Factor VIII: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A

Adult: Dosage is individualised based on coagulation tests performed before treatment and at regular intervals during treatment. Generally, 1 IU/kg will increase circulating factor VIII levels by about 2 IU/dL. Recommended doses vary according to the preparation used. Suggested doses: Mild-moderate haemorrhage (increase to 20-30% of normal): Usually with a single dose of 10-15 units/kg; more serious haemorrhage or minor surgery (increase to 30-50% of normal): Usual initial dose of 15-25 units/kg followed by 10-15 units/kg every 8-12 hr if required; severe haemorrhage or major surgery (increase to 80-100% of normal): Usual initial dose of 40-50 units/kg followed by 20-25 units/kg every 8-12 hr. Refer to individual product information for further dosing details.

Intravenous
Prophylaxis in severe haemophilia A

Adult: 10-50 u/kg every 2-3 days, as needed.

Reconstitution

Intravenous:
Treatment and prophylaxis of haemorrhagic episodes...: If refrigerated, warm dried concentrate and diluent to room temperature before reconstitution.

Special Precautions

Risk of intravascular haemolysis in patients with blood groups A, B, or AB receiving high doses or repeated doses of factor VIII preparations. Risk of transmission of some viral infections especially hepatitis B and C. Dose requirement may vary in patients with factor VIII inhibitors; thus optimal treatment should be based on clinical response. Monitor platelet counts regularly during treatment. Pregnancy, lactation.

Adverse Reactions

Allergic reactions e.g. chills, chest tightness, fever, headache, hyperfibrinogenaemia, jittery feeling, lethargy, nausea, vomiting, somnolence, stinging at infusion site, stomach discomfort, tingling, urticaria, vasomotor reactions with rapid infusion.

Pregnancy Category (US FDA)

IV/Parenteral: C

Action

Description: Factor VIII is required for clot formation and maintenance of haemostasis. It activates factor X in conjunction with activated factor IX. Activated factor X then converts prothrombin to thrombin, which converts fibrinogen to fibrin, and forms a stable clot with factor XIII. Factor VIII is used for replacement therapy in patients with haemophilia A.
Pharmacokinetics:
Excretion: Terminal half-life of about 12 hr.

Storage

Intravenous:
Treatment and prophylaxis of haemorrhagic episodes...: Store between 2-8°C. Use within 3 hr of reconstitution; do not refrigerate after reconstitution due to risk of precipitation.

MIMS Class

Haemostatics

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