PROTHROMBINEX – VF (Human Prothrombin Complex)
Indications for Use
Prothrombinex-VF is indicated in the prophylaxis and treatment of bleeding in patients with single or multiple congenital deficiencies of factor II or X and in patients with single or multiple acquired prothrombin complex factor deficiency requiring partial or complete reversal (e.g. reversal of warfarin anticoagulant therapy).
Because of the potential risk of Prothrombinex-VF induced thrombosis, Prothrombinex-VF should not be used for prophylaxis or treatment of haemorrhage in patients with haemophilia B if a highly-purified factor IX preparation such as MonoFIX-VF is available.
Contraindications
Prothrombinex-VF is contraindicated in patients showing clinical or laboratory signs of thrombosis or disseminated intravascular coagulation (DIC).
Availability
Hospitals may request supplies for stock from ARCBS. The Haemophilia centre and ARCBS work closely together to optimise patient care.
Prothrombinex-VF is currently available in 500IU vial size.
Precautions
- Thromboembolism: patients receiving Prothrombinex-VF (especially at dose levels greater than 5,000 IU of factor IX, or repeated doses), may be predisposed to venous thrombosis, arterial thromboembolism, DIC or myocardial infarction.
- Development of factor IX antibodies can occur in patients congenitally deficient in factor IX.
- Effect of heparin: As each vial of Prothrombinex contains 200 IU of heparin, consideration should be given to the clinical effect of heparin if thrombocytopenia develops, if high doses of Prothrombinex-VF are required or if used during pregnancy/lactation.
Dosage and Administration
The dosage of Prothrombinex-VF varies from 20-30 IU/kg for minor haemorrhage up to 50 IU/kg for moderate to severe haemorrhage. The exact loading and maintenance doses and dosing intervals should be based on the patient's clinical condition, response to therapy and relevant laboratory tests.
Refer to the current product information sheet for further information.
Refer to the consensus guidelines published by ASTH on use of PTX in warfarin reversal available here.
Click here to view CSL's FAQ sheet (PDF)