Product Dossier
DEFERASIROX-TEVA
Product Dossier for DEFERASIROX-TEVA (deferasirox, Teva Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Teva Pharma
- Active ingredient: deferasirox
- Therapeutic area: Haematology
- Related brand: JADENU
- Related brand: EFERAS
- Related brand: DESIROX
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
DEFERASIROX-TEVA contains deferasirox, a non-chiral compound supplied as film-coated tablets. The medicine is available in three tablet strengths: 90 mg, 180 mg, and 360 mg.
Approved indications
— Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. — Treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. — Treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.
Dosing overview
The recommended initial daily dose of DEFERASIROX-TEVA is 14 mg/kg body weight. An initial daily dose of 21 mg/kg may be considered for patients receiving more than 14 mL/kg/month of packed red blood cells, and for whom the objective is reduction of iron overload. An initial daily dose of 7 mg/kg may be considered for patients receiving less than 7 mL/kg/month of packed red blood cells, and for whom the objective is maintenance of the body iron level. Serum ferritin should be monitored every month and the dose adjusted if necessary every 3 to 6 months based on trends in serum ferritin, with dose adjustments made in steps of 3.5 to 7 mg/kg tailored to individual patient response and therapeutic goals. In patients not adequately controlled with doses of 21 mg/kg, doses of up to 28 mg/kg may be considered. Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level. Once serum ferritin levels have reached the target (usually between 500 and 1,000 microgram/L), dose reductions in steps of 3.5 to 7 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation. If serum ferritin falls consistently below 500 microgram/L, an interruption of treatment should be considered.
Regulatory history
DEFERASIROX-TEVA was first registered on the ARTG on 24 August 2021 with three strengths: 90 mg, 180 mg, and 360 mg film-coated tablets.