Product Dossier

EFERAS

Product Dossier for EFERAS (deferasirox, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

EFERAS is a film-coated tablet containing deferasirox. EFERAS is available in three 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 EFERAS 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 of EFERAS should be adjusted if necessary every 3 to 6 months based on the trends in serum ferritin, with adjustments made in steps of 3.5 to 7 mg/kg tailored to the individual patient's 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. In patients whose serum ferritin level has 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.

Regulatory history

EFERAS was first registered on the Australian Register of Therapeutic Goods on 12 March 2021, with three registered entries covering the 90 mg, 180 mg, and 360 mg film-coated tablet strengths.