BIOSTATE (Clotting Factor VIII Concentrate)
Indications for Use
Biostate is a lyophilised concentrate of human blood coagulation factor VIII and von Willebrand factor. It is used to treat patients with Haemophilia A and von Willebrand Disorder.
Biostate differs from the previous product (AHF) in that it is a higher purity product and has an additional viral inactivation step. The high purity of Biostate is achieved using selective precipitation techniques and a new chromatographic high-resolution gel filtration step. Two dedicated viral inactivation steps include solvent detergent treatment with tributyl phosphate and polysorbate 80 and dry heat treatment at 80ºC for 72 hours.
Each single pack contains one vial of Biostate, one ampoule of Water for Injections BP (WFI) and a Preparation Device. Biostate is currently available in a 250 IU and 500IU vial sizes.
Availability
Usually issued on an individual patient basis following approval by an ARCBS Haematologist /Medical Officer. Hospitals may request supplies for stock from ARCBS. The Haemophilia centres and ARCBS work closely together to optimise patient care.
Precautions
Development of factor VIII antibodies can occur in patients congenitally deficient in factor VIII.
Dosage and Administration
The dosage of Biostate varies from 10IU/kg for spontaneous minor bleeds up to 40-50IU/kg for major trauma or operative procedures.
The number of whole vials of Biostate reconstituted for administration should be the nearest whole number above the total number of IU required, divided by 250.
Refer to the current product information sheet for further information.
See also the published experience in VWD patients.