Product Dossier
ADVATE
Product Dossier for ADVATE (Octocog alfa, Takeda Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Takeda Pharmaceuticals
- Active ingredient: Octocog alfa
- Therapeutic area: Haematology
- Related brand: KOVALTRY
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
ADVATE is octocog alfa, a recombinant coagulation factor VIII. It is produced from a genetically engineered Chinese Hamster Ovary cell-line under conditions which are free from the use of animal derived protein. Trehalose, a disaccharide stabiliser, has been used in the formulation instead of human albumin. The manufacturing process is free from the use of animal or human derived proteins, providing a low risk of transmission of blood-borne viruses derived from exogenous human and animal origins.
Approved indications
— Prevention and control of haemorrhagic episodes in haemophilia A. — Perioperative management in patients with haemophilia A.
Dosing overview
The dosage and duration of substitution therapy depend on the severity of factor VIII deficiency, the location and extent of the bleeding and on the patient's clinical condition. One IU of factor VIII per kilogram body weight raises the plasma factor VIII activity by 2 IU/dL.
Key safety warnings
ADVATE is not indicated for the treatment of von Willebrand's disease.
Regulatory history
ADVATE was first registered on the ARTG on 4 April 2005 in strengths of 250, 500, 1000 and 1500 IU. The 2000 IU strength was registered on 23 January 2008, the 3000 IU strength on 13 November 2008, and the 4000 IU strength on 16 July 2014.