DASATINIB-TEVA

What it is

DASATINIB-TEVA film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. DASATINIB-TEVA film-coated tablets contain sugars as lactose.

Approved indications

DASATINIB-TEVA is indicated for the treatment of adults aged 18 years or over with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase. — Chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. — Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. — Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. — Ph+ CML in the chronic phase in paediatric patients. — Newly diagnosed Ph+ ALL in combination with chemotherapy in paediatric patients.

Dosing overview

Dosing for children is on the basis of body weight, with dasatinib administered orally once daily in the form of DASATINIB-TEVA tablets (20 mg, 50 mg, 70 mg or 100 mg). The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary. DASATINIB-TEVA tablets are not recommended for patients weighing less than 10 kg.

Key safety warnings

Dose increase or reduction is recommended based on patient response and tolerability.

PBS listing

DASATINIB-TEVA is listed on the PBS in four strengths. The 20 mg tablet is listed with authority required and streamlined restriction, with an ex-manufacturer price of A$221.98. The 50 mg and 100 mg tablets are listed with streamlined and authority required restriction, with ex-manufacturer prices of A$365.62. The 70 mg tablet is listed with streamlined and authority required restriction, with an ex-manufacturer price of A$452.66. All strengths have 7 PBS items.

Regulatory history

DASATINIB-TEVA dasatinib 20 mg, 50 mg, 70 mg and 100 mg film-coated tablets were first listed on the ARTG on 2021-03-18.