Factor concentrates

We work closely with Haemophilia Treatment Centres to support the management of patients with bleeding disorders due to deficiencies in coagulation factors. Hospitals may request the following coagulation factors from us:

Biostate® is a lyophilised concentrate of human coagulation factor VIII and von Willebrand factor (vWF).

Biostate® is used for the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von Willebrand Disease and occasionally patients with factor VIII deficiency due to haemophilia A. Biostate® is available in the following presentations:

  • 250 IU factor VIII / 500 IU vWF
  • 500 IU factor VIII / 1000 IU vWF
  • 1000 IU factor VIII / 2000 IU vWF

Biostate® product information

This link takes you to CSL Behring's web information about Biostate®. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy & lactation, adverse effects, and dosage & administration of Biostate®.

MonoFIX-VF® is a lyophilised concentrate of human coagulation factor IX and is used for the treatment of bleeding, for use in surgery, and as prophylaxis in patients with haemophilia B (congenital factor IX deficiency or Christmas disease).

MonoFIX-VF® is not indicated for the treatment of  factor II, VII or X deficiencies because it does not contain therapeutic levels of these factors or for treating haemophilia A patients with factor VIII inhibitors.

MonoFIX-VF® is available in three presentations: 500 IU (50 IU/ml), 500 IU (100 IU/mL) and 1000 IU (100 IU/mL).

MonoFIX-VF® product information

This link takes you to CSL Behring's web information about MonoFIX-VF®. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of MonoFIX-VF®.

Prothrombinex-VF® is a lyophilised concentrate of human coagulation factors containing factors II, IX and X and a small amount of factor VII.

Prothrombinex-VF® is used for 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 caused by vitamin K antagonists and requiring partial or complete reversal (eg. reversal of warfarin anticoagulant therapy).

Because of the potential risk of thrombosis Prothrombinex-VF® should not be used for prophylaxis or treatment of bleeding in patients with haemophilia B if a specific factor IX concentrate such as MonoFIX-VF® is available.

For warfarin reversal the Prothrombinex-VF® dose is 15–50 IU/kg depending on bleeding risk and initial INR (1).

Prothrombinex-VF® is available as a single vial containing 500 IU of factor IX, 500 IU of factor II and 500 IU of factor X.

Prothrombinex-VF® product information

This link takes you to CSL Behring's web information about Prothrombinex-VF®. You can download the product information (PI) sheet from this web page.

Information about the Mix2Vial can be found at Mix2Vial Information

The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Prothrombinex-VF®.
 

Thrombotrol-VF® is a lyophilised concentrate of human antithrombin (also known as antithrombin III or ATIII). It is used in the treatment of patients with inherited deficiency of antithrombin to provide prophylaxis and treatment of thrombosis and thromboembolism during surgery, pregnancy and childbirth.

It may also be indicated in cases of acquired antithrombin deficiencies such as liver disease and acute disseminated intravascular coagulation (DIC).

Thrombotrol-VF® is available in single vials nominally containing 1000 IU of antithrombin.

Thrombotrol-VF® product information

This link takes you to CSL Behring's web information about Thrombotrol-VF®. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, adverse effects, and dosage and administration of Thrombotrol-VF®.

Recombinant factor VIII

Recombinant products are available from us in NSW and SA.

Advate® is a lyophilised concentrate of recombinant factor VIII and is used for the control and prevention of bleeding episodes, perioperative management and prophylaxis in patients with haemophilia A.

Advate® does not contain von Willebrand Factor and should not be used in the treatment of patients with von Willebrand disease.

Advate® is available in the following presentations: 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU.

Advate® product information.

Baxalta Australia has advised that Advate® product information (PI) can be obtained by contacting their Customer Service or alternatively downloaded from the Baxalta US website.

Xyntha® is a lyophilised concentrate of recombinant coagulation factor VIII and is used for the control and prevention of bleeding episodes in patients with haemophilia A, including bleeding in surgical settings.

Xyntha® does not contain von Willebrand Factor and should not be used in the treatment of patients with von Willebrand disease.

Xyntha® is available in the following presentations: 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU

Xyntha® Product Information

Recombinant factor IX

Recombinant products are available from us in NSW and SA.

BeneFIX® is a lyophilised concentrate of recombinant coagulation factor IX and is used for the control and prevention of bleeding episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

BeneFIX is not indicated for the treatment of other factor deficiencies (eg. factors II, VII and X), the treatment of haemophilia A patients with inhibitors to factor VIII, the reversal of coumarin-induced anti-coagulation, or for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

BeneFIX® is available in the following presentations: 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU

BeneFIX® Product Information

Rixubis® is a lyophilised concentrate of recombinant factor IX and is used for the control and prevention of bleeding episodes, perioperative management and prophylaxis in patients with haemophilia B (congenital factor IX deficiency or Christmas disease).

Rixubis® is available in the following presentations: 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU.

Rixubis® product information.

Baxalta Australia has advised that Rixubis® product information (PI) can be obtained by contacting their Customer Service or alternatively downloaded from the Baxalta US website.

Always refer to and read the product information sheets  for further information on precautions, dosage and administration prior to giving coagulation factors.

Reference
  1. Tran HA, Chunilal SD, Harper PL, Tran H, Wood EM, Gallus AS. An update of consensus guidelines for warfarin reversal. MJA 2013;198(4):198-199.