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The decision for an individual patient on the use of home treatment of bleeding and prophylaxis of bleeding in patients with hemophilia A should be made by the treating physician who should ensure that appropriate training is provided and the use is reviewed at intervals.
Posology: The dose and duration of the treatment depend on the severity of the factor VIII deficiency, the location and extent of the bleeding, and 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 standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).
Each vial label of AFSTYLA states the factor VIII potency in International Units (IU). One IU corresponds to the activity of factor VIII contained in one milliliter of normal human plasma.
Potency assignment is determined using a chromogenic substrate assay.
Plasma factor VIII levels can be monitored using either a chromogenic substrate assay or a one-stage clotting assay (see Precautions).
On demand treatment: Calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL. The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % of normal) is estimated using the following formula: (See Equation 1).
Click on icon to see table/diagram/imageThe dose to achieve a desired in vivo peak increase in factor VIII level may be calculated using the following formula: (See Equation 2).
Click on icon to see table/diagram/imageThe amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
A guide for dosing AFSTYLA for the control and prevention of bleeding episodes is provided in the following table. Consideration should be given to maintaining a factor VIII activity at or above the target range: (See Table 3).
Click on icon to see table/diagram/imageProphylaxis: The recommended starting regimen is 20 to 50 IU/kg of AFSTYLA administered 2 to 3 times weekly.
The regimen may be adjusted based on patient response.
Previously untreated patients: The safety and efficacy of AFSTYLA in previously untreated patients have not yet been established.
Pediatric population: The recommended starting regimen in children (0 to <12 years of age) is 30 to 50 IU per kg of AFSTYLA administered 2 to 3 times weekly. More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
For adolescents of 12 years of age and above, the dose recommendations are the same as for adults (see Pharmacology: Pharmacokinetics under Actions).
Geriatric population: Clinical studies of AFSTYL did not include subjects aged over 65 years.
Monitoring for inhibitors: Patients should be monitored for the development of factor VIII inhibitors. See also Precautions.
Method of administration: Intravenous use.
For instructions on reconstitution of the medicinal product before administration, see Precautions for disposal and other handling under Cautions for Usage. The reconstituted preparation should be injected slowly at a rate comfortable for the patient.
The patient should be observed for any immediate reaction. If any reaction takes place that might be related to the administration of AFSTYLA, the rate of injection should be decreased or the application should be stopped, as required by the clinical condition of the patient (see also Precautions).
