Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
Refacto (Wyeth)
vials containing 250 IU, 500 IU and 1000 IU
Approved indication: haemophilia A
Australian Medicines Handbook Section 7.4
Patients with haemophilia A are at risk of having severe bleeding after minor trauma because they lack factor VIII. To prevent this bleeding, patients can be given an infusion of concentrated factor VIII. These concentrates are plasma products, so there is always a risk of transmitting infection. This led to the development of recombinant factor VIII.
Moroctocog is a genetically engineered factor VIII produced using Chinese hamster ovary cells. The production process differs from that of previously marketed recombinant products (Kogenate, Recombinate) as human albumin is not included in the final preparation.
The indications for moroctocog are similar to those of the other recombinant factor VIII products. It can be used to prevent or control surgical bleeding. Moroctocog can be given to patients who have developed neutralising antibodies, but higher doses may be required. The incidence of these antibodies following treatment is similar to that seen after treatment with the other factor VIII products.
If necessary, the activity of moroctocog can be measured. It is important to know which assay is used as one method will underestimate the activity.
