JADENU

What it is

JADENU contains deferasirox. It is available as film-coated tablets 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 JADENU 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 JADENU adjusted if necessary every 3 to 6 months based on trends in serum ferritin, in steps of 3.5 to 7 mg/kg tailored to individual patient response and therapeutic goals. Doses of up to 28 mg/kg may be considered in patients not adequately controlled with doses of 21 mg/kg, but doses above 28 mg/kg are not recommended. In children aged 2 to 5 years, exposure to deferasirox is lower than in adults and this age group may require higher maintenance doses than adults, but the initial dose should be the same as in adults, followed by individual titration.

Key safety warnings

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. The risk of toxicity of JADENU may be increased when inappropriately high doses are given in patients with a low iron burden or with serum ferritin levels that are only slightly elevated.

PBS listing

JADENU is listed on the PBS as 90 mg, 180 mg and 360 mg tablets with authority required and streamlined restrictions. The ex-manufacturer prices are A$14.51 for the 90 mg strength, A$29.02 for the 180 mg strength and A$58.04 for the 360 mg strength.

Regulatory history

JADENU was first registered on the ARTG on 15 March 2018 in all three strengths (90 mg, 180 mg and 360 mg film-coated tablets). In July 2018, the PBAC recommended listing as a Section 100 (Highly Specialised Drugs Program) item for chronic iron overload, noting biocomparability to the dispersible tablet formulation and supporting a cost-minimisation analysis. The PBAC again recommended the product in November 2020 for chronic iron overload.