MONOFIX-VF

What it is

MonoFIX-VF is human coagulation factor IX. It is a sterile freeze-dried powder containing purified human coagulation factor IX. MonoFIX-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. The factor IX is purified using ion-exchange and heparin affinity chromatography to remove other vitamin K-dependent factors such as factors II, VII and X. MonoFIX-VF is presented in two different concentrations: 50 IU/mL and 100 IU/mL, and in three different presentations.

Approved indications

— Treatment of haemorrhages in patients with haemophilia B. — Use in surgery in patients with haemophilia B. — Prophylaxis in patients with haemophilia B.

Dosing overview

Dosage recommendations are general guidelines for therapy, and the exact loading and maintenance doses and dosing intervals should be based on the patient's clinical condition and response to therapy. Laboratory tests should be performed to ensure that the desired plasma factor IX concentrations are achieved.

Key safety warnings

High doses of prothrombin complex concentrates have been associated with disseminated intravascular coagulation (DIC). Although MonoFIX-VF contains purified factor IX, the potential risk of thrombosis and DIC should be recognised. The use of products containing factor IX could be hazardous in patients with a history of fibrinolysis, myocardial infarction, DIC or liver disease. The reported prevalence for the formation of neutralising antibodies (inhibitors) in patients receiving plasma-derived factor IX is approximately 4%, and patients should be monitored for the development of factor IX inhibitors. If the expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor IX inhibitor is present. In patients with high levels of inhibitor, factor IX replacement therapy may not be effective and other therapeutic options should be considered. This product is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically Creutzfeldt-Jakob Disease agents, that can cause disease. The manufacturing process includes a solvent detergent treatment and a nanofiltration step to reduce the possibility of virus transmission. MonoFIX-VF contains 50–140 IU heparin sodium in each 500 IU vial and 100–280 IU in each 1000 IU vial. Heparin is known to cause thrombocytopenia and this possibility should be considered if thrombocytopenia develops during treatment.

Contraindications

No contraindications are known.

Regulatory history

MonoFIX-VF was first listed on the Australian Register of Therapeutic Goods on 24 November 1998. Two additional presentations were registered on 31 May 2005.