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.
On demand treatment: The required dose is determined using the following formula: Required international units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5.
Depending on the degree of haemorrhage or type of surgical procedure, the FVIII level should not fall under specified plasma activity levels, and the frequency of doses and duration of therapy have to be adjusted accordingly as per the SmPC guidance. The dose and frequency of administration should also be adapted to the clinical response in the individual case. Under certain circumstances (e.g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.
Prophylaxis: For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Paediatric population: For on demand treatment dosing in paediatric patients (0 to 18 years) does not differ from adult patients. In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended for prophylactic therapy.
ADVATE should be administered via the intravenous route. The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 mL/min.
Sign Out