bleeding | >80% |
Once bleeding has responded, usually within the first 24 hours, continue susoctocog alfa with a dose that maintains the trough FVIII activity at 30-40% until bleeding is controlled. The maximum blood FVIII activity must not exceed 200%.
The length of treatment depends on clinical judgement.
The total volume of reconstituted susoctocog alfa should be administered at a rate of 1 to 2 mL per minute.
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