Advate

Each vial contains nominally 250, 500 IU human coagulation factor VIII (rDNA), octocog alfa.

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ADVATE is indicated in all age groups.

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.

Hypersensitivity to the active substance or to any of the excipients or to mouse or hamster proteins.

Hypersensitivity: Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. The product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Inhibitors: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay. In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Excipient related considerations: After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.
Effects on Ability to Drive and Operate Machinery: ADVATE has no influence on the ability to drive and use machines.

Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and breastfeeding only if clearly indicated.

Very Common (≥1/10): Factor VIII inhibition in previously untreated patients (PUPs).
Common (≥1/100 to <1/10): Headache, pyrexia.
Uncommon (≥1/1000 to <1/100): Influenza, laryngitis, factor VIII inhibition in previously treated patients (PTPs), lymphangitis, dizziness, dysgeusia, memory impairment, migraine, syncope, tremor, eye inflammation, palpitations, haematoma, hot flush, pallor, dyspnoea, abdominal pain upper, diarrhoea, nausea, vomiting, hyperhidrosis, pruritus, rash, urticaria, chest discomfort, chest pain, chills, feeling abnormal, peripheral oedema, vessel puncture site haematoma, coagulation factor VIII level decreased, haematocrit decreased, laboratory test abnormal, monocyte count increased, post procedural complication, post procedural haemorrhage, procedural site reaction.
Not known: Anaphylactic reaction, hypersensitivity, fatigue, injection site reaction, malaise.

No interaction studies have been performed with ADVATE.

Haemostatics

B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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