TE-DASATINIB

What it is

TE-DASATINIB film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. Tablets must not be crushed, cut or chewed; they should be swallowed whole to maintain dosing consistency and minimize the risk of dermal exposure. Film-coated tablets should not be dispersed, as the exposure in patients receiving a dispersed tablet is lower than in those swallowing a whole tablet. TE-DASATINIB can be taken with or without a meal and should be taken consistently either in the morning or the evening.

Approved indications

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

Dosing overview

The recommended starting dosage of TE-DASATINIB for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of TE-DASATINIB for accelerated phase CML, myeloid or lymphoid blast phase CML in adults is 140 mg/day administered orally once daily. The recommended starting dosage of TE-DASATINIB for newly diagnosed Ph+ ALL in adults is 100 mg administered orally once daily or as clinically recommended. The recommended starting dosage of TE-DASATINIB for adult patients resistant or intolerant to prior therapy is 140 mg/day administered orally once daily. Dosing for paediatric patients is on the basis of body weight. Dasatinib is administered orally once daily in the form of TE-DASATINIB tablets (20 mg, 50 mg, 70 mg or 100 mg). Recommended starting daily dosages for paediatric patients are: 40 mg for body weight 10 to less than 20 kg; 60 mg for 20 to less than 30 kg; 70 mg for 30 to less than 45 kg; and 100 mg for at least 45 kg. Recalculate the dose every 3 months based on changes in body weight, or more often if necessary. Dose increase or reduction is recommended based on patient response and tolerability.

Key safety warnings

TE-DASATINIB should not be taken with grapefruit or grapefruit juice.

Regulatory history

TE-DASATINIB was first listed on the ARTG on 18 March 2021 in four strengths: 20 mg, 50 mg, 70 mg and 100 mg film-coated tablets.