Factor viii

Intravenous
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A
Adult: Dosage requirement, frequency, and duration may vary according to individual factor VIII levels, location and extent of bleeding, patient condition, and type of preparation used. Generally, 1 IU/kg will increase circulating factor VIII levels by approx 2% of normal activity or 2 IU/dL. Recommended increments in Factor VIII levels: Mild to moderate haemorrhage including early haemarthrosis, muscle or oral bleeding: Increase to 20-40% of normal. May be given 12-24 hourly for at least 1 day. More serious haemorrhage or minor surgery: Increase to 30-60% of normal. May be given 12-24 hourly for 3-4 days or for at least 1 day until healing is achieved (minor surgery). Severe haemorrhage: Increase to 60-100% of normal. May be given 8-24 hourly until threat is resolved. Major surgery: Increase to 80-100% of normal. May be given 8-24 hourly, continue therapy for at least another 7 days to maintain a 30-60% factor VIII activity. Refer to individual product information for further dosing details.
Child: Dosage recommendation may vary among countries or individual products. Refer to specific product guidelines.
Reconstitution: Reconstitute dried concentrate with the provided diluent then gently swirl or rotate vial. Do not shake. Reconstitution and preparation may vary among individual products (refer to specific product guideline).

Intravenous
Prophylaxis in severe haemophilia A
Adult: For long-term prevention: Usual dose: 20-50 IU/kg at 2-3 day intervals. Shorter dosage intervals or higher doses may be required in some cases. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.
Child: Dosage recommendation may vary among countries or individual products. Refer to specific product guidelines.
Reconstitution: Reconstitute dried concentrate with the provided diluent then gently swirl or rotate vial. Do not shake. Reconstitution and preparation may vary among individual products (refer to specific product guideline).

Patient with existing CV risk factors; blood groups A, B, and AB. Pregnancy and lactation. Monitoring Parameters Monitor blood pressure and heart rate prior to and during IV administration; vital signs, cardiac and CNS status during and after infusion; antihaemophilic factor levels before and during treatment; coagulation status; factor VIII inhibitor development. Observe for signs and symptoms of intravascular haemolysis and falling haematocrit; bleeding, and hypersensitivity reactions.

Significant: Formation of neutralising antibodies or inhibitors; haemolytic anaemia, intravascular haemolysis, and decreased haematocrit (large or frequent doses in patients with A, B, or AB blood groups). Rarely, hypersensitivity or allergic reactions (e.g. angioedema, anaphylaxis, burning and stinging at infusion site, flushing, chills, generalised urticaria, headache, hypotension, hives, lethargy, restlessness, tachycardia, nausea, chest tightness, tingling, wheezing, dyspnoea, vomiting). Gastrointestinal disorders: Dysgeusia, diarrhoea, abdominal pain. General disorders and administration site conditions: Fever, malaise. Investigations: Abnormal LFT, increased blood creatinine phosphokinase. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Dizziness. Respiratory, thoracic and mediastinal disorders: Cough. Skin and subcutaneous tissue disorders: Erythema, pruritus, rash, hyperhidrosis.

Factor VIII is a protein required for clot formation and maintenance of haemostasis that may be derived from human plasma or recombinant sources. It acts as a cofactor for activated factor IX, increasing the conversion of factor X to activated factor X (factor Xa). Factor Xa converts prothrombin into thrombin, which converts fibrinogen into fibrin thus forming a clot. Synonym: antihaemophilic factor.
Excretion: Terminal elimination half-life: Approx 12 hours.

Intravenous: Store between 2-8°C or below 25°C. Do not freeze. Protect from light. Storage recommendations may vary among individual products. Refer to specific product guidelines.

Haemostatics